WO2010028298A1

WO2010028298A1 - Diagnostic system with portable collection housing

Info

Publication number: WO2010028298A1
Application number: PCT/US2009/056112
Authority: WO
Inventors: Richard H. Selinfreund
Original assignee: Sony Dadc
Priority date: 2008-09-04
Filing date: 2009-09-04
Publication date: 2010-03-11
Also published as: EP2324340A1; CN102150032A; CA2736239A1

Abstract

Disclosed is a convenient panel of tests, that may be in disposable form, that allows the user to assess current health status or projected health status.

Description

DIAGNOSTIC SYSTEM WITH PORTABLE COLLECTION HOUSING

RELATED APPLICATION

This application claims priority to U.S. Provisional Patent Application 61/094,356 filed September 4, 2008 and U.S. Provisional Patent Application 61/166,446, filed April 3, 2009, both of which are incorporated by reference in their entireties.

BACKGROUND OF THE INVENTION

FIELD OF THE INVENTION

[0001] The present invention in one embodiment generally relates to the testing of physiological markers enabling a user to make active decisions regarding health status and possible health issues that may arise owing to health choices made by the user. There may be provided a convenient panel of tests, that may be in disposable form, that allows the user to assess current health status or projected health status based on the user's lifestyle practices, such as, for example, on diabetic fitness. The user can then modify lifestyle practices to achieve a favorable result.

DESCRIPTION OF RELATED ART

[0002] More and more Americans are assessing their personal health in the privacy of their own homes, using oral swabs, tears, a few drops of blood, or a urine sample to test for blood glucose levels, cholesterol levels, markers for colon cancer, and markers for rectal cancer. These tests generally indicate the health status of the user, at least with respect to the single physiological marker tested, and provide evidence so that the user can make private, health-related decisions concerning his/her health. The "at- home diagnostic market" (which only includes test kits that reveal results at home) has doubled since 1999, from roughly $2.9 billion dollars in world wide sales to greater than $6 billion in 2005. Globally, the Point-of-Care market is estimated at 33.6 billion in 2007 with the United States market representing the largest portion. [0003] Commercial laboratories and point-of-care facilities have a need for quick and relatively easy tests for assessing health status.

[0004] A companion diagnostic is defined as a privately used device that may have one or more disposable components for Point-of-Care and/or in-home use, that provides immediate evidence relevant to the health status of the user. A commercial diagnostic is defined as a non Point-of-Care test device that may have one or more disposable components that provides evidence relevant to the health status of the user and/or patient. Such evidence may found, for example, by measuring the levels of pertinent physiological substances (or analytes) in the blood, tears, urine, feces, saliva, mucus, or the exhaled breath of the user. It is preferable that such tests be non-invasive, that is upon sampling not penetrating the epithelial barrier of the user.

[0005] Desirable physiological variables that could be analyzed by a companion or commercial diagnostic are those that have been found to change in a known way or in concerted ways depending the health status of the user. One such test is for blood glucose level, a test that is commonly and routinely used. This is an invasive test, in that a blood sample must be obtained from the user. For diagnosis, any such measurement or combination of measurements needs to be compared with pre-existing diagnostic criteria for interpreting those measurements. A shortcoming of many of the currently available companion diagnostic devices is that only one physiological variable is analyzed at a time by these devices.

[0006] Over the past century, the prevalence of certain health concerns has increased in line with changes in eating habits and diet, working patterns, and lifestyle choices. The following is a listing of some of these concerns: diabetes, stress, ageing, bone health and osteoporosis, cancer, HIV, digestive health, external appearance, fatigue, fertility; and heart and cardiovascular health. Obesity is a national problem and is understood to be strongly related to lifestyle choices. Another particularly important, and immediate health concern of individuals, and the community as a whole, is diabetes mellitus. Lifestyle choices are expected to significantly affect the progression of diabetes. [0007] Diabetes mellitus is of the juvenile (Type 1) or adult onset (Type 2) forms. In the Type 1 form, insufficient levels of insulin are produced by the Islet cells of the pancreas to enable glucose uptake by respiring cells. Type 1 Diabetes is also known as Insulin-Dependent Diabetes (IDD). In Type 2 Diabetes, insulin is produced by the pancreas at sufficient levels, but for other reasons blood glucose is not efficiently absorbed. Type 2 Diabetes is also known as Non-Insulin Dependent Diabetes (NIDD). With respect to the adult onset form, Type 2 Diabetes, obesity is known as a strong risk factor for developing the disease. The Type 1 form is a consequence of complicated immunological and auto-immunological factors. Generally, the degree, responsiveness to therapy, and severity of Type 1 Diabetes, Type 2 Diabetes, and obesity, and the interactions between these conditions, is referred to herein as "diabetic fitness". An individual is more "diabetically fit" if the individual has greater physiological control over blood glucose levels, is more responsive to therapy, and is more responsive to dietary modifications.

[0008] A method for assessing the effects of lifestyle choices on the progression or subsidence of these conditions would be valuable. Convenient, private companion diagnostics would allow a user to make choices that will improve diabetic fitness and lifestyle, and over time modify those choices as desired, depending on a series of diagnostic assessments.

SUMMARY OF THE INVENTION

[0009] The instant invention includes in one embodiment a companion diagnostic device for assessing fitness and improving lifestyle choices to improve overall fitness. Such embodiment device provides a plurality of test results in a convenient, compact form and allows Point-of-Care usage. The companion diagnostic device may be used to identify and measure numerous physiological parameters, related to such parameters as diabetes, stress, ageing, bone health and osteoporosis, cancer, HIV, digestive health, external appearance, fatigue, fertility; and heart and cardiovascular health. Likewise in another embodiment there is disclosed a commercial diagnostic device for assessing fitness and improving lifestyle choices to improve overall fitness. [00010] Embodiments disclosed herein include an apparatus and method for cost-effectively performing medical, biological or chemical tests in the field. In each case, the objective of the test is the detection of the presence or characteristic of a specified target compound. While many of the embodiments disclosed, are described with reference to medical testing, other embodiments may be applied to other areas such as, without limitation, biological testing, chemical testing, environmental testing, food safety and security monitoring.

[00011] Disclosed herein in an embodiment is a portable collection housing comprising one of more collector wells or spots designed to operatively coact with an electronic monitoring device configured to obtain information related to the status of such wells. Such portable collection device is preferably configured to allow for sealing of such wells after addition of sample matter. The wells of such portable collection housing comprise one of more test materials or reagents that are selected to react with organic or inorganic sample matter. The test sites of wells may be associated with one or more sealable portals through which test sample that may contain an analyte may be added, and/or through which reagents may be added. In an embodiment, two or more test wells that are to receive the same test sample are interconnected to a common portal to allow a set sample size to be distributed between the interconnected wells. The common portal may be covered, for example, with a septum, a distributing bulb, or may be an opening with a closing device (such as a tethered plug or cap).

