WO2002037940A2

WO2002037940A2 - System and method for biological sample analysis and adaptive diagnostic device creation

Info

Publication number: WO2002037940A2
Application number: PCT/US2001/051016
Authority: WO
Inventors: Daniel Hawkins; Douglas R. Nunes
Original assignee: Pluvita Corporation
Priority date: 2000-10-20
Filing date: 2001-10-19
Publication date: 2002-05-16
Also published as: AU2002237743A1

Abstract

The present invention is a system and method for creating patient-specific testing of a biological sample. A patients's biological sample is tested; the results are communicated to an analysis processor that assesses test results and develops a diagnosis using a biomedical database containing the patient's prior tests as well as clinical data. An interested party studies the diagnosis and oders a diagnostic chip for performing customized testing of a saved biological sample, performing genomic, prteomic and other analyses including sugar and hormonal levels. These test results are used for further diagnosis and for creating a proactive course of action for the patient. Genomic and prteomic analyses assess DNA and RNA patterns which provide insight to potential current and future healht abnormalities. In a preferred embodiment, a network such as an Internet, Intranet and wireless network link system components. Additionally, access to data with privacy protection is given legitimate subscribers.

Description

System and Method for Biological Sample

Analysis and Adaptive Diagnostic Device

Creation

Cross reference to Related Applications

[01] This application is a continuation in part of U.S. Application No.

09/498,804, filed February 7, 2000, now pending.

[02] Priority is claimed under 37 C.F.R. 120. This application claims the benefit of U.S. Provisional Application 60/247,669. Application No. 60/247,669 claims benefit of U.S. Provisional Application No. 60/242,130 filed October 20, 2000.

[03] The 60/247,669 provisional application, the 60/242,130 provisional application and the 09/498,804 non-provisional application are incorporated by reference herein, in their entirety, for all purposes.

Field of the Invention

[04] This invention relates generally to biological testing and analysis. More particularly the present invention comprises a system and method for analyzing a biological sample and using the sample's analysis to create customized analysis devices for subsequent research and diagnosis.

Background of the Invention

[05] Testing for a wide variety of genetic conditions has now dramatically increased with the continued mapping of the human genome. Other types of molecules, including without limitation RNA, DNA, and proteins, are being used to create individual profiles for patients and for diagnosis of medical conditions. Also, other researchers and medical practitioners have the ability to perform biological testing of patients and to rapidly determine if certain medical conditions are present or might possibly be present in the future. To assist in the diagnosis and predictive analysis, diagnostic devices to perform the type of testing noted above are being developed at an ever more rapid pace. For example, diagnostic chips such as those manufactured by CombiMatrix are now being developed with one million probes in one square centimeter. These probes, referred to as micro arrays, comprise affinity probes, that is, probes that are used to test for specific genetic or biological conditions, and may be placed on a single diagnostic chip. Thus, such a diagnostic chip may comprise test sites for a variety of physiological conditions. Therefore, in any one diagnostic chip, a medical professional or researcher could assess the presence of genes, RNA, DNA, and proteins which may be indicative of existing physical conditions or those conditions to which a patient may be susceptible at some time in the future.

[06] In the case of the CombiMatrix biochip system, a series of "Virtual

Reactors" which are small chemical vessels that are individually separated from one another are used to synthesize DNA, peptides and other chemicals on the diagnostic chip. The presence of these various chemicals are indicative of a particular physical condition.

[07] Research is rapidly progressing as well in other diagnostic device areas in for example, and without limitation, DNA chips from, for example, Affymetrix, and RNA and protein chips available from, for example, Ciphergen which will allow genes, their expression and proteins to be identified on a particular chip. Further Micro Arrays such as those of Nycomed Amersham / Amersham Pharmacia Biotec allow gene detection via very small detectors, thereby reducing the size of the overall detector package. Further, advances in fiber optic probes for example by lllumina, Inc. now allow 250,000 discrete sensors to fit on a probe the diameter of a pin head for proteomic studies. For purposes of this application, such chips, arrays and probes are referred generally as "Analysis Devices." Other similar technologies are available from PE Biosystems, Nycomed Amersham, Nanogen, Hyseq, Caliper, Clinical Micro Sensors. Specifically, Nanogen possesses electronic concentration and hybridization technology that is suited to the present invention. Such technology is embodied in a disposable cartridge comprising a semiconductor microchip and electrical and fluidic connections for use in analysis equipment. The following U.S. patents discuss this technology, the contents of the below listed patents are incorporated herein by reference in their entirety:

