WO2008096311A2

WO2008096311A2 - A system and a method for preventing abuse of a biological sample

Info

Publication number: WO2008096311A2
Application number: PCT/IB2008/050399
Authority: WO
Inventors: Alphons A. M. L. Bruekers
Original assignee: Koninklijke Philips Electronics N.V.
Priority date: 2007-02-08
Filing date: 2008-02-04
Publication date: 2008-08-14
Also published as: WO2008096311A3

Abstract

The invention relates to a system for processing information obtained from a biologicalsample of a mammal. The system comprises an analyzing unit (AU) for analyzing information from the biologicalsample of the mammal, the analyzing unit can extract first and second information from the biologicalsample:a) The first information (ID-INF) being related to a personal identification of the mammal, the first information being extracted by genetic identification processing, and b) The second information (DIAG-INF) being related to the health and/or condition of the mammal. Further, an authorization database (ADB) receives the first information (ID-INF) from the analyzing unit (AU), the authorization database comprising corresponding sets of personal identification (IDi) ofmammals and an authorization level(ALi)for each mammal. Additionally, a processing unit (PU) receives the second information (DIAG-INF) from the analyzing unit and process the second information into third information (RES), e.g. a diagnostic result. The processing/accessing of the second information (DIAG-INF) into third information (RES) isdependent on the authorization level (ALi) of the mammal from which the biological sampleis obtained. The invention is advantageous in that the processing/accessing of the second information (DIAG-INF) is thereby restricted by the authorization level (ALi) of the corresponding mammal.

Description

A system and a method for preventing abuse of a biological sample

FIELD OF THE INVENTION

The present invention relates to a system and a method for controlling the use of a biological sample. The invention also relates to an analyzing unit, a method, a corresponding computer program product of the method, and an authorization database, for application in connection with the present invention.

BACKGROUND OF THE INVENTION

With recent advances in medical diagnostics, including the application of sophisticated biosensors for use in the home or by a general practitioner, the spreading of such technologies outside of specialized laboratories involves some risks with respect to the protection of privacy of an individual if the flow of information is not limited either by law and/or by built-in security measures in the medical technology. In particular, the advances within genetic diagnostics, where e.g. a single hair with some root cells can be used for a complete or partial genetic mapping of an individual, can result in a severe breach of privacy if not limited one way or another.

DNA (Deoxyribo-Nucleic Acid) is found in basically every cell (not in red blood cells of mammals) of a living organism and determines in great extent the physical characteristics, e.g. gender and color of the eyes and hair. For humans, DNA consists of long strands of in total about 3 billion nucleotides for which only 4 different nucleotides, identified with A, C, G and T, are used. Extensive knowledge of DNA, i.e. its functionality and the DNA sequence of a particular person allows for many applications in the field of healthcare. DNA can e.g. be used for early diagnosis and personalized medicine.

Currently many research initiatives and programs are directed towards a better understanding of DNA and towards more accurate, cheaper and/or faster methods for determining the genetic sequence of an individual. But already today it is possible to analyze specific parts of DNA. Depending on the application, different techniques are applied for analysis. Firstly, DNA has to be extracted from a possibly contaminated biological sample, and, secondly, the DNA may be amplified to have sufficient material for subsequent testing. Various methods exist for this testing, e.g. hybridization based assays such as southern blots, northern blots or microarrays, PCR based analysis and magnetic biosensors.

Currently, the secrecy of an individual performing home testing with a diagnostic purpose may be controlled by a PIN (personal identification number) code access control system. For example US patent application 2001/0012611 discloses such a system with an anonymous test kit for example for HIV testing. By coupling a personal code with a specific test kit, anonymity is conserved. The anonymous testing system comprises means for taking a sample of body fluid to be tested; the sample is preferably acquired in private and sent to be analyzed to obtain results. The system comprises a test kit for creating a sample of body fluid, a personal code for anonymously identifying the sample and the person, and an electronic file telephonically created and accessed by the person taking the test and identified by the personal code. However, this system does not prevent a third party, who has obtained, in unauthorized manner, a biological sample (e.g. a hair or some blood), from performing a diagnostic test on the biological sample. Rather, the system may protect the privacy of the person who requests the diagnostic result. Thus, with the recent advances in medical diagnostics, there is a risk that uncontrolled use of biological samples may take place. For instance, an employer or an insurance company may be tempted to perform unauthorized diagnostic testing relevant for the condition and/or medical well being of an individual.

Hence, an improved system for preventing uncontrolled use of a biological sample would be advantageous, and in particular a more efficient and/or reliable system would be advantageous.