[00012] In a companion diagnostic system embodiment, there is found a portable collection housing which comprises a substrate having a plurality of test compartments therein having at least one surface having a construction capable of being interrogated by a monitoring transmission (e.g., a transparent window). Within one or more of the plurality of test compartments there is found a test material that selectively reacts with a defined analyte. Further provided in the system is an electronic monitoring device comprising a housing having a docking portion configured to co-act with the portable collection housing. One or more, preferably a plurality of, monitors in said co- acting docking portion are configured to use a monitoring transmission to monitor each of the plurality of test compartments through the interrogatable surfaces of the same in a manner to detect changes in the test compartments due to reaction between each test material and its corresponding defined analyte. Monitor(s) of the electronic monitoring device may comprise both activating transmission circuitry, and detector circuitry, together or physically separate from one another. Monitors may be in one embodiment a transceiver. The electronic monitoring device preferably also contains a processor operatively connected to the one or more, preferably a plurality of, monitors, the processor being configured to process information pertaining to detected changes in each of said test compartments, and a memory operatively connected to the processor, the memory being configured to store information pertaining to detected changes in one or more of the test compartments, and to store algorithms relating reactions between one or more test material/defined reactant, and a physiological or chemical status. The processor itself may be further configured to process these algorithms stored in the memory and to output information pertaining to physiological or chemical status based upon the results of said algorithms. Such information may be in raw form for further processing by another processor, or may be information that directly provides insight into physiological or chemical status.

[00013] The test material may have a binding affinity for an inorganic compound, such as (without limitation) lead or mercury, or a binding affinity for an organic compound, such as (without limitation) a viral capsid, a DNA sequence, glucose, lactic acid etc.

[00014] In one embodiment, the portable collection housing has portions of a surface thereof coated with a specialized test material. The test material is selected to cause a measurable response in response to the application of an analyte, or in response to an analyte and at least one second reactant. The application of the sample to the test area, and the assay protocols may be controlled by a reaction chamber subject to internal software controls, external software controls, or a combination of internal and external software controls.

[00015] In one embodiment, the optical properties of the test material are designed to change in response to contact with the target analyte. [00016] Specific test materials may comprise materials which, prior to application of the specimen to the material, are characterized by a first optical property state, but upon application of the analyte displays a second optical state to a laser reader, for instance. As an example, the first optical property state might be of such opacity that it blocks the propagation of light from the laser to a monitor, however, upon application of an appropriate analyte the opacity may change allowing a portion of the light to propagate through the test material. The degree of propagation of the light through the test material maybe proportional to the concentration of analyte interacting with the reagents.

[00017] In an embodiment of the present invention the portable collection housing is multi-component. In one embodiment there is a first component comprising wells and/or positions having test materials and/or reagents affixed, and a second component that coacts with the first component to hold the same. In another embodiment there is a third component that is configured to coact with the second component to enclose the first component sealing the wells or positions having the test materials between same. In yet another embodiment there is a fourth component that provides for sorbency that is designed to fit over the wells and/or positions on said first component when said first and second components are coacted.

[00018] The portable collection housing is designed to operatively coact with an electronic monitoring device configured to obtain information pertaining to the status of the test material wells or sites. Coaction may be physical coaction between the portable collection housing and the electronic monitoring device, or by the transmission of data between same, as by wireless or wired communication there between. The electronic monitoring device may having a docking portion that allows for physical docking of the portable collection housing with the electronic monitoring device.

[00019] For many specific medical applications, the cost of the test material is a major expense driver. Minimization of the amount of test material is therefore an important consideration. By allowing electronic detection of a change, less material may be needed (as opposed to if the change had to be humanly readable by the eye). In addition, some test protocols require multiple tests, using different test materials, to be performed on the same specimens. Embodiment herein allow for multiple tests to be performed at once.

[00020] In one embodiment, one or more test materials that comprise quantum dots are used.

[00021] A further embodiment provides for multiple tests to be performed using a single portable collection housing. Separate portions of the portable collection housing may be coated with, or interned with, different formulations of specialized reagents and test materials which respond to separate analytes. The results of the individual tests may be combined, by means of a software implemented algorithm, to provide a composite diagnosis (such as a patient likely has diabetes, or a water sample contains hazardous levels of lead and mercury).

[00022] In an embodiment the electronic monitoring device has incorporated thereon software that is configured to cause the device to transmit data pertaining to the read at one or more test material sites associated with the medium, to a remote site over a wide area network, such as the internet, along with information pertaining to the IP address of the transmitter. The remote site then may process the information at said one or more test material sites and transmit to the transmitter's IP site a tentative diagnosis and/or transmit a tentative diagnosis to a health professional or other professional (such as a water treatment expert) designated by the transmitter with a request for a follow-up appointment.

[00023] In an embodiment, a reaction chamber is also included that may be designed to facilitate and enhance a signal corresponding to reaction of an analyte in a specimen with the test material on the portable collection housing so as to make it detectable by the electronic monitoring device. This 'detectable signal' represents a combination of events associated with the contact or change in proximity of the analyte to the test material. These events comprise binding, diluting, concentrating, chemically reacting the analyte with a reagent in the test material and/or secondary reagents to yield a detectable signal. Of the chemical processes involved, a reaction chamber may be used that permits maximization of signal production by manipulating both the thermodynamic and kinetic properties of the reaction components needed to produce a detectable signal. These include temperature control and the additions of catalysts such as metals and enzymes to reduce activation energies. This flexibility allows laboratory-like physical and chemical manipulation in a home or doctor's office, and therefore, vastly expanding the range on analytes and samples suitable for analysis.

[00024] In an embodiment, the specimen is applied to that portion or portions of the portable collection housing having the test material. If the specimen contains the targeted analyte, a property of the test material may change, for example there maybe fluorescence or a change in optical state from a first optical state to a second optical state. The change optical state might affect read of data under the test material, such that data readability is used to determine the presence or absence of the analyte. In an embodiment, the test material may be applied to the wells or sites associated with the portable collection housing, or component thereof, using high speed low cost printing techniques.

[00025] In one embodiment, the test materials are interacted with the sample, and the medium dried before read by the electronic monitoring device. In another embodiment, the test materials are monitored when wet or in solution. In one embodiment, the portable collection housing has test materials thereon that require different sample preparation, or different samples to be applied thereto, hi such embodiment, there is provided with such medium multiple demarcations thereon to indicate wherein different sample, or sample preparations, are to be applied. External reagents that may be required for reaction between the sample and the test material may be indicated by such demarcations. In one embodiment, the reagents need may be located within the demarcation, as for example, encapsulated within microcapsules that are broken, for example, by pressure, heat (as for example, from a laser read), or by salvation of the encapsulation when a reagent or a solvent is added.