[08] U.S. Patent No. 6,099,803 "Advanced active electronic devices for molecular biological analysis and diagnostics "

[09] U.S. Patent No. 6,071 ,394 "Channel-less separation of bioparticles on a bioelectronic chip by dielectrophoresis "

[10] U.S. Patent No. 6,068,818 "Multicomponent devices for molecular biological analysis and diagnostics"

[11] U.S. Patent No. 6,051 ,380 "Methods and Procedures for Molecular

Biological Analysis and Diagnostics"

[12] U.S. Patent No. 6,048,690 "Methods for Electronic Fluorescent

Perturbation for Analysis and Electronic Perturbation Catalysis for Synthesis"

[13] U.S. Patent No. 5,849,486 "Methods For Hybridization Analysis Utilizing

Electronically Controlled Hybridization"

[14] U.S. Patent No. 5,605,662 "Active Programmable Electronic Devices for

Molecular Biological Analysis and Diagnostics"

[15] Other analysis techniques also exist and are suitable for use with the present inventions. For example, patent no. 6,045,676 was issues to Mathies et al. for a "Electrochemical detector integrated on microfabricated capillary electrophoreses chips" for use in detecting molecules. The contents of this patent are incorporated herein by reference in its entirety. [16] The LabCD manufactured by Gamera Bioscience Corp. also represents technology that is suitable to sample preparation that would find use in the present invention The capabilities and format of the LabCD are describe in U.S. Patent No. 6,063,589 which is incorporated herein by reference in its entirety. These analysis devices can then be used to determine if the particular gene in question is working properly with other genes, or if other biological factors are present which may be indicative of certain medical conditions.

[17] The trend therefore is to continue to map human genes and to develop understanding regarding how they are expressed in a body or in body fluids (for example, blood, urine, saliva, sperm, sweat and milk).

[18] Of importance to the present invention, hoevere, is that customized diagnostic chips may be created. The diagnostic chips are keyed to the detection of particular molecules that in turn are used in the diagnosis of particular physical conditions or those conditions to which a patient may be susceptible at some time in the future. In some cases, the customized diagnostic chips may be created on very short notice. Rapid fabrication, while important in the context of the present invention, is not meant as a limitation but is illustrative only of what is available in the present state of the art.

[19] Other diagnostic chips are equally suitable for such testing. For example biochip systems from Affymetrix, Millennium, and Incyte are but a few examples of the types of products that are available to perform the type of genetic and proteomic testing discussed herein.

[20] Further, such diagnostic chips are currently the fastest and most efficient method for analyzing DNA permitting a medical practitioner to simultaneously perform literally hundreds of tests on a biological sample of genetic material.

[21] Collection of test data and analyses, stored in an electronic database, remotely accessible by caregivers and researchers is desirable. For example, US Patent 5,704,366 to Tacklind, et al., describes a system for monitoring and reporting medical information to a remote location. Analysis is made for each patient and a report transmitted to a requesting health care provider on demand.

[22] Systems that remotely interact with the patient to monitor and direct the patient to a course of action are also known. US Patent 5,827,180 to Goodman describes a method and system for a health network comprising a facility, operated by a party other than the patient or health care provider, for collecting and routing information pertaining to the health care of a patient to the patient and the health care provider. The facility receives treatment instructions from the health care provider specific to a patient. A messaging device that is part of the system prompts the patient to measure and enter relevant physiological data as dictated by the treatment instructions. Based on the measured physiological data, messages are displayed on the message device advising the patient of a specific course of treatment.

[23] Personal data storage devices that interact with remote health assessment systems are also know. US Patent 6,055,512 to Dean, et al. describes a system that allows a user to insert a personal data storage medium such as a smart card into a service terminal facility. The service terminal would be available at a public access location. The personalized data include user information such as contacts, personal details, medical data and personal interest information. The service terminal interacts with a remote database and other resources to service the user regarding health needs.

[24] US Patent 5,935,060 to lliff describes a system and method for providing computerized, knowledge-based medical diagnostic advice. The medical advice and diagnosis are provided to the general public over a network such as the Internet, or can be provided in a stand-alone mode.

[25] US Patent 5,878,746 to Lemelson, et al. describes a system and method whereby medical examinations and evaluations of body fluid sample, tissues, structure, appearance, imaging results, etc. may be automatically made, recorded and/or compared to past records of such examinations for the purpose of diagnosis and early treatment of disease.

