Title of Invention: System and Method for Genomic and Proteomic Animal Disease Assessment via Expression Profile Comparison
Field of the invention This invention relates generally to genomic or proteomic testing. More particularly this invention provides a system and method for measuring the expression of the genome and other biological factors over a network, which could lead to disease prediction and prevention in animals. Background Of The invention Mapping of the animal genome has been in process by both the government and private industry for the past ten years. At the same time new research has lead to specific tests for conditions that are evidenced by genes and certain gene expressions. Further the methods for the detecting of genomic, proteomic and other biological factors have dramatically improved. Similarly, genetic engineering and research is extremely active in the animal marketplace where both plants and animals are the subject of genetic engineering and commercialization. Research is rapidly progressing on 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: U.S. Patent No. 6,099,803 "Advanced active electronic devices for molecular biological analysis and diagnostics " U.S. Patent No. 6,071 ,394 "Channel-less separation of bioparticles on a bioelectronic chip by dielectrophoresis " U.S. Patent No. 6,068,818 "Multicomponent devices for molecular biological analysis and diagnostics" U.S. Patent No. 6,051 ,380 "Methods and Procedures for Molecular Biological Analysis and Diagnostics" U.S. Patent No. 6,048,690 "Methods for Electronic Fluorescent Perturbation for Analysis and Electronic Perturbation Catalysis for Synthesis " U.S. Patent No. 5,849,486 "Methods For Hybridization Analysis Utilizing Electronically Controlled Hybridization" U.S. Patent No. 5,605,662 "Active Programmable Electronic Devices for Molecular Biological Analysis and Diagnostics" 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. 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 described 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. These devices can also be used to map animal genome 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). For example it would be very useful for pet owners, ranchers, people caring for animals, but not limited to such individuals, (responsible individuals) to obtain an animal's expression profile of an animal's genes so that it can be used for assessing an animal's normal versus abnormal condition states. If, for example, a responsible individual knows the difference between the normal expression of genes and the deviations from normal which are statistically important, that could prevent for example, skeletal malformations, dysplasia, heart disease, and other conditions that are reflected by a mutated gene. It would also be useful if a responsible individual would have the expression profile which would be a baseline or standard, for subsequent comparison of normal versus abnormal conditions. Since household pets constitute a billion dollar industry requiring disease assessment and cure such profiles become useful for pet owners. Summary Of The Invention It is therefore an objective of the present invention to produce a specific tool in the form of a genophone, a computer with associated reader, and a standalone station which will read an analysis device which will, in turn, measure the expression of genes and other biological parameters in the blood, urine, saliva, sperm, sweat and milk of animals. It is a further objective of the present invention to establish a baseline of the gene expression, and expression of other biological actors such as, but without limitation, small molecules, peptides, and metabolites of an animal when the animal is healthy.
It is yet another objective of the present invention to create a standard expression map for animals that are to be monitored using an analysis device so that expression of every gene and other biological factors can be identified and compared with previous samples from the same monitored animal. It is a further objective of the present invention to characterize gene expression or other biological indicators at a disease stage for comparison to a "standard" expression profile for animals. It is yet another objective of the present invention to characterize the expression of an animal's individual expression profiles periodically during the life span of an animal to be monitored and to store that data on a dedicated site for subsequent review and comparison. It is a further objective of the present invention to have an individual analysis device read at a convenient site, at a site other than a laboratory, in public places, and in hand held devices and have that information transmitted to a central analysis site over a network which could be the Internet, an intranet, a wireless network or some other network able to transmit data. It is still another objective of the present invention to collect expression profile information together with demographic and medical history information to produce a database relating to expression patterns and variation to phenotype state and prognosis. It is a further objective of the present invention to have an Internet analysis site and database of the selected animal genomes, metabolism maps, clinical data and other biological indicators and conditions with conclusions and interpretations associated with the differential expression of certain genes and other biological parameters. It is yet another objective of the present invention to allow responsible individuals to collect and digitize (or render in some other transmittable form) sample I expressions profiles (or other biological information) at home, or at some convenient site such as a veterinary's office, or via some hand held device to provide
that digitized individual expression profile (or other biological information) over a network to a central analysis site, and to have that analysis site provide an interpretation of an animal's expression profile with conclusions regarding the animal's condition. It is yet another objective of the present invention to provide an analysis tool comprising a browser and analyzer that will allow the data to be transmitted to the analysis site, analyzed according to the animal's standard expression data stored in a specific biological database, and to have a response generated to be sent to the pet owner in a electronic, magnetic, written or audio form so that such persons can get results of the analysis right away on the comparison and differences from the standard expression profile. These and other objectives for the present invention will become apparent from a detailed review of the specification that follows. The present invention comprises a plurality of analysis devices and other detection means that can be produced and distributed to responsible individuals and professionals in the veterinary sciences in great quantities. It is the intention of the present invention to produce such analysis devices in sufficient quantities so that they can be made available to all who desire them in a cost effective fashion. Over time it is expected that the cost of such analysis devices will decease dramatically and therefore allow analysis devices to be available to anyone desiring to characterize the expression of their genome or other biologically related information.