SUMMARY OF THE INVENTION

Accordingly, the invention preferably seeks to mitigate, alleviate or eliminate one or more of the above mentioned disadvantages singly or in any combination. In particular, it may be seen as an object of the present invention to provide a system that solves the above mentioned problems of the prior art with protecting the privacy in connection with a biological sample and/or preventing the uncontrolled use of such an biological sample. This object and several other objects are obtained in a first aspect of the invention by providing a system for processing information obtained from a biological sample of a mammal, the system comprising: an analyzing unit (AU) for analyzing information obtainable from the biological sample of the mammal, the analyzing unit being adapted for extracting at least a first and a second information from the biological sample: a) The first information (ID-INF) being related to a personal identification of the mammal, the first information being extracted by genetic identification processing, and b) The second information (DIAG-INF) being related to the health and/or condition of the mammal, an authorization database (ADB) arranged to receive the first information (ID- INF) from the analyzing unit (AU), the authorization database comprising corresponding sets of personal identification (IDi) of mammals and an authorization level (ALi) for each mammal, and a processing unit (PU) arranged for receiving the second information (DIAG- INF) from the analyzing unit and processing the second information into third information (RES), wherein the processing of the second information (DIAG-INF) into third information (RES) is dependent on the authorization level (ALi) of the mammal from which the biological sample is obtained, and/or wherein accessing the second information (DIAG-INF) and/or accessing the third information (RES) is dependent on the authorization level (ALi) of the mammal from which the biological sample is obtained.

The invention is particularly, but not exclusively, advantageous for obtaining a system, wherein the processing of the second information (DIAG-INF) is restricted by the authorization level (ALi) of the corresponding mammal. In that way, the privacy of the mammal, e.g. an individual human being, can be respected. The invention is advantageous in that the first information (ID-INF), which is being extracted by genetic identification processing, can uniquely identify a mammal.

The invention may, in particular, find application in connection with human beings, but the invention is not limited to such application, as it may be foreseen that owners of pets, high-value racing horses or camels, high-value breeding animals (cows, sheep, etc.) may also desire a restriction on the flow of information related to their animals. In the following, the term "individual" will however be used in connection with a human being (homo sapiens).

It is further to be understood in the context of the present invention that the processing and accessing of second and/or third information, also includes transfer of such information, e.g. between two interconnected computers operating as server and host.

It is also to be understood in the context of the present invention that the accessing of the second and/or third information may be controlled by appropriate cryptographic means, such as public or symmetric key algorithms.

The invention may rely, at least in part, on a commonly recognized, trusted, third party, e.g. a governmental organization, an intergovernmental organization, or a non- governmental organization (NGO), operating the authorization database (ADB) according to the present invention in order to secure the processing of information originating from biological samples. As an example, Great Britain currently has one of the most extensive DNA database in the world, with well over 2 million records as of 2005 : The National DNA Database (NDNAD). Such a database may very well be applied in the context of the present invention, where a central authorization database (ADB) is linking individual identifications (IDi) with corresponding authorization levels (ALi), thereby restricting the information flow derivable from a biological sample of an individual. Thus, without legislation and/or technical measures that prevent unauthorized information processing, it may be difficult to secure the privacy of individuals with respect to the second information (DIAG-INF) derivable from the biological sample.

It may be argued that the full potential of the present invention may only be realized if all relevant processing units (capable of receiving and processing second information (DIAG-INF)) are actually connected to an authorization database so that the flow of information is restricted according to the corresponding authorization levels. However, this can be enforced by legislation. This is presently the case in many countries with processing of various diagnostic information, in particular genetic information. Beneficially, a receiving unit (RU) may further be provided for receiving and preparing the biological sample of the mammal, the analyzing unit (AU) being arranged for co-operation with the receiving unit for manipulating the sample, e.g. blood, hair, saliva, semen, etc.

Advantageously, the system may be further arranged to perform a request process (REQ), in which a requester with a key (K) requests access to and/or processing of the second information (DIAG-INF), and/or access to third information (RES), the request process being performed in relation with the first information (ID-INF) of said mammal. This provides an additional level of security, where e.g. the key K may be a PIN code, which is matched against first information (ID-INF), e.g. a genetic identity code. This may limit abuse while giving e.g. a parent with a child access to the third information (RES) for his own child. Moreover, the key (K) may have a corresponding authorization level (ALi) for providing key-role based access to the system with keys having several levels for limited access. For instance an employer or an insurance company could have very limited access, but nevertheless some access, to an individual's information derivable from a biological sample. The key may have limited duration in time. The key may be genetic ID as the first information ID-INF, fingerprint, retinal scan, etc.

Preferably, the second information (DIAG-INF) relates to the health and/or condition of the mammal (10) and comprises information extracted by analysis of DNA or RNA or comprises information extracted by analysis of the physical state or level of one or more proteins.

Typical methods for analysis of DNA are methods such as DNA sequencing, snp analysis, PCR, southern blotting, northern blotting, dot blotting, microarrays, mass spectrometry, restriction analysis, etc. DNA sequencing may be employed to extract detailed information of any desirable genetic bio markers. However, very often it will be more desirable to use methods which allow a higher throughput, or are simpler to use. Such assays could e.g. be PCR, southern blotting, northern blotting, dot blotting, microarrays, mass spectrometry, restriction analysis etc. Also proximity detection systems like FRET (Fluorescence resonance energy transfer) are suitable. Methods for analysis of proteins are e.g. immunoblotting, other antibody based detection systems, proximity bases detection systems like FRET, mass spectrometry, gel electrophoreses (SDS-page, both ID and 2D) protein arrays/chips etc.