[26] While these inventions describe computerized methods of diagnosis, they do not address the production and use of customized devices. What would be truly useful is a system and method for diagnosing the presence or potential presence of a medical condition via a sequence of analyses overtime, using changes and trends as a tool in constructing customized follow up testing. Such a system would allow a biological sample to be taken and partially preserved, and to have that sample automatically analyzed.

[27] Subsequent to the initial analysis, a customized, patient-specific diagnostic article or PSDA could then be rapidly developed to more precisely identify any particular medical conditions that might afflict a patient or to which patient might be susceptible later in life. Further, a proactive course of action can be charted for the patient

Summary of the Invention

[28] It is therefore an objective of the present invention to conduct testing on a biological sample and to use the analysis of that sample to create a subsequent patient-specific test.

[29] It is a further objective of the present invention to conduct testing on a biological sample and to use the analysis of that sample to subsequently produce rapidly a customized PSDA for subsequent patient-specific testing.

[30] It is still another objective of the present invention to allow researchers and medical practitioners to rapidly produce customized analysis articles in response to biological data analyzed from an initial reading of a biological sample test.

[31] It is yet another objective of the present invention to create a PSDA based upon evaluating database information.

[32] It is still another objective of the present invention to rapidly create a

PSDA device comprising a variety of assays in order to diagnose the presence of a particular health condition.

[33] It is yet another objective of the present invention to establish a database of biological information and sample analyses in a rapid fashion from both generalized and specific diagnostic chips.

[34] These and other objectives of the present invention will become apparent from a review of the specification that follows.

[35] The present invention comprises a system and method for rapidly making customized, PSDAs and for a health diagnosis based on a first testing of a biological sample taken from a patient and then creating a subsequent patient-specific test from an analysis of the first test results. Additionally, the present creates a treatment strategy advising the patient on a course of action, sources of medical care and intervention based in part on performing diagnostic testing and comparison of prior results gleaned from standard and customized testing of the patient.

[36] In a preferred embodiment of the present invention, standard diagnostic chips along with PSDAs for follow up testing are used in conjunction with an analysis device. The PSDAs are keyed to the detection of particular molecules that in turn are used in the diagnosis of particular physical conditions or those conditions to which a patient may be susceptible at some time in the future. In some cases, the customized diagnostic chips may be created on very short notice. Rapid fabrication, while important in the context of the present invention, is not meant as a limitation but is illustrative only of what is available in the present state of the art.

[37] A patient provides a biological sample (which may be saliva, blood, urine, sperm or other fluid) that is tested by a diagnostic chip. An analysis device reads the diagnostic chip results at a health care provider location. The data read by the analysis device is transmitted to an analysis processor that reads the information, categorizes it, analyzes it, and stores the information in a wide variety of ways known in the art of bioinformatics.

[38] The analysis processor uses a biomedical database to arrive at a diagnosis. The database comprising patient bioinformatics and clinical data from multiple health sources along with results received from the analysis device. The biomedical database is also available, with appropriate security and privacy filters in place, to researchers, medical practitioners, and pharmaceutical companies for analysis of the bioinformatics and clinical data contained therein.

[39] Based upon the analysis and diagnosis from the analysis processor, the patient's health care provider (HCP) or an intervening "interested party" orders any number of new, specialized or general diagnostic chips PSDAs from a diagnostic chip manufacturer. The new diagnostic chips, which are adaptive diagnostic devices, are forwarded to the patient or to the HCP. The new diagnostic article, hereinafter referred to as "patient specific diagnostic article" and comprises, without limitation, chips, arrays, micro-capillary devices and other devices know in the art that are capable of detecting the present of small molecules" or "PSDA", test remaining biological sample from the patient. The patient may be required to provide a new biological sample under some conditions.

[40] For purposes of this application the term "interested party" includes a person who orders diagnostic chips or PSDAs on behalf of the patient. Additionally, "interested party" having access to the analysis processor's output and/or database, with appropriate privacy safeguards in place, include a researcher, research organization, health organization, governmental agency, health care product marketer and drug company. This enumeration of "interested party" is not meant as a limitation and any legitimate user of health and biomedical data would be an "interested party".

[41] Further, for purposes of this application the term "PSDA" is a diagnostic article that is designed to analyze a specific patient's biological sample for very specific biological conditions.