These analysis devices are used by a responsible individual for determining an animal's control or "standard" expression profile of an animal's genes or other biological indicators that are to be monitored. A sample of blood, saliva, or urine is obtained and placed in / on the analysis device. The analysis chip, for example, contains probes for animal genes linked to the surface of the chip. Such chips are capable of detecting the presence of other nucleic acids (specifically messenger RNA), which are present in the solution via homology hybridization. Analysis Chips may contain small fragments of the genes (oligonucleotides) or expressed sequence
tags (ESTs) or RNA molecules or their fragments as well as proteins or their fragments. Other detector devices will have similar mechanisms for detecting the biological indicator of interest. Other types of devices include, and without limitation, a "lab-on-a-chip" with microchannel separation of biological materials (DNA, RNA, protein, hormone, small molecule, peptide, metabolite) with subsequent electrochemical or electric, such as those of Clinical Micro Sensors or optical, such as those of PharmaSeq detection. Such technology also includes 3D silicon particles of cubic or spheric shape, which could carry detection molecules (DNA, RNA, antibodies). The amplification via polymerase chain reaction (PCR) or other methods may be required for enhancing the strength of the signal in biological sample. These above methods are not meant as a limitation. For example, immunoassays, small molecule sensors for metabolites, peptides, hormones and other measures are also within the scope of the present invention. The emphasis in all cases however, is to measure these response variables and record the status at a variety of times in the lifespan of the animal so that predictions of future health can be made. The expression or recording of these biological indicators can then be digitized or put in some other transmittable form at home or at a convenient location on the analysis device reader or other device to make the genetic expression or recording of biological indicators of the individual in the form that is transmittable via the network. Based on the reading, a digitized record of the expression profile of the genome of the animal, which includes transcriptome (all molecules of RNA expressed in the cell as well as in the body), proteome (i.e. the proteome is the summary of all proteins) or other biological indicator is then created. As part of the present invention, the hand held device or computer attached device or real time monitoring station will detect genetic variations of the animals, including, but not limited to, Single Nucleotide Polymorphisms (SNPs) as well as genetic variations in genes of another nature. Those will be compared for a particular an animal over
time - giving a chance to build a time-correlation of the progression of the disease. Clinical data will be used to compare populational data of norm versus disease. SNPs could be detected in devices developed by Hyseq or Sequenom, or other manufacturers. Genetic variation noted above can be accomplished on a general basis where many genes are detected and analyzed or, when suggested via background or family history, on a specific SNP analysis based upon expression work done previously. This could be done at the home or at an analysis station or at a regional laboratory. As part of the present invention, an analysis and database site exists on a network, preferably but without limitation on the Internet, that has extensive information on the animal genome and the meaning of various genetic expressions and mutations as well as metabolism maps. A veterinary professional wishing to have an animal's expression profile reviewed, read, and interpreted will send a digitized record created at the analysis device reader over the Internet, or via some other wired or wireless network to the analysis site. The software routines for analysis and interpretation at the analysis site will then read the digitized or transmittable record and interpret that record providing feedback to the responsible individual over the Internet, over an intranet, a wireless network or via any other means (such as voice) for conveniently reporting such information to the responsible individual. A standard PC could also be used for storage and interpretation as well as warning the veterinary professional. Such an invention can also be used to simply provide an expression profile for an animal when that animal is healthy. This "standard" or "baseline" gene expression profile is then stored at the analysis site for later use. This will be important since expression of genes varies with disease and also varies over one's lifetime. Further when an animal is not healthy, that animal can create a new gene expression profile, read and digitize the Analysis device results, provide the results to the analysis site over the Internet, or to a standard PC, compare the digitized results to that animal's baseline or standard expression profile, and make some