[00026] In a particular embodiment, the portable collection housing provides an area or memory to place readable or retrievable information, such as an authentication signature, or information pertaining to a read of a well This provides information may be used to determine an authentication chain.

[00027] In embodiments, the component of the portable collection housing bearing the test material may be provided in a hermetic case designed to reduce the break down of the test material, and/or reagent, and to protect against degradation by the external environment.

[00028] In one embodiment, the portable collection housing contains electronic circuitry, such as a processor and/or memory. The electronic circuitry may be activated by the electronic monitoring device. Such circuitry may provide information to the electronic monitoring device as, for example, the protocol to monitor each test material well or site, or may be activated by the electronic monitoring device to provide an activating signal to the well or site, for example, an electric current. In one embodiment, the portable collection housing has an RFID or similar device that allows for a unique identification to be associated with the medium. In another it includes memory for storage and retrieval of information pertaining to test results. In such electronic embodiments of the portable collection housing, the housing may have an interface or portal to allow for flow of data to be transmitted to the electronic monitoring device or other data processing device, and/or receipt of data from the electronic monitoring device or other data processing device. Received data from the electronic monitoring device or other data processing device, may cause a change in the monitoring (such as, for example, altering the wavelength of the read, duration of read, etc.) of one or more test compartments, or a re-read of the same. In one embodiment, the interface or portal, and/or portion of circuitry thereon, is formed using a conductive ink such as Cabot CCI-300 or VoaCentrix Metalon Inks (Austin, TX 78728).

[00029] The portable collection housing and/or electronic monitoring device may contain instruction code designed to check the position where one or more test materials are located on the medium and the state of the test materials. The state of the test materials may be adjudged, for example, by detecting optical changes in the test material, or in data which may be associated with the test materials (e.g., the test material may lay over data indicia and the read of the data indicia changes when the state of the test material changes). Based on the state of such one or more test materials, the instruction set follows a pre-deterrnined algorithm to output a signal indicative of the health or physiological condition of the person using the companion diagnostic device or the applicable patient. In one embodiment, such algorithm makes use of detected optical changes in test materials in two or more locations, three or more locations, or four or more locations in order to output a signal indicative of the health or physiological condition of the person.

[00030] In another embodiment companion diagnostic device, there is provided a "portal interfacing electronic device," designed for interfacing through a portal on a computing device, or electronically sending transmission thereto. Such portal interfacing electronic device may be a "dongle," similar in appearance and to a "thumb drive," or other electronic device designed for coupling with a computing device. In one such embodiment, the portal interfacing electronic device has one or more compartments in the same, that allows for communication with the environment surrounding the portal interfacing electronic device. Preferably such compartments are sealable. In one embodiment, the compartments have slidable doors, that may be transparent, translucent, opaque, or have special filter properties, that allow for sample to be deposited into the compartment when the doors are open, but also allow for the sample placed into such compartment to be sealed therein when the doors are closed. The compartments may also be re-sealable by other means, for example, by use of a rubber septum (with the sample injected through the septum), or re-sealable tabs, and other such known sealing mechanisms. Associated with such wells may be one or more monitoring devices that monitor the materials in the well. Such monitors may include, without limitation, spectrophotometers, fluorescent detectors, electrical parameter detectors, color detectors, etc. Information from said detectors can be stored on the portal interfacing electronic device and/or in the computing device to which it is interfaced. The computing device based on such information may control retrieval of information from the monitors. Such embodiment provides the advantage of allowing interrogation of a wet sample, which may be necessary or desirable in respect of certain reactions between the sample and test material. Of course, dried reactant (that is, dried test material plus dried sample) may also be interrogated. It also protects the test material from being degraded or inadvertently handled. It also allows for a broad range of tests, including, for example, gene tests via gene chips. Read may entail detection of changes in electrical and/or magnetic, or electromagnetic properties across the sample, or other properties, such as light transmission changes. In an advantageous embodiment, two or more reads of any well are made in respect of making any diagnosis or prognosis.

[000311 One portable interfacing device embodiment comprises a component having a plurality of test compartments therein, each of the test compartments comprising a test material reactive to a defined analyte, and being configured to be capable of receiving a volume of a test sample. Furthermore, such portable interfacing device includes one or more monitors coupled to the test compartments, each configured to detect changes in the test compartments related to reaction of the test material with its corresponding defined analyte. The monitors are operatively connected to a processor configured to obtain information pertaining to the detected changes in each of the test compartments. The processor may further be configured to send information to an external processing source. Further included is a memory operatively connected to the processor, with the memory configured to store information pertaining to the detected changes in the one or more of test compartments and to store algorithms relating reactions between one or more test material/defined analyte and physiological or chemical status. In one embodiment, there is a plurality of monitors operatively connected to the processor. A prepared portable interfacing device allows test materials/reagents/samples to be removed from the wells when finished and new test materials and reagents added (of course, with new sample being added later).

[00032J In one case, instruction sets associated with the portable collection device/electronic monitoring device or portable interfacing device may require that the person using the same to input one or more physiological conditions or physiological parameters (e.g., blood glucose level, metabolic pH state, etc.) The instructions associated with the portable collection device and/or electronic monitoring devices - portable interfacing device may cause display to the user of the companion device alone or, for example, a display attached to the optical reader. [00033] Instructions as to appropriate application of the sample and any required reagents for the test, may be provided in an attached pamphlet or manual, or may be provided in data encoded in the portable collection device and/or electronic monitoring devices, or portal interfacing device that may be read into audio and/or video instruction.

[00034] Diagnosis or prognosis may also be based on algorithms that require other non-test material related parameters, such as weight, urine output, color of sputum, beyond the results gleaned from interrogation of the reaction spots resulting from interaction between the sample and test material. Such algorithms may display the need for input by the user by displaying to the user, the need for the information but before a tentative diagnosis or prognosis is made. A computing device interfaced with portable interfacing device and/or portable collection device may be programmed either alone, or by instruction provided by the same, to seek and process such information.

[00035] Multiple test materials may be associated with the medium with the patient selecting the condition or physiological status which the patient desires to be monitored. For example, test materials on the medium may be used to monitor one or more conditions or physiological state, e.g. diabetes, heart health, exercise induced acidosis, bacteremia. The affect of the sample on more than one test material may be need to for the program to provide tentative diagnostic output, or physiological parameter monitoring. For example, change in one test material may indicate acidosis, while change in another test material may relate to an abnormal glucose level. Changes in both may be need to make a tentative diagnosis of a certain condition such as diabetes.