[42] The design of the PSDA is driven by a prior analysis and diagnosis of any patient health condition. This PSDA allows a clinical assessment of a health condition at a much finer level. Further, a proactive course of action can be charted for the patient given a narrower assessment of the patient's health and health risks

[43] In the preferred embodiment of the present invention, the patient's biological sample, a "body fluid" sample, undergoes subsequent, customized testing. This subsequent testing is narrower and more specific than the original, standard testing. Specific follow up testing is based on analysis and diagnosis generated from the original testing of the patient's biological sample. It is designed to be "health condition" specific. For purposes of this application, "health condition" includes disease, health conditions, health exceptions, health abnormalities, a propensity to develop a disease or health exception in the future, a prior disease or health exception, and out of range conditions for certain biological and physiological measurements.

[44] Subsequent testing, reading and results transmission is done at the original testing location, other locations accessible to the patient such as a kiosk or a lab, or where the patient's biological sample is accessible. A testing device at the patient's home is also within the scope of the present invention. The "follow up location" is the generic term used in the present application to mean the site where additional subsequent testing of the patient's biological sample is performed, read and transmitted.

[45] Information from the PSDAs may include DNA, RNA, hormonal level, sugar level, genomic information, or proteomic information. If multiple PSDAs are used, they may be read individually or simultaneously on the analysis device.

[46] Thus the location of the analysis device should be read broadly and without limitation to an HCP office. That information is then communicated to an analysis processor. Preferably, but without limitation, the method of communicating is done over a network such as the Internet, an Intranet, or other wired and wireless network suitable for the transmission. Security and privacy measures such as, but without limitation, encryption of the data may be used for such transmission.

[47] For purposes of this application, the bioinformatics data comprises RNA,

DNA, hormonal, sugar, proteomic and genomic information. These data are not meant as a limitation as other data may also be useful. Collectively, these data are referred to herein as "Biological Information."

[48] An interested party and/or HCP subscribe to the database, paying a fee for that subscription. The interested party or HCP receives the results from the analysis processor. Upon viewing information contained in the patient's bioinformatics and the biomedical database and comparing the analysis processor's results with the biomedical database, the HCP or interested party determines that a particular combination of assays might be particularly efficacious. An electronic request is made for a PSDA be constructed that has the desired assays and particular characteristics for testing precisely those conditions, or combination of conditions of interest.

[49] Thereafter, the PSDA is created and sent back to a follow up location.

Since a relatively small amount of biological sample is required for any particular diagnostic chip, residual biological sample from the same batch that gave rise to the initial test results is then used. The PSDA tests the sample. This same PSDA, or a PSDA with similar assays can be used over time for the specific patient. [50] Any such diagnostic article (standard or patient-specific) generated has a particular identifier associated with it linking it to the patient and the original biological sample. In subsequent testing, not only is the biological information from the diagnostic chip reported but the specific identifier of the diagnostic chip is reported as well. In this fashion the information that is ultimately gleaned from the diagnostic chip by the analysis processor can be directly reported to the party that requested the PSDA creation in the first instance as well as filed in the database of the bioinformatics information. In this fashion a very rapid prototyping of a PSDA can take place and specifically-targeted biological information can be reported back to the HCP and/or interested party requesting it.

[51] In this biological testing paradigm, revenue is generated from several sources. First, fees are developed from the testing, analysis and diagnosis of the biological samples read by the analysis device. Patients subsequently pay fees to have the analysis results reported back to them. A fee may be collected for subsequent access a patient's biological testing service when a report requires that baseline information. In this manner, expression profiles may be compared. Such expression profile comparison is described in patent application serial no. 09/498,804 which claims the priority of Serial No. 60/158,795, filed 10/12/99 and from Serial No. 60/150,974, filed 08/27/99 all of which are incorporated herein by reference in their entirety for all purposes.

[52] Researchers, medical practitioners, and pharmaceutical companies will pay licensing fees in order to access the database of biological information created. This information is entered into the database in an anonymous fashion so specific data cannot be associated with any patient.

[53] Further, when an interested party requires a PSDA to be created, additional fees may be charged to create the PSDA in a rapid fashion. Subsequent reporting of resultant analysis, whether directly via the analysis processor or in some other direct or indirect communication route, is another source of fees.