determination on what has changed and what the impact of that change actually is. Once information is developed based on the gene expression profiles, analysis results can be reported to the field where corrective action can take place. Analysis of results prior to reporting is accomplished by organizations having databases specific to the species involved. It is realized that certain regulatory issues arise with such advice. Where this is the case, information can also be provided to a veterinarian professional for analysis and discussion with the responsible individual. The control gene expression profile or other biological characteristics will also have other uses. From time to time, over a period of years, an animal can provide a new series of digitized or otherwise recorded biological indicators to the analysis site central database and determine how the animal's expression profile is changing. This may suggest certain interventions on the part of the pet owner. The present invention provides for a flexible series of methods and associated apparatus allowing responsible individuals to create a record of the animal's gene expression (RNA and protein) to broaden profiles and other genomic and biological information in a convenient fashion. For example, one embodiment of the present invention provides for an analysis device reader to be attached or connected to the responsible individual's PC for subsequent reading and providing information over a network, which is preferably, but without limitation, the Internet. In another embodiment, analysis device readers may be located in veterinarians' offices to provide such information for subsequent analysis when a personal computer and analysis chip reader is not available. Yet another alternate embodiment allows for a single purpose analysis device reader, which can provide genetic information over a network. Such a device may be a single purpose device optimized to look for a specific gene, metabolite or other indicator of a condition. Yet another alternate embodiment allows for the wireless presentation of analysis device information over a radio network, for example over a cellular network. In this alternate embodiment a form of wireless or cellular type
device, hereinafter referred to as a genophone, allows genetic or other biological information to be provided over wireless and/or cellular type networks to an analysis center. Yet another alternate embodiment of the present information allows for a kiosk type operation whereby an analysis device dispenser is located in a public area, such as a mall, or hospital or indeed any other public area. In use, a responsible individual would simply use a credit card or, preferably a smart card having specific encrypted identification information, that is linked to a credit card processing company such as American Express ®, VISA®, MasterCard®, or other for billing services. The responsible individual simply inserts the credit smart card and, after credit verification, would receive an analysis device upon which a biological sample, form an animal could be deposited. The analysis device would then be read by the kiosk analysis device reader and information from the reading sent to the analysis site. Thereafter, the responsible individual can enter information either at the kiosk location or, using coded information that is present on the smart card, the responsible individual can cause the results of the analysis to be sent to the responsible individual via the US Mail, via electronic mail, or via any other selected delivery service which the user prefers including voice transmission to a selected telephone number or voice mail. In any case, such information is sent to the person involved together with information on how to locate source to assist in proper interpretation or the data. In certain instances, identification of counseling and scientific resources would also be identified depending upon the outcome or projected outcome to help the responsible individual understand the results received. The present invention also comprises a genome and health information- specific encrypted browser for a responsible individual to use. This browser, when used with the personal computer or in use with video phones or the like, allows genomic and other biological information from the responsible individual to be appropriately delivered directly to an analysis site as well allows rapid and encrypted access to specific medical and gene analysis sites. In this fashion responsible
individuals will not need to expend significant effort in browsing the World Wide Web for information to support conclusions or preliminary analyses made concerning the animal's gene expression profile. Using the encrypting browser, the responsible individual can access a database of genomic and other biological information of the present invention that comprises the control expression profiles of the animal and management of the animal's medical information, all of which will be encrypted. However, in addition there will be a database of metabolic pathways, which will be used to characterize the protein or other expression molecules and characterize and tell what role the protein that is detected has in the overall health of the animal. It is part of the present invention to develop a secure bank-type of mechanism, which will allow for the secured transaction of the genomic and proteomic information by responsible individuals. Such a facility could be established with a partner (i.e. American Express). An animal genome sequence comparison database is also a part of the present invention and allows