[00036] To verify the accuracy of any read, one or more control spots, or wells comprising a test compartment, may be necessary. Persons applying reagents, test materials, or sample to the medium may not appropriately follow directions, or the medium itself may sport reagents and/or test materials that have degraded. By application of control spots or wells, false negatives and/or false positives may be greatly reduced. Such spots or wells may be designed to display certain reactivity if the sample is appropriately treated. Control spots or wells may require exogenous material to be added thereto, or may have associated therewith reagents that are solubilized when sample or a solvent is added, or in the case of encapsulated reagents, break with the appropriate addition of pressure, solvent, or heat. Algorithms may be incorporated onto the medium that disregard or accept reads form different spots or wells (that is, from the test compartments) based upon whether control spots or wells show appropriate reactivity.

[00037] In an embodiment, a reaction chamber is provided that includes a processor and reader of the particular medium being placed into the reaction chamber. The processor may be configured to detect which of a number of medium types have been placed into the reaction chamber and what type of test material is associated with the medium. The processor may then alter conditions within the reaction chamber such that conditions within the reaction system favor reaction, or provide more favorable reaction conditions, of the test material which may be found in a sample applied to the medium. Conditions that may be altered include, but are not limited to, temperature, cyclic temperature, relative humidity, light/dark exposure, and the types of materials within the ambient environment (such as solvents, reagents etc. being added to the environment surrounding the medium, or directly to the medium itself).

[00038] One reaction chamber embodiment includes external material application modules which are configured to hold materials and to allow for application of such materials into the reaction chamber. The materials may include, for example, materials that facilitate chemical reactions and/or physical changes on the medium to yield and amplify a detectable, or more detectable, signal corresponding to the presence and amount of the analyte.

[00039] A reaction chamber may be designed to automatically execute multi- step protocols to change the environment about the medium. For example, the environmental conditions within the reaction chamber, and about the medium, may be altered over time such that reaction conditions may be optimized, or more fully optimized, to allow reactivity between a first test material or reagent on the medium and a potential analyte in the specimen, and then optimized, or more fully optimized, to allow reactivity between a second test material on the medium and its potential analyte in the specimen, and likewise, for a third test material that may be on the medium.

[00040] In an exemplar use, a sample, for example, a blood sample, or a sample of a material (e.g. dissolved paint), is applied to an area of the portable collection housing component with the test material associated therewith and then placed into the reaction housing chamber.

[00041] In one exemplary embodiment, the companion diagnostic device gives the user direct feed back on the user's diabetic fitness level over time. The device shows the effects of diet and food choices made by the user by providing a plurality of physiological measurements in the form of a test panel. The panel of tests can show dietary metabolites that are adjudged positive or negative markers for a diabetic diet. In one exemplary embodiment a panel of markers helps the user make advantageous food choices for the user. When the companion diagnostic device is readable by a device connected or connectable to a networked system, the companion diagnostic device may send information about the panel of tests to a remote location for analysis. On the other hand, analysis may be made on site by use of algorithms associated with the companion diagnostic device or the device upon which the companion diagnostic device is read.

[00042] The companion diagnostic device or commercial diagnostic device may or may not be reusable, depending upon whether the test material is changed in a reversible or non-reversible manner, and whether such device permits the addition of fresh test material and reagents. The portable collection housing that is designed to operatively coact with the electronic monitoring device has the advantage that the component of the same sporting the test material may be discarded and replaced with another analytical component sporting test materials as the type of test to be performed changes. In an embodiment portal interfacing electronic device the device permits washing out of test material and/or reagents and the placement of new test material and/or reagents into the well. In such embodiment, there is provided to the portal interfacing electronic device new instructions as to the processing of the test material-sample to obtain the reactivities desired. Such instruction may be provided from medium or device separate from the portal interfacing electronic device, such as input from the internet or other widely distributed network, or a program provided with a separate kit for a new parameter to be determined using a defined portal interfacing electronic device.

[00043] A patient in any case may monitor daily, multiple times per week, weekly, monthly etc. for a condition or physiological parameter and send the information to a remote location, or storage the information in a database proximate to the patient, which such multiple data being useful for determine how a patient's lifestyle is affecting their health. The latter may provide physician's and patients with more accurate information than would be obtained relying on oral history based on recollection. Further, monitoring in such manner may lower long term cost to a patient, by allowing lifestyle problems to be identified early. Many conditions are reversible if detected early.

[00044] In one exemplar case, diabetes and endothelial dysfunction associated with the pathogenesis of both micro and macroangiopathy in diabetes are monitored. Markers for endothelial dysfunction may include von Willebrand factor, and vascular cell adhesion molecules. Markers for vascular disease damage and diabetes progression may serve as early markers for disease progression for both states (see, K. Tan, Proceedings of the 13^th International Atherosclerosis Symposium vol. 1262, May 2004 pp 511-514). Earlier markers which may be monitored for endothelial dysfunction and diabetes may include: LDL, HDL, Cholesterol, C-reactive protein (CRP), nitric oxide levels, soluble intracellular adhesion molecule 1 (slCam-1) and PAI-I, and endothelin 1, many of which such markers have been found by the present inventors to be present in saliva. Other markers that may be monitored may be triglycerides, in saliva or blood or ratio levels, such as HDL/LDL level. One or more of such makers may be used for early detection of diabetes or vascular disease, or other conditions. For example, endothelial dysfunction has been associated with the pathogenesis of both micro and macroangiopathy in diabetes and may be demonstrated in patients with type q and type 2 diabetes mellitus. Markers for endothelial dysfunction (e.g. von Willebrand factor, vascular cell adhesion molecules) may be elevated in patients with diabetes. Thus the same markers for vascular disease damage and diabetes progression may serve as early markers for disease progression for both states (K. Tan, Proceedings of the 13^th International Atherosclerosis Symposium Vol. 1262, May 2004 pp. 511 - 514). In early onset diabetes patients may not have abnormal blood sugars, but may have elevated markers for blood vessel inflammation. These patients may be detected even though they have not yet developed clinical diabetes.

[00045] In one embodiment, a test sample is obtained using an oral swab. In another embodiment, a test sample is obtained by exhaling into a collection device which has material for absorbing the exhaled air or component thereof. Application of where the sample should be provided, may be by way of instructions separate form the medium or may relate to instructions appended to the same.

[00046] In one embodiment, the companion diagnostic device provides results in near real time in the user's residence. In yet another embodiment, the test sample is transmitted to a testing center, from which test results are obtained on a timely, confidential basis.

[00047] Feedback may also be provided on the affect lifestyle is having on a patient. For example, the diabetic state may in some cases be controlled by diet and exercise. By adequately monitoring the condition of the patient over time, long term cost for diabetes care may be reduced, for example by the prevention of the progression of vascular disease.