[54] Sample analyses in research databases are generated in a variety of ways. Sample analyses from diagnostic chips that are submitted by patients for analysis are stored in the database in an anonymous fashion. In addition, samples can be collected from patients during regular visits to health care provider offices with patient permission. The results, after analysis, are submitted to the database of the present invention in an anonymous fashion as described above. Further, when follow-up visits are scheduled, the PSDAs can be used to collect samples form the same patient during any follow up visit.

[55] When a patient is hospitalized, an opportunity is presented for a series of both standard and PSDA assays to take place. Again, when a patient enters a hospital for any extended stay, a sample may be obtained from the patient and analyzed. If a PSDA is warranted, such a PSDA can be developed and a biological sample from the same patient may be administered to the PSDA so that the specialized analysis can be conducted.

[56] Patients can be advised of the results of the analysis tests. Additionally, the results can simply be stored in an anonymous fashion for research purposes.

[57] Another source for database population is from those entering the prison system. For example, in the Commonwealth of Virginia, any convicted felon must have a blood sample take for DNA purposes. This sample could also be used as a deposit to a diagnostic chip and the results deposited in the database. Obviously the prison population offers yet other opportunities for follow-up testing and PSDA development, as does the repository of biological samples being assembled for military DNA analysis purposes.

[58] A further application of the present invention is for diagnosing patients who feel that they may be victims of bio-terrorism. For example, there are assays to determine the presence of bio-terrorism agents. However, once an individual is exposed to an agent, the individual will produce antibodies indicative of exposure to a specific agent that can also be detected using special purpose analysis chips.

[59] Thus the present invention is also used to create rapidly a chip that can determine the presence or absence of antibodies that would result from an individual's immune response to exposure to certain biological agents. The rapid production of diagnostic chips keyed to the individual that test for multiple antibodies indicative of exposure to a variety of biological agents is therefore considered within the scope of the present invention.

[60] Thus, for example, an individual working in the US Congress would have a personal test chip ordered having assays for antibodies for, for example, anthrax, produced on a specialized chip. The person then deposits a biological sample on the diagnostic chip, submits the chip for reading and is rapidly advised of the results using the system of the present invention. A test could be conducted each week or on an as needed basis depending on the threat.

[61] Still another application of the present invention is in the field of infectious diseases generally. A sin the case of bio-terrorism where specific agents are suspected, so too does the present invention find use with any infectious disease. Patients who feel they have been exposed to certain diseases, or those who simply are not feeling well for any reason can submit a biological sample for analysis on a customized chip and rapidly receive the results of the analysis with recommendations for curative measures.

[62]

Brief Description of the Figures

[63] Figure 1 illustrates the overall health care model of the present invention [64] Figure 2 illustrates the overall architecture of the present invention.

Detailed Description of the Invention

[65] The present invention takes a biological sample from a patient. A diagnostic chip tests the sample. Test results comprising biological information are read by an analysis device and the results transmitted by an analysis device to an analysis processor. The analysis processor analyzes the information, stores biological information of ht patient in a biomedical database and, using the bionformatics information along with clinical data stored in the biomedical database, derives a diagnosis of a health condition for the patient.

[66] An interested party and/or a HCP review the diagnosis and analysis. A revised test strategy is created to focus on the diagnosed health abnormality. In the preferred embodiment of the present invention, the HCP and/or interested party creates a patient-specific test by ordering one or more PSDAs to conduct narrower, more specific tests on the patient's biological sample. This will be referred to as "patient-specific biological testing". After performing patient-specific biological testing, the analysis device at a follow up location reads and transmits the results to the analysis processor. Note that the follow up location may be the original test location, but need not be. This PSDA, or ones with similar patient-specific assays are used for future diagnostic and wellness check ups for the specific patient.

[67] The analysis processor updates the biomedical database, analyzes the customized test results and develops a revised diagnosis. The HCP and/or interested party reviews the revised diagnosis and test results analysis, employs Bioinformatics Tools at her disposal and develops a treatment plan or course of action for the patient.

[68] Additionally, the system provides other interested parties, such as researchers, drug companies, government agencies and the like access to the biomedical database. The information made available to these other interested parties is filtered so as to protect the patient's privacy and security.

[69] Referring first to Figure 1 , the overall health care model of the present invention is illustrated. A patient 10 proceeds to a HCP office and gives a biological sample that is tested by a diagnostic article. An analysis device 12 reads the results. The results are read at the HCP location 12 and communicated over a network to an organization comprising a analysis processor 14, which has a variety of other health care related tasks associated with it. There will be other situations where the biological sample is taken from the patient at some other location 11 such as a clinic or hospital in lieu of the patient providing a biological sample at the HCP location.