animal control expression profiles as well as subsequent expression profiles to be compared to various standard expression profiles for analysis purposes. Further, the database will contain subsequent databases and/or links to clinical data, clinical trials in practice, "live" consulting with experts as well as chat rooms to discuss with other responsible individuals genomically, biologically, and medically important information. In addition to these above databases, the database of the present invention comprises Single Nucleotide Polymorphisms (SNP), DNA sequencing, protein- protein interactions and protein-drug interactions so that responsible individuals who generate an animal's expression profile (protein and other molecules) can review what potential drug interactions might be specific for that animal. Any information that a responsible individual wishes to store that is particular to the responsible individual's concern (about animals, such as past illnesses, accidents, or allergies) can be stored in the individual storage area of the database in
an encrypted form so that only the responsible individual who has placed that data in the database can have access to the data. The genophone described above will have a series of capabilities. For example it will be able to read DNA or RNA using an appropriate DNA or RNA chip and transmit that information over the wireless network to the analysis center. These chips mentioned above are not meant as a limitation. Other analysis devices as noted earlier will provide for other clinical targets as well such as peptides, hormones and metabolites. Further, the genophone will have a separate protein analysis cartridge, including those which could have antibodies, enzymes or other protein detection systems and separate sugars (or other biological molecules specific for animals) analysis cartridge each of which will be capable of receiving the associated device for deposit of a sample and analysis of the proteins, sugars and other metabolites as appropriate. It is further anticipated that these cartridges could integrated in one single cartridge or unit. This "cartridge" can be a variety of forms and the form is not meant as a limitation. In other forms it employs the various detection technologies discussed (above). For example, the cartridge may be an attachment to the genophone, or it may be its separate instrument or device with its own communications capability for providing information over a network. Cartridge may have different sets of detection mechanisms specific for a particular gene of the gene product or group of genes and their products, which could lead to different types of diseases, (i.e., a cartridge for monitoring gene expression which could lead to heart disease, diabetes or cancer). Cartridges with different types of disease "preventive" expression and other monitoring could combine different types of diseases on one cartridge. In addition, specific disease state monitoring can be accomplished by the equipment of the present invention. Thus monitoring diabetes, heart disease and other conditions can be monitored. Health care state during the course of drug delivery can also be monitored so that the treating veterinary professionals can assess the efficacy of the treatment and the extent to which treatment should
continue. Where the therapeutic range of a drug with the patient's system is narrow, such monitoring of the present invention will greatly assist the veterinary professional in monitoring and administering the drug in question as well as to monitor for adverse drug reactions. Expression analysis of the type disclosed with the present invention is well within the current state of the art. For example, a GeneChip™ is an analysis probe array manufactured by Affymetrix® which can detect MRNA transcripts at a few copies per cell. It can also identify concentration levels and simultaneously monitor thousands of genes. This GeneChip™ system is typically scanned by an HP GeneArray scanner to view an expression analysis. Yet another potential technology for analysis is the Assembled Array™ manufactured by lllumina, Inc. This array provides thousands of sensors to analyze DNA, RNA, and protein. Yet another example of chip analysis technology is the ProteinChip™ which is available from Ciphergen. Other analysis devices such as the GeneChip™ instrument system, also available from Affymetrix which provides a platform for analyzing GeneChip probe arrays. In short, certain of the building blocks are readily available for the present invention. Brief Description Of The Figures Figure 1 illustrates the overall architecture of the present invention Figure 1A illustrates the stand-alone analysis device reader Figure 2 illustrates the genophone embodiment of the present invention Figure 3 illustrates the kiosk embodiment of the present Invention Detailed Description Of The Invention The present invention is a system and method for creation of expression profiles of animals, establishing a control expression profile for an animal, and comparing subsequent expression profiles to the control expression profile for analysis purposes. For purposes of this detailed description of the invention, the procedures when dealing with animal genomic information will be discussed. Any reporting that is done will be in terms of the animal in question.