[00048] Examples of relevant physiological markers suitable for a companion diagnostic directed to diabetic fitness are: insulin level, catecholamine status, triglyceride level, carbohydrate level, respiration quotient, as well as genetic markers, such a Nhe-1, that suggest a susceptibility to Type 1 Diabetes.

[00049] Generally, when a sample is analyzed, a plurality of tests are performed on the sample and a panel of test results obtained. To evaluate the significance of the results, the test panel is then compared to pre-existing diagnostic or performance criteria for those results. It is also envisioned that the test results may be interpreted independently by the user, if desired, based on the user's personal preferences, experiences and perceptions of the significance of the test results. [00050] It is further envisioned that testing may be strictly non-invasive, and that independent, separate measurements of the user's blood glucose level, using methods known to artisans, would optionally supplement the panel of test results provided by the instant invention.

DESCRIPTION OF FIGURES

The following detailed description, given by way of example, will be best understood in conjunction with the accompanying drawings in which:

Fig, 1 is a simplified schematic drawing of a portable collection housing and components.

Fig. 2 is a simplified schematic drawing of a electronic monitoring device for co- action with a portable collection housing such as shown in Fig. 1.

Fig. 3 is a simplified schematic drawing of a portal interfacing electronic device.

Fig. 4 is a simplified flow chart of the diagnostic process that may be employed by devices disclosed herein.

Fig. 5a is simplified schematic drawing in vertical view of one embodiment of a portable collection housing comprising test compartments comprising a fluid distribution system.

Fig. 5b is an additional simplified schematic of the portable collection housing of Fig. 5 a shown in side perspective view.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

[00051 ] Test applications include medical and home lifestyle monitoring. Turning to Fig. 1 , there is shown an embodiment portable collection housing 7. As is shown in such embodiment, the portable collection housing 7 is multi-component. Base component 5 comprises a window 12 portion that allows for interrogation therethrough. Intermediate component 10 comprises a strip comprising multiple wells or sites 11 having associated therewith test material. As shown part 15 may be configured to coact with base component 5, so as to allow interrogation of the wells through window 12 of base component 5. Top component 20 is designed to coact with base component 5, to seal the environment from direct contact with the wells of intermediate component 10. Optionally a fourth or further component may be provided. As shown, a fourth component 21 comprising sorbent material is shown. Such sorbent material may be useful to provide reactants or protect test materials from degradation or contamination.

[00052] Turning to Fig. 2 there is shown an embodiment electronic monitoring device designed to operatively coact with the portable collection housing. The embodiment as shown shows coacting structure 30 to provide for physical coaction with the portable collection housing. Electronic monitoring device 25, as shown, has processor 35, memory 40, data portal 45 and one or more monitor and excitation detector points 50. Data portal 45 may receive processing instructions from storage on said portable collection housing via said data portal 45. Such processing information may affect parameters set on detectors 50. The device of 7 may include a transmitter 14.

[00053] The test compartments contain specialized test material which comprise reagents specific for the intended analyte or class of analytes . Such reagents include substances to facilitate a change in optical state such as an acid generating system and a dye. Of course, any parametric change which is capable of being detected by the reader of the medium may be employed. In one case, when the reagent designed for the specific analyte in the specialized test material engages the analyte, the acid generating system is activated changing the absorption maximum of the dye.

[00054] Once a specimen is applied to the test compartment containing the specific reagent needed for the intended analyte, a parametric change, such as in absorbance or in opacity may be monitored. The monitoring procedure may be implemented using software.

[00055] One or more of the control sites or wells may comprise what would be otherwise a test compartment 11. Such control sites or wells may be dedicated to the performance of test controls. These sites may be configured to validate the test results with respect to one or more test spots or wells by providing confirming responses to reference samples. Test controls may be provided, without limit, for confirming the appropriate environment (for example, temperature, humidity, pressure, light, etc.), or for confirming the efficacy of the reagents or the reaction of the reagents and the environment on a "known" sample. In some cases the control responses may be obtained without a reference sample. The test sites or wells or compartments may be associated with one or more sealable portals through which test sample that may contain a reagent may be added, and/or through which reagents may be added.

[00056] In an embodiment, two or more test wells that are to receive the same test sample are interconnected to a common portal to allow a set sample size to be distributed between the interconnected wells. The common portal may be covered, for example, with a septum or cap, a distributing bulb, or may be an opening with a closing device. A set amount of material test sample is added to the common portal and distributed through conduits attached to the same to the appropriate wells. Premixing mechanisms may be employed to improve distribution.

[00057] After application of the specified biological samples to each of the test sites 11 , the samples may be processed, as required, to execute the respective test. Alternatively, the biological samples may be treated before application to the test site (or before and after application to the test site). Execution of the test may require varying environmental conditions in a prescribed manner to obtain the desired results. Specifically, the varied environmental conditions may comprise temperature, humidity, pressure, exposure to reagents, exposure to light of specified wavelength, exposure to ionizing or non-ionizing radiation, or other agents. The necessary environmental conditions may automatically be provided by a test performance apparatus which receives the substrate, containing the applied biological samples, and executes the test according to a pre-programmed regimen for the test materials. The regimen in an advantageous embodiment, causes two or more reads of the test material spots by the reader in order to validate any particular read. The regimen may also cause prolonged read of a site, such as slowing the typical speed of the reader. Such prolonged read may be necessary when reactivity is promoted by the reader beam or signal. [00058] Each of test sites 11, at the conclusion of the test regimen, may manifest the test results in the form of a measurable change to the characteristics, of the sample and the reactive materials, at the test site. Exemplary changes may include changes in optical properties, magnetic properties, electrical properties, or other physically measurable charateristics. The measurable changes, resulting from the test procedure, may be detected and quantified by electronic monitoring device. The electronic monitoring device may interrogate each of the test sites 11 and record the results of each of the tests.

[00059] The test measurement results may be combined with other patient- specific related data and condition- or disease-specific data to formulate a potential evaluation or diagnosis. For example, software may request information from the patient about physiological status, such as age, height, and family issues. In an embodiment, the formulation of the evaluation or diagnosis may be automatically performed by diagnosis software. The diagnosis software may be part of the medium or system or, alternatively, at a remote location 130. For remote location implementation, communication between the medium and the processor processing the diagnosis software may be provided by suitable point to point or network means, such as the INTERNET 140. In addition, the distribution of the results of the tests may be restricted by a password access system or other security means.