[70] For example, analysis processor comprises software for analyzing the results of the analysis from the diagnostic devices which read information from the diagnostic article. It further comprises a link to a database 15 comprising patient and clinical information 15A relating to health abnormalities; expression profiles for health abnormalities; and various patient profiles. The database 15 also comprises contact information with researchers and doctors 15B so that information can be received and disseminated according to privacy policies and permissions from patients. The database further comprises a compendium of disease management tools 15C that provide intervention information, course of action roadmaps and recommendations to both clinicians and patients regarding the outcome of the analysis. Further, and without limitation to other database additions, the database 15 comprises a diagnostic article order catalogue 15D that allows healthcare practitioners and other interested parties to order PSDAs, depending on the assay desired, from various sources of such diagnostic chips.

[71] The HCP and/or interested party will use the disease management tools

15C to provide intervention tasks, as well as develop courses of action to the patient on an individualized basis. [72] For purposes of this application, the method of "communicating" includes, without limitation: digitally communicating by network (wired or wireless); communicating by physical delivery such as letter or delivery service; orally communicating in person or by device such as the telephone; and digitally communicating data within a processor. The preferred method of the present invention of communicating by network is by Intranet, Internet and wireless network.

[73] The patient 10 registers, directly or via a HCP, with the server organization 14 of the present invention to provide patient data and contact information. Personal information is kept strictly confidential.

[74] The information from the initial testing, along with confidentially secured personal information, is stored at a database associated with an analysis processor 14 in a database. Using various bioinformatics tools 16, the database can be accessed in a highly flexible fashion by a subscription user, such as a researcher, pharmaceutical company and medical practitioner 18 (i.e., an "interested party"). In the event that such interested party 18 desires certain specific combinations of biological testing done based on information from the bioinformatics 16 search, the interested party has the opportunity to create a PSDA 20 which comprises specific assays desired by the interested party 18.

[75] The PSDA is created and, in a preferred embodiment, sent to the original

HCP location 12, another facility or the patient 10, within a short period of time, such as 24 hours. This way residual biological material from the patient 10 can be used on the PSDA 20 for subsequent testing without concern of sample spoilage.

[76] The PSDA 20 tests a portion of the residual biological sample. Results from the PSDA are read at the HCP location 12 by the analysis device, which transmits the results to the server organization 14 and specifically reported to the interested party 18. In some cases the reporting of information may also go to other interested parties such as university, industry and government researchers and the like. Alternatively, it will also be within the scope of the present invention to report the data to others as designated by the interested party.

[77] Referring to Figure 2, the overall architecture of the present invention according to one embodiment is illustrated. In this instance, a HCP testing device 30 is used to obtain, for example and without limitation, sugar information 32, DNA information 34, protein information 36 and hormonal information via individual diagnostic chip devices. It should be noted that each diagnostic chip has multiple assays in order to assess the presence of specific molecules. This is not meant as a limitation since single purpose diagnostic chip may be used as well.

[78] Biological samples 38, 40, and 42 are input to and tested by the diagnostic chip devices. The analysis device 30 then reads results. This is not meant as a limitation however. For example, the analysis device may be the device into which a biological sample is deposited and read without the need for a separate diagnostic article. Thus this figure should be read broadly and not to preclude a unitary reader/analysis device. In an alternate embodiment, the sample may be input directly to a reader adapted to receive the biological sample, rather that onto a diagnostic chip and thence into a reader.

[79] In this instance, the health care provider analysis device 30 is a telephonic instrument, although this is not meant as a limitation. The diagnostic chip reader could be a specific device for that purpose, a personal computer or, just as easily, it could be an interface to a wired or wireless device.

[80] Information read from diagnostic chips 32, 34, 36 are reported over network 46 to an analysis processor 14. In one embodiment of the present invention, the telephonic analysis devise 30 has wireless capability, communicating via transceiver 44.

[81] Analysis processor 14 performs the appropriate analysis and stores information associated with the patient biological sample. An interested party, such as a researcher, medical practitioner, or pharmaceutical firms 18 interacts with the analysis processor 14 using bioinformatics processing to mine data stored in the database 15.