Referring to Figure 1 , responsible individuals will initially provide a control biological sample, of the animal, on analysis devices 22, 24,and 26. The analysis devices will be input to analysis device readers 16, which, in one instance are connected to PCs 14, 20 at user locations. It is also considered to be within the scope of the present invention to have an analysis device reader / communicator 28 which is a stand-alone unit that reads analysis device 26 and provides that information over the Internet 18 or some other wired or wireless network adapted to convey such information or analyze the biological sample "on the spot" providing limited read out of the presence and / or quantity of the expression of gene or other biological factors, for example and without limitation, particular proteins and their amount (See Figure 1 A below). For example, an intranet may be constructed to send and receive such information among a variety of sites at a hospital, or other large organization. For example, a ranch has particular interest in the health and welfare of its livestock. Such an organization would not necessarily use the Internet but would use its own network for the transmission of such gene expression information. In other situations, a cellular network may be used to transmit the desired information when measurements are taken away from the ranch. Analysis device reader 16 reads analysis devices 22, 24 and presents a digitized, or otherwise transmittable record of the individual gene expression or other biological information to the PC 14, 20 at the users location. It should be noted that the "users" location may be a home based unit or a unit at a convenient location such as a veterinarian's office. These PCs will further comprise software for communicating with the analysis site. It is anticipated that connections to the Internet for reporting of these gene expression readings will be both wired as in the case of processor 20 connecting to Internet 18 and wireless as in the case of processor 14 connecting to a wireless fashion to Internet 18 or via other wireless special purpose devices optimized for the expression profile reporting of the present invention.
The expression profiles will then be provided to an analysis site 12 over a network such as, and without limitation, the Internet 18 and stored in database 10 identifying the record only in a numeric fashion in order to preserve the unanimity of the individual providing the information. The responsible individuals can report as many different gene or other biological expressions as desired since those expressions will vary by the time of day, over a period of years, and with the changing of an animal's conditions. Analysis site 12 receives the information from each responsible individual and based upon expression, protein, messenger RNA etc. detected, analyze and compare those results to information stored in the biological database. The analysis site 12 can create a reading of the expression profile of the animal together with an interpretation of any particular conditions that might exist. Information relating to the interpretation of the expression profile of the animal is then provided by analysis site 12 over the Internet 18 back to the responsible individual's processor 14, 20 for the responsible individual's information. Alternatively, information from the interpretation of the genomic expression can be provided to the user via mail. It is expected, that as analysis device prices decrease, such analysis devices will be readily available at a reasonable cost to all responsible individuals who desire to use this process. Furthermore, it is also expected that each animal's genes will be sequenced (all or in part) which will allow the creation of the "Individualized Analysis Devices." Those will be used not only to establish controls and to obtain the genome expression reading, but to track any changes in the animal's genes. The difference in the expression of the animal's genes as well as detection of the specific changes (including but not limited to mutations) may unravel the condition in the event that the animal is not healthy, as they age, and as other significant events occur which may affect the animal's overall health. All results from individual analysis device readings will be stored in the biological database for access by the responsible individual or a
veterinarian over time. It is also suggested by the present invention that the analysis device may be used for detecting any endemic viral or bacterial gene or other biological expressions occurring in the animal's body, which could result in disease or other malfunction of the body. In addition to tracking expression profiles, by virtue of understanding each animal's gene expression, medications or treatments can be recommended to a responsible individual that will be best suited to change or correct that animal's expression profile or deal with a manifested condition. For example there may be a gene expression, which predisposes an animal to react adversely to certain medications or treatments. Similarly there may be certain protein-drug interactions about which an individual should be wary as the owner of the animal. Thus as part of the interpretation of the gene and other biological expression of the animal, recommendations for medication can be made to the individual. Further, based upon individual gene expression, "targeted" drugs could be designed which work in an optimal fashion for the particular animal, as