[00060] An embodiment system may be controlled by software implemented by a computer. Fig. 4 is a simplified flow diagram of a flowchart of an embodiment. The data stored on the portable collection housing 1 is read 200 by the electronic monitoring device 25. The first test site is located 210 by reader 100. The characteristics of the sample at the test site are measured 220. If the measurement 220 provides positive results, the results are output 240. After the results are outputted, the process queries whether there are any more test sites 250. If the results are not positive, the process similarly queries whether there are any more test sites 250. If there are more test sites, the process goes to the next test site 260. If there are no more test sites, a diagnosis is generated 270, and the process is ended 280. [00061] Fig. 5a is simplified schematic drawing in vertical view of one embodiment 800 of a portable collection housing comprising test compartments linked by a fluid distribution system. Receiving location 810, serving as a portal, is connected by distribution channels 815 to test compartments 820. Fig. 5b is an additional view of Fig. 5a, in side perspective, again showing receiving location 810, distribution channels 815 and test compartments 820. Additionally illustrated is cap 825 and flexible binding strip 830 that attaches cap 820 to the portable collection housing, optionally reversibly sealing receiving location 810. In this embodiment, upon the removal of cap 825, a liquid sample may be simultaneously introduced into receiving location 810 and distributed via distribution channels 815 to test compartments 820 that contain appropriate test materials.

[00062] One exemplary embodiment formulation of the test material that may be printed may comprise: 4-120 mg/ml reactive acid generator (the charge on the droplets being in a range from 900 μSiemens/cm to 1800 μSiemens/cm); 2 mg/ml - 16 mg/ml medical reactive dye; 3-5% of some water soluble binder used to increase viscosity to 2.0-4.0 cPoise; and 95-98 % of ethanol.

[00063] In one embodiment, the reagents and/or one or more reactants are employed as nanoparticles or quantum dots.

[00064] Test samples suitable for analysis using the systems described herein include all bodily fluids and tissues, and any environmental liquid or solid. Examples of test samples are blood, urine, saliva, feces, sweat, wound exudates, nipple aspirates, etc. Other analytes include, without limitation, water (to check for minerals, contaminates etc.), paint chips, foods, liquids, and aerosols. Liquids in some embodiment may be applied to a test material by means of a capillary tube or rod while solids may applied as a smear with or with out a solvent. In an additional embodiment, the sample maybe a thin section of organic or inorganic material fixed to the test area spot of the substrate prior to insertion into the reaction chamber housing. In one embodiment, particular genes maybe probed using methods of fluorescence in situ hybridization (FISH). This type of analysis is particularly well suited the reaction chamber described herein since multiple washes are required. [00065] In another embodiment the portable collection housing and/or electronic monitoring device includes software that is configured to cause the reader, or a processor connected to the reader, to transmit data pertaining to the read at one or more test area sites associated with the medium, to a remote site over a widely disseminated network, such as the internet, along with information pertaining to the IP address of the transmitter. The remote site then may process the information at said one or more test material sites and transmit to the transmitter's IP site a tentative diagnosis and/or transmit a tentative diagnosis to a professional designated by the transmitter.

[00066] Another embodiment is the detection of biomarkers to enable individuals in a clinical or home setting to predict medical consequences. Biomarkers are generally molecular entities that serve as surrogates of clinical end points. Biomarkers predict risk of disease, success or requirements of therapeutics, and diagnose disease. For example, cholesterol levels and LDL levels correlate with heart disease and the level of Hbalc glycosylation is diagnostic for diabetes. Additionally biomarkers also predict if an individual will respond or not respond to a particular therapeutic. For example, lung cancer patients that over express HER2 receptor may respond to monoclonal antibodies designed to block that receptor such as Herceptin. Biomarkers are also of great value in determining if drugs are engaging the designated target and to what duration the target is engaged. For example, measurement of cyclooxygenase activity in the blood demonstrates to the individual taking aspirin that the drug is working and how long it is working. These biomarkers of efficacy may also be used for infectious diseases to determine microbe eradication needed by health professionals to determine whether to continue or change the therapeutic in a timely fashion. This could be done prior to worsening clinical manifestations with said optical medium. This is of particular importance for individuals in remote areas. DNA or RNA probes may also be included to detect specific entities or patterns that may indicate sensitivity to treatment or disease.

[00067] Biomarkers are also useful for determination of "off-target" effects of therapeutics. "Off-target" refers to unintended targets such as enzymes and receptors in the design of the drug. All drugs have "off-target" effects. Some off-target effects are toxic, others have neutral and some contribute to the efficacy of the therapeutic. Knowledge of unique and individual off-target effects are of great value particularly to those with numerous risk factors. Monitoring of toxicity biomarkers can be of critical importance to individuals. Early knowledge of elevated liver enzymes, or elevated lactate dehydrogenase from damaged cardiac tissue or elevated of C-reactive protein in hyperlipodemics can be an immediate signals to seek help and to alter activities.

[00068] Another embodiment is the diagnosis of diabetes. This could be accomplished in three complimentary ways with the optical medium described herein. Blood or urine glucose can be measured directly in a fasted or fed state. Glucose tolerance may also be measured by including a glucose load and measuring blood glucose in incrementally time intervals before and after the load. Finally, long term exposure to glucose can be made by measuring the degree of the glycosylation of HbI Ac. HbIAc measurements are of particular value for diagnosis and determining the severity of diabetes since it is not vulnerable to confounding due to the common fluctuations in plasma glucose. Assessment of these analytes, with the optical medium herein, for the diagnosis require the selection of the proper reagents comprising the test material. In this case, chemical or enzymatic reagents can be chosen for glucose and an antibody can be chosen for HbAIc to comprise the test material. For example, as mentioned above, the specialized test material is printed onto the medium. The specimen and appropriate controls are applied to the printed test material spot or spots.

[00069] With respect to glycosylated hemoglobin, a value of 4-6% is considered normative. If the fraction of glycosylated hemoglobin exceeds roughly 6.5 %, the assay is consistent with a diabetic pathology. An assay procedure to measure glycosylated hemoglobin may comprise the following steps: capture an anti-hemoglobin antibody at the test site; detect the glycosylation status by binding a fluorescent wheat germ agglutin conjugate after washing away unbound agglutin; measure the amout of bound lectin; use an additional anti-hemoglobin antibody (or a protein stain) to determine the total of protein molecules captured; and, calculate the ratio of the the agglutin and total protein signals. [00070] Similarly Lyme disease can be diagnosed by designing a specific test material for Borrelia burgdorferi or a pathologically relevant genetic variant. This reagent can be an antibody and the control antibody can be directed to a similar but benign spirochete. Analogously, HIV can be detected and the clinical progression of HIV to AIDs or the success of therapeutic intervention can be similarly monitored with reagents directed towards the virus and CD4+ cells.

[00071] Similarly, sexually transmitted diseases such gonorrhea, Chlamydia and infectious diseases may be detected. DNA probes may also be included in the test reagents to detect microbes or lysed microbes. This can be as described above for polymerase chain reactions or for fluorescence in situ hybridization type protocols controlled by the various components of a reaction chamber to deliver a detectable signal on the test area of the substrate.