[82] Based upon information gleaned from the database 15, interested party

18 requests a PSDA be created for further testing. In that instance, interested party 18 communicates with a diagnostic chip manufacturer 20 over a network 46 providing to the diagnostic chip manufacturer with the desired PSDA characteristics. Thereafter, the diagnostic chip manufacturer performs a rapid fabrication of a PSDA to the specification desired by interested party 18 and sends that PSDA to a designated location, for example the original location at which the sample was taken 30, for subsequent testing. Thereafter, a HCP using the biological sample previously collected or a new sample as required places that biological sample on the PSDA from diagnostic chip manufacturer 20.

[83] Information is then read at some HCP location such as the original location at which the sample was taken 30. Results are conveyed via a wired or wireless mode over network 46 to the analysis processor 14. In this instance, however, the information is earmarked not only for storage in the database 15, but for transmission to the interested party 18 that requested the original diagnostic chip (standard or patient-specific) to be manufactured.

[84] As noted above, revenue is generated in this model from testing done at

HCP location 30, from revenue generated from the patient from whom the biological sample is taken. The patient would receive feedback on the analysis results. Revenue is also generated from interested parties 18 subscribe to the database 15 and/or those who pay additional fees to have the PSDA manufactured by the diagnostic chip manufacturer 20. [85] The system of the present invention will be a tremendous boon to researchers and medical practitioners alike. While clearly this approach and system is of interest to the researcher in genetics and medicine, this approach can also be used to analyze potential markers for disease, discovering potential drug targets, as well as for diagnostic testing described above. Using the diagnostic chip devices as described together with rapidly produced PSDAs, an invaluable database can be populated and created that will serve the needs of researchers and medical practitioners alike.

[86] Biological information, such as genomic, proteomic, hormonal, sugar,

DNA and RNA, provide certain keys as to disease and health abnormalities existing and potentially in the future. Not only can a HCP treat revealed disease, a proactive plan of treatment, future health assessment and risks and suggested life style changes can be made.

[87] A system and method for creating customized biological testing has now been illustrated. It will be appreciated by those skilled in the art that other architectures that give rise to this PSDA development and biological testing are possible without departing from the scope of the invention as disclosed. Further, while reference has been made to the rapid prototyping and delivery of PSDAs for specialized analysis, this is but one model of how this research effort would be conducted. For certain technologies, and sample situations, the rapid prototyping may neither possible nor desirable. In those cases, a PSDA or analysis device will be created but not necessarily on an emergency or expedited basis. The essence of the present invention is to analyze the various molecules present (DNA, proteins etc) and, where indicated, create a PSDA to be used with the same person or biological sample to obtain further correlations to medical conditions.

Claims

im:

[d] A method for creating patient-specific biological testing comprising: a patient submitting a biological sample at a health care provider location; a diagnostic article testing a portion of the biological sample; an analysis device reading results from the diagnostic article; the analysis device communicating the results to an analysis processor over a network; the analysis processor receiving the results and assessing the results for a health condition; the analysis processor diagnosing a health condition for the patient; the analysis processor communicating the health condition of the patient to a health care provider over the network; a patient-specific diagnostic article (PSDA) conducting a new test using a biological sample from the patient as input ;

an analysis device at a follow up location reading results from the PSDA;

the analysis device communicating the results to an analysis processor over the network; the analysis processor diagnosing a revised health condition; and the analysis processor communicating the revised health condition to at least one of the group comprising an interested party, the health care provider and the patient over the network.

[c2] The method of claim [d] further comprising the analysis processor retrieving information regarding the health condition from a biomedical database.

[c3] The method of claim [d] further comprising: the interested party ordering a PSDA from a diagnostic article manufacturer; and the diagnostic chip manufacturer producing and shipping the PSDA to follow up location wherein the conducting the new test using the biological sample from the patient as input to the PSDA is done at the follow up location.

[c4] The method of claim [c3] further comprising the health care provider storing a remaining portion of the biological sample wherein the remaining portion of the biological sample is available in the conducting the new test at the follow up location.

[c5] The method of claim [c2] further comprising the analysis processor storing biological data for the patient in the biomedical database and wherein the analysis processor diagnosing a condition further comprises comparing stored bioinformatics information for the patient with bioinformatics information in the results of the new test.

[c6] The method of claim [d] wherein the biological sample comprises proteomic information.

[c7] The method of claim [d] wherein the biological sample comprises genomic information.