well as target "preventive" drugs. In addition to whether certain medications could be taken or not, the effectiveness of certain medications also depends upon the gene expression of the animal. In this case information can be provided to a responsible individual as to which medications or treatments that are best suited for that particular animal in a particular situation. From an economic standpoint, responsible individuals will be able to purchase analysis devices 22, 24, and 26 at a reasonable cost once these chips are readily made available to millions of individuals. Each time a reading is interpreted by the genomic processor the responsible individual can be charged for that particular interpretation. Referring to Figure 1A, the analysis device reader 16 in a stand-alone mode (as first noted above) is illustrated. In certain instances and where an individual does not want to have genomic or other biological factor information transmitted over a
network, a stand-alone analysis device reader 16 can be used. This analysis device reader uses the analysis device 24 to collect a biological sample. The analysis device 24 is placed in the analysis device receptacle 70, which is powered by a stand-alone power supply 62. This power supply can be single use or rechargeable battery supply, and may also be plugged into household current to recharge batteries or to simply power the stand-alone device. The analysis device reader 16 comprises analysis logic 64 for interpreting the analysis device readings. Thereafter, the reading may be stored in a memory 66 in the case where the user wants to have an historical record of readings over a period of time. The analysis device reader 16 also comprises a screen or display 68 for providing a limited readout of the presence of or quantity of the biologic factor or substance being collected by the analysis device 24. In this fashion, for example, if a particular biological factor is not present, and this is not troubling for the user, the results do not have to be sent over a network and risk a disclosure of the fact that such a test is being conducted by the user. Alternatively, if the results of the readout are such that the user desires to send information, the analysis device reader also comprises a communication port 68 which may be connected to a network for transmitting information stored in memory over the network as described in Figure 1 (above). The display, analysis logic power supply and readout capabilities are generally disclosed in U.S. Patent No. 5,837,546, which is incorporated herein in its entirety. However, the capability to analyze the genetic, proteomic and other biological factors described herein constitutes a novel capability within the current state-of-the-art. By virtue of the memory in the analysis device 16 certain limited expression comparisons can be made from one reading to another. When a difference above a certain threshold occurs between two readings the analysis logic 64 can inform the user of the detection of that difference via the readout / display 68. Thereafter, if the user chooses that information can be sent to an analysis processor (Figure 3, 12) via
the comm. port 68. Referring to Figure 2 the genophone of the present invention is illustrated. The genophone 30 is a form of cellular communications device having its own transceiver 44 connected to the cellular network 45 which in turn subsequently is linked to analysis processor 12 via a wireless application protocol (WAP) gateway 47 and thence over the Internet 46 to the analysis site. The characteristics of the WAP gateway are described in U.S. Patent No. 5,327,529, whose contents are incorporated herein by reference in their entirety. The linkage to the analysis processor can also be via the wireless network directly where the analysis center is capable of receiving an electronic signal from the genophone over its own wireless transceiver or alternatively the genophone can ultimately connect to an Internet service provider via a WAP gateway as noted above and electronic information concerning data collected can then be presented to the analysis via the Internet as described earlier. The genophone has a series of cartridges or readers illustrated as sugar reader 32, DNA reader 34, and protein reader 36 although these readers are not meant as limitations. For example it is fully anticipated that as the bio/genomic science becomes more refined, other combination readers having this combinations or others are also anticipated. Each cartridge will have an associated analysis device illustrated as a sugar chip 38, a DNA chip 40 and/or a protein chip 42. As noted earlier, these chips are not meant as a limitation. Analysis for peptides, small molecules, hormones, and metabolites are yet further examples, and are not meant as limiting, of the types of indicators that can be monitored using the present invention. Referring to Figure 3 a kiosk-oriented embodiment of the present invention is illustrated. Central to this embodiment for expression profiling is a form of kiosk 60 which would reside in a more or less public area such as a mall, a veterinarian's office, and/or a hospital. In this embodiment a responsible individual possessing a