[00072] Another preferred embodiment envisioned enables food and drink safety assessment. With the origin of foodstuff becoming more difficult to track, food safety is an increasing concern. Sources of food contaminates include processing materials such as glycols, machine oils and degradation products of additives such as cyanates, nitrosamines, etc. Methods of livestock husbandry frequently include the use of steroids and antibiotics. Fish derived from the ocean are at risk of mercury contamination while farm-raised fish are in danger of pesticide contamination from runoff of surrounding areas. Finally most food is susceptible to microbial contamination. Water heavy metal levels and other contaminate levels are required for safe consumption. These and other examples are generally increasing the need for additional safety assessment beyond regulatory agencies. Incorporation of selective and nonselective reagents into the test material for specific and/or classes of contaminates provides the individual a means to verify food and drink safety in a remote or local fashion. Liquids may be assessed as described by direct application with a capillary tube or rod to the test material printed on the medium. Solids may be applied as a smear or after a simple partitioning into liquid and then applying the extract to the test area on the medium, hi this case the sample may be applied manually to the test area or by use of the reaction chamber fluidics systems. In either case, the subsequent steps of the protocol are controlled by the components of the reaction chamber to yield on the substrate a detectable signal.

[00073] An additional embodiment configures the medium to serve as an environmental and security monitor. Paints for example are often required for heavy metal including lead analyses. This is accomplished by including reagents in the test material specific for environmental contaminants, poisons and explosives. Solids may be collected by swiping surfaces or filtering air-born particles and then applying the collected sample as a smear or simple extract to the test area on the medium. Contaminants, poisons and explosives in the form of gases may be sampled by partitioning into filters with active surfaces like charcoal or into ion traps if ionic. Neutral contaminants, poisons and explosives maybe ionized first and then collected with an ion trap. Trapped molecules and particles can then be applied to the test area.

[00074] In one embodiment the portable collection housing may be manufactured with a top coating that reacts to Green House Gases. The list of anthropogenic Green House Gases as used by the IPCC TAR comprises the following:

1. Carbon dioxide (CO₂) 365 ppm 87 ppm 1.46

2. Methane (CH₄) 1 ,745 ppb 1 ,045 ppb 0.48

3. Nitrous oxide (N₂O) 314 ppb 44 ppb 0.15

4. Tetrafluoromethane Carbon tetrafluoride (CF₄) 80 ppt

5. Hexafluoroethane (C₂F_O) 3 ppt

6. Sulfur hexafluoride (SF₆) 4.2 ppt

7. HFC-23 Trifluoroethane (CHF₃) 14 pp

8. HFC- 134a 1,1,1,2-tetrafluoroethane (C₂H₂F₄) 7.5 ppt

9. HFC- 152a 1,1-Difluoroethane (C₂H₄F₂) 0.5 ppt

[00075] In one embodiment, a dye would be mixed into a gas permeable layer of an area of the portable collection housing.

[00076] In another embodiment, the following Green House Gas reacting dyes may be printed onto a top surface of a component of the portable collection housing: 4-96 mg/ml CO₂ acid reactor molecule; 1-15 mg of Blue Dye-Solvent Blue; 80 - 96% Diethyl Ketone; 1 - 5% poly methyl methacrylate; 1 - 3% methoxy propanol.

[00077] A VideoJet Excel Printer may be suitable for applying the dye to the component. The portable collection housing may be wrapped in a gas exchange proof wrapper for shipping.

[00078] In an embodiment, surface etching is used in anchoring or multiplexing the detection molecule to the colorimetric part of the molecule. For example, a capture antibody may be immobilized to polycarbonate test sites of the portable collection housing using following etch chemistry:

1.8 ml of cyclopentanone

0.2 ml of poly methyl methacrylate in methyl ethyl ketone (MEK) 100 mg/ml of a photon acid generator

11 mg/ml of blue dye (very soluble in cyclopentanone) or a dye- antibody for one of the above mentioned biomarkers.

[00079] In additional embodiments, portal interfacing electronic devices 601, such as in Fig. 3 may be employed. Portal interfacing electronic device 601 as shown has a portal 600. One or more small wells 610-610'", for receiving test samples may be located along a surface of the medium. Additional wells may be provided for test controls which in some cases may be sealed by, and assessable for interrogation through, a window. Optionally, the wells may be provided with specific reagents required for the performance of the physiological test. Required reagents may also be added to the wells 610-610'", at the time of the specific test. The wells 610-610'" may provide physical access for the applied test sample and, optionally, required reagent(s) to device. Interfaced with the wells may be one or more detection monitors (not shown), which may be the same or different between wells. Such monitors may comprise, without limitation, for example, miniature spectrophotometers, fluorescent monitors, color detection monitors, etc. Such portal interfacing electronic devices with monitors, are preferably configured to allow information to flow to any data storage within said device, as well may allow information to directly flow to the computing device to which it is attached. Exemplar computing devices, without limitation, may include personal computers, lap tops, smart phones, pda's, mainframes, servers, etc. The data stored in the memory device may change in accordance with the physiological characteristics of the test sample. The portal interfacing electronic device 601 may be provided with one or more covers for controlling the physical environment within the well. For example, each may have an associated door, or a re-sealable tab associated therewith. In operation, the portal interfacing electronic device 601 may be connected to a computer. The computer can be programmed with instructions for the physiological test protocol and may be further programmed to obtain the test results and output those test results in a form suitable for developing a diagnosis. Alternatively, the instructions may be contained in the portal interfacing electronic device itself, or may be found in both. Such device may contain in memory instructions to be enacted upon by the computing device in respect of controlling functions associated with the portal interfacing device {e.g., monitoring and/or in respect of analysis of data provided by the portal interfacing device).

STATEMENT REGARDING PREFERRED EMBODIMENTS

[00080] While the invention has been described with respect to preferred embodiments, those skilled in the art will readily appreciate that various changes and/or modifications can be made to the invention without departing from the spirit or scope of the invention as defined by the appended claims. All documents cited herein are incorporated by reference herein where appropriate for teachings of additional or alternative details, features and/or technical background. It is also noted that various embodiments of the present invention disclosed herein can be used separately, combined or selectively combined for specific applications.

REFERENCES

(1 ) Kaufman. E., and l.B Lamstcr, Crit. Rev. Oral Biol. Med., (2002) Vol.13, pp. 197-212. (2) Kennedy B. et ai, Life ScL, (2001) Vol. 69, pp. 87-99.

(3) Morahan, G., et al, Proc. Nat. Acad. ScL (1994) Vol.91, pp. 5898-5902.