[cδ] The method of claim [c7] wherein the genomic information comprises one or more from the group consisting of DNA and RNA.

[c9] The method of claim [d] wherein the biological sample comprises information concerning sugars in the biological sample.

[c10] The method of claim [d] wherein the biological sample comprises information concerning hormonal levels in the biological sample.

[d 1] The method of claim [d] wherein the analysis processor further comprises creating a proactive treatment plan to prevent and ameliorate potential health condition.

[c12] The method of claim [d] further comprises reminding the patient on a periodic basis of the need to perform intervention tasks relating to the diagnosed health condition.

[c13] The method of claim [c2] wherein the database is a patient bioinformatics and clinical information database.

[c14] The method of claim [c13] wherein the analysis processor communicating further comprises accessing contact information for researchers and health care provider's database.

[d 5] The method of claim [c13] wherein the analysis processor diagnosing a health condition further comprises accessing disease management tools database.

[d 6] The method of claim [d 3] wherein the analysis processor diagnosing a health condition further comprises interfacing to an on line diagnostic chip ordering catalogue.

[c17] The method of claim [c2] wherein the analysis processor diagnosing a health condition further comprises researching human disease and biological conditions in the biomedical database using the bioinformatics tools.

[d 8] The method of claim [c12] further comprising protecting privacy of the patient.

[c19] The method of claim [c12] further comprising compiling biological information from the patients undergoing biological testing and compiling clinical information.

[c20] The method of claim [c19] further comprising compiling biological information, from populations other than patients undergoing biological testing, in the database

[c21] A system for creating patient-specific biological testing comprising: a biological sample submitted by a patient for testing; a diagnostic article adapted for testing a biological sample and storage for storing the results of the testing; an first analysis device comprising a diagnostic article reader for reading the results from the diagnostic article and logic for communicating the results over a network; an analysis processor comprising logic for receiving the results over the network, logic for diagnosing a health condition for the patient, and logic for communicating the health condition to a health care provider; a PSDA adapted for testing the biological sample and storage for storing revised results from the testing; an second analysis device located at a follow up location, said second analysis device comprising a diagnostic article reader for reading the revised results and logic for communicating the revised results over a network to the analysis processor; the analysis processor further comprising logic for receiving the revised results, logic for diagnosing a revised health condition, and logic for communicating the revised health condition to at least one of the group comprising an interested party, the health care provider and the patient.

[c22] The system of claim [c21] wherein the analysis processor further comprising logic for retrieving information regarding the health condition from a biomedical database.

[c23] The system of claim [c21] further comprising logic for ordering a diagnostic chip by an interested part.

[c24] The system of claim [c22] wherein the analysis processor further comprises: logic for storing biological data for the patient in the biomedical database; and logic for comparing stored biological information for the patient with biological information from the revised results.

[c25] The system of claim [c21] wherein the biological sample comprises proteomic information.

[c26] The system of claim [c21] wherein the biological sample comprises genomic information.

[c27] The system of claim [c26] wherein the genomic information comprises one or more from the group consisting of DNA and RNA.

[c28] The system of claim [c21] wherein the biological sample comprises information concerning sugars in the biological sample.

[c29] The system of claim [c21] wherein the biological sample comprises information concerning hormones in the biological sample.

[c30] The system of claim [c21] wherein the analysis processor further comprises logic for creating a proactive treatment plan to prevent and ameliorate potential health condition.

[c31] The system of claim [c21] wherein the analysis processor further comprises logic for reminding the patient of the need to perform intervention tasks on a periodic basis.

[c32] The system of claim [c21] wherein the database comprises a patient bioinformatics information and clinical information.

[c33] The system of claim [c32] wherein the database further comprises contact information for researchers and health care providers.

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[c34] The system of claim [c32] wherein the database further comprises logic for accessing disease management tools.

[c35] The system of claim [c32] wherein the database further comprises an interface for on line diagnostic article ordering.

[c36] The system of claim [c21] wherein the database further comprises human disease and biological condition data and wherein the analysis processor and the database comprise logic for permitting access to the data by a researcher.

[c37] The system of claim [c32] further comprising a security system for protecting privacy of the patient.

[c38] The system of claim [c32] wherein the database further comprises logic for compiling biological information from patients undergoing biological testing; and logic for compiling clinical information.

[c39] The system of claim [c38] wherein the database further comprises logic for compiling biological information from populations other than patients undergoing biological testing.