credit card or, preferably, a smart card 62, which would be associated with a credit card issuer such as VISA®, MasterCard® and American Express® would have individualized identification information stored, in encrypted form, on the smart card 62. A responsible individual who wishes to establish a control expression profile or to simply create an expression profile at that point in time would use the smart card to begin the over all process of establishing an expression profile in much the same way that an individual now uses a credit card and automated teller machine to begin a financial transaction. The responsible individual would insert the smart card 62 in the kiosk 60. Once the appropriate credit was established with a credit facility 66, which is the normal type of electronic credit transaction that establishes that a responsible individual has a certain amount of credit and has entered the appropriate security information either via a key board or through some biometric measurement, the kiosk 60 is permitted to perform further functions. After the kiosk receives the appropriate authorizations from the credit facility for the financial aspect of the transaction, the kiosk provides analysis device 64 to the responsible individual. As noted above the analysis device may be a sugar analysis, DNA analysis, and/or a protein analysis device as appropriate although this is not meant as a limitation. Analysis for peptides, small molecules, hormones, and metabolites also occur. The user deposits a biological sample on the analysis device and reinserts the analysis device into the analysis device reader in the kiosk. Thereafter an analysis device reader in the kiosk reads the information on the analysis device in much the same way that individual cartridges read the chip in the genophone embodiment first noted above. Once the information on the analysis device is read, the digital information, or other transmittable information, which characterizes the biological sample is passed over a network to the analysis processor 12, which creates the desired expression profile. As noted earlier, the kiosk itself may be a cellular or wireless device that communicates with the analysis
site in a wireless fashion. Information can be entered by the user at the kiosk regarding the location to which the information is to be sent. Thus the user can specify that resulting information be sent to an associated e-mail address, be sent over the mail system to the user, to be reported via voice or delivered in other ways known to those skilled in the art. Similar to the genophone noted above, the kiosk can also communicate to the analysis center over a cellular or other wireless type network. Thus without limitation, the kiosk can report its results to the analysis via wired network, wireless networks, cellular networks, and other communications methods known in the trade including satellite communications as well. Encryption of the resulting data can be accomplished by an appropriate encryption key stored on the smart card of the responsible individual and conveyed to the kiosk for subsequent encryption to the analysis center. As part of the database operations of the present invention, individual expression profile information in a secure fashion. In addition, once specific conditions are assessed by virtue of expression profile comparison, the analysis processor of the present invention will review all files in its database and send the latest health news that relates to the diseases or conditions evidenced by the expression profiles stored in the database. In this fashion, and individual with, for example, diabetes, can receive the latest information that breaks relating to this condition or on the latest equipment available for maintaining a healthy state. Such information can be delivered via pager, wireless telephone, PDA, and or email. The organization that is responsible for the analysis processor will also receive notices of research projects requiring test subjects. When such notice is given, the database of the present invention be searched and, if authorized by the affected individual, those whose conditions are to be the subject of such medical research will be provided notice of the need for test subjects. Again, in this fashion the database will be able to alert those with specific conditions or expression profiles
of the opportunity to participate in such studies. The ramifications of this invention are significant. For example, while DNA, protein, mRNA, sugars and the like have been mentioned as items to be monitored, so can small molecules, peptides, hormones and metabolites. These items will also serve to establish a baseline when the individual is healthy and can later be monitored as potential precursors to a disease state(s). Further, as the monitoring of the present invention takes place, the information gleaned can be stored in an anonymous way in a database so that individual variation can be interpreted not just with respect to other measurements from the same individual, but can also be interpreted in the context of larger demographic results. Additionally, monitoring of those individuals undergoing therapy of various types is very important where there is a possibility of an adverse drug reaction or where a narrow therapeutic range is desirable for the drug in question. Real time monitoring of various indicators as noted in the present invention can help to avoid such adverse drug reactions. A genome and biological factor assessment apparatus and method in alternate embodiments has now been shown. It will be apparent to those skilled in the art that other applications and businesses can benefit from this model of DNA chip reading and genome information storage without departing from the scope of the invention as disclosed.