Claims

CLAIMSWe claim:

1. A companion diagnostic system, comprising:

a portable collection housing, comprising:

a substrate;

a plurality of test compartments in said substrate, each of said test compartments comprising a test material, each of said test materials selectively reacting with a defined analyte, and each of said test compartments having at least one surface capable of being interrogated by a monitoring transmission;

an electronic monitoring device, comprising:

a housing having a docking portion configured to co-act with said portable collection housing;

one or more monitors in said co-acting docking portion configured to use said monitoring transmission to monitor said test compartments through said at least one surface of said test compartments in a manner to detect changes in said test compartments due to reaction between said each test material and its corresponding defined analyte;

a processor operatively connected to said one or more of monitors, said processor configured to process information pertaining to said detected changes in each of said test compartments; a memory operatively connected to said processor, said memory configured to store information pertaining to said detected changes in one or more of said test compartments, and to store algorithms relating reactions between said each test material and its corresponding defined analyte, and a physiological or chemical status; and wherein said processor is further configured to process said algorithms stored in said memory and to output information pertaining to physiological or chemical status based upon said detected changes.

2. The companion diagnostic system of claim 1, further comprises an interface configured to provide communications between said companion diagnostic system and an external processing source, using wired or wireless connections, to further process said detected changes to obtain further information pertaining to the physiological or chemical status,

3. The companion diagnostic system of claim 2, wherein said interface is provided using a wireless transceiver, a modem connection or an electric portal.

4. The companion diagnostic system of claim 2, wherein said interface is located on said portable collection housing or on said electronic monitoring device.

5. The companion diagnostic system of claim 1, wherein the portable collection housing further comprises at least one control compartment, said at least one control compartment comprising a control material for validating of a detected change in one or more of said plurality of the test compartment.

6. The companion diagnostic system of claim 1, wherein the portable collection housing has at least two different test materials in at least two of said plurality of the test compartment.

7. The companion diagnostic system of claim 1, further comprising one or more excitation sources configured to provide said interrogation by the monitoring transmission to one or more test compartments of said plurality of test compartments.

8. The companion diagnostic system of claim 1, wherein a reagent is added to at least one of said plurality of test compartments to facilitate interaction between said test material and its corresponding defined analyte.

9. The companion diagnostic device of claim 1, wherein at least one test compartment of said plurality of test compartment is a well configured to be hermetically sealed.

10. The companion diagnostic system of claim 1, wherein said defined analyte is in a biological sample provided from tissue, saliva, urine, or sputum.

11. The companion diagnostic system of claim 1, wherein said defined analyte is in a liquid form, a gas form or a solid form.

12. The companion diagnostic system of claim 1, wherein said defined analyte is a physiological marker.

13. The companion diagnostic system of claim 12, wherein said physiological marker is an insulin, a catecholamine, a triglyceride, a carbohydrate, a gene, salivary pH, a ketone, or an electrolyte.

14. The companion diagnostic system of claim 1, wherein said detected changes in said test compartments are changes in optical, electrical or magnetic properties.

15. The companion diagnostic system of claim 1, wherein at least one of said one or more monitors is a miniature spectrophotometer, a fluorescent monitor or a color detection monitors.

16. The companion diagnostic system of claim 1, wherein said portable collection housing further comprising: a base component comprising said at least one surface capable of being interrogated by said monitoring transmission; and a top component, such that said substrate with said plurality of test compartments is secured and protected between said base and top components.

17. The companion diagnostic system of claim 16, wherein said at least one surface of said base component comprises an optical window to provide said monitoring transmission.

18. A companion diagnostic device, comprising:

a component having a plurality of test compartments therein, each of said test compartments comprising a test material and being configured to receive a volume of a test sample, and each test material in said each test compartment being reactive to a defined analyte comprised in said test sample; one or more monitors coupled to said test compartments, each configured to detect changes in said test compartments related to reaction between said each test material and its corresponding defined analyte; a processor operatively connected to said one or more monitors, said processor configured to obtain information pertaining to said detected changes in each of said test compartments; and a memory operatively connected to said processor, said memory configured to store information pertaining to said detected changes in said one or more of said test compartments and to store algorithms relating reactions between said each test material and its corresponding defined analyte and physiological or chemical status, wherein said processor is further configured to send information to an external processing source.

19. The companion diagnostic device of claim 18, further comprises an interface configured to provide communications between said companion diagnostic device and said external processing source, using wired or wireless connections, to process said detected changes to obtain information pertaining to the physiological or chemical status.

20. The companion diagnostic device of claim 18, wherein said interface is provided using a wireless transceiver, a modem connection or an electric portal.

21. The companion diagnostic device of claim 20, wherein the component further comprises at least one control compartment, said at least one control compartment comprising a control material for validating of a detected change in one or more of said plurality of the test compartment.

22. The companion diagnostic device of claim 18, wherein said component comprises at least two different test materials in at least two of said plurality of the test compartment.

23. The companion diagnostic device of claim 18, further comprising one or more excitation sources configured to provide an interrogation by a monitoring transmission to one or more of said test compartments of said plurality of the test compartments.

24. The companion diagnostic device of claim 18, wherein a reagent is added to at least one of said one or more test compartments to facilitate interaction between said test material and its corresponding defined analyte.

25. The companion diagnostic device of claim 18, wherein at least one of said one or more test compartment is a well configured to be hermetically sealed.

26. The companion diagnostic device of claim 18, wherein said defined analyte is a biological sample provided from tissue, saliva, urine, or sputum.

27. The companion diagnostic device of claim 18, wherein said defined analyte is in a liquid form, a gas form or a solid form.

28. The companion diagnostic device of claim 18, wherein said defined analyte is a physiological marker.

29. The companion diagnostic device of claim 28, wherein said physiological marker is an insulin, a catecholamine, a triglyceride, a carbohydrate, a gene, salivary pH, a ketone, or an electrolyte.

30. The companion diagnostic device of claim 18, wherein said detected changes in said test compartments are changes in optical, electrical or magnetic properties.

31. The companion diagnostic device of claim 15, wherein at least one of said one or more of monitors is a miniature spectrophotometer, a fluorescent monitor or a color detection monitors.

32. A method, comprising: locating one or more test compartments of a plurality of test compartments in a companion diagnostic device, each test compartment comprising a test material reactive to a defined analyte; detecting changes in said one or more test compartments related to reaction of said test material with its corresponding defined analyte using one or more monitors comprised in said companion diagnostic device, each of said one or more monitors being coupled to corresponding one of said one or more test compartments; storing information pertaining to said detected changes in said one or more of said test compartments in a memory of said companion diagnostic device; and transmitting wirelessly said information pertaining to said detected changes in each of said one or more test compartments to an external processing source.

33. The method of claim 32, further comprising : processing information pertaining to said detected changes in each of said one or more test compartments using algorithms relating reactions between said each test material and its corresponding defined analyte stored in said memory and providing information pertaining to physiological or chemical status based upon the results of said algorithms by a processor of said companion diagnostic device operatively connected to said one or more of monitors.