For each given purpose, i.e. analyzing DNA, RNA or proteins, there will be a range of methods that can be employed and such methods are known to the skilled person. The present invention is not concerned with the development of such methods, but is rather concerned with the control of information that can be extracted using such methods.

Preferably, the first information (ID-INF) describes genetic markers selected from the group consisting of: VNTR (variable number tandem repeats), STR (short tandem repeats) and SNP (single nucleotide polymorphism). The number of markers used may be adjusted so as to improve the specificity of identification. With more markers, the discriminatory power improves.

A preferred kind of marker is the short tandem repeats. These short sequences (e.g. length 4 or 5) of nucleotides repeat a number of times and the number of repetitions varies largely over the population. Although the number of repetitions differs, the subsequences in front and after the repetition are constant. This phenomenon is called a Short Tandem Repeat (STR) and is ideal for identification.

By selecting STR-loci on different chromosomes the statistics per STR are independent. In Europe the SGM-plus method is used that finds 10 STR loci and a gender indication area. Figure 5 shows an example DNA-profile as obtained with the SGM-plus method (from www.forensic.gov.uk). Per locus two peaks are found (heterozygous) where one peak is inherited from the father and the other from the mother. In case only one peak is found (not in figure 5) the number of repeats inherited from the father and the mother are equal (homozygous).

Within Europe the same set of loci is analyzed such that data can be exchanged between forensic institutes in different countries. However, in the US and Canada a different set of loci is defined. Both sets have a small number of loci in common that enables comparison at a lower level of reliability. As mentioned previously a large variation of repeats over the population is found. It is also found that statistics may differ per group of population. For each STR locus this data is available and based on that it can be derived that the worst-case probability for a random match is less than 10^~9.

If the DNA-profile found at a crime scene exactly matches the DNA-profile of a suspect, there is a close to 1 probability that the material relates to the suspect (there is a chance for a random mismatch). But even in case of a limited number of mismatches, a relation cannot be excluded. From the e.g. 10 loci that are analyzed for their STRs in total 20 values result

(2 for each locus k i.e. [a,b]k). For each locus the pairs of values should be the same for the sample and the suspect: Vk:[a,b]_sampie,k⁼[a,b]_Suspect,k where [a,b]k=[b,a]k. In case of a homozygous locus both values of a pair are the same i.e. [a,a]. Ideally all 20 values will match exactly but due to all kind of reasons like mutations a small number of mismatches have to be tolerated.

STR markers with detailed information can be found at the STR Base: www.cstl.nist.gov/biotech/strbase/index.htm

In a preferred embodiment, the STR-markers used with the system of the invention comprise at least one STR marker selected from the group consisting of: CSFlPO, TPOX, D5S818, D7S820, D13S317, D3S1358, VWA, D16S539, D2S1338, A (gender marker Amelogenin), D8S1179, D21S11, D18S51, D19S433, THOl and FGA.

In another embodiment, the number of STR-markers used with the system is selected from the group consisting of least 2 markers, at least 3 markers, at least 4 markers, at least 5 markers, at least 6 markers, at least 7 markers, at least 8 markers, at least 9 markers, at least 10 markers, at least 11 markers, at least 12 markers, at least 13 markers, at least 14 markers, at least 15 markers, at least 16 markers, at least 17 markers selected from the group consisting of: CSFlPO, TPOX, VWA, D5S818, D7S820, D13S317, D3S1358, D16S539,

D2S1338, A (gender marker Amelogenin), D8S1179, D21S11, D18S51, D19S433, THOl and FGA. In another embodiment, wherein the STR markers comprise at least the group consisting of CSFlPO, FGA, THOl, TPOX, VWA, D3S1358, D5S818, D7S820, D8S1179, D13S317, D16S539, D18S51 and D21S11 or at least the group consisting of D3S1358, VWA, D16S539, D2S1338, A (gender marker Amelogenin), D8S1179, D21S11, D18S51, D19S433, THOl and FGA.

The first information (ID-INF) and the second information (DIAG-INF) may comprise overlapping information. Thus, genetic markers may be chosen that serve both identification purposes and diagnostic purposes. In such a situation, the total amount of information that needs to be extracted from the biological sample will be reduced.

Extracting information from the biological sample by genetic identification processing may comprise restriction digestion, electrophoresis and hybridization with a labeled probe. These are the typical steps of a so-called RFLP (restriction fragment-length polymorphism) analysis.

Extracting information from the biological sample by genetic identification processing may also comprise carrying out a polymerase chain reaction (PCR). Thus, the length of STRs may be analyzed by PCR followed by electrophoresis. Employing PCR has the advantage of improving sensitivity, i.e. only tiny amounts of biological sample are needed.

Extracting information from the biological sample by genetic identification processing may also comprise the use of a microarray. A microarray allows parallel processing of a large number of markers and can be used identification of markers in the form of snp's, STRs etc. The same microarray may be used to extract both the first and second information.

When the information extracted from the biological sample is genetic information, the information can be extracted from mitochondrial DNA, from chromosomal DNA or from both mitochondrial DNA and chromosomal DNA. The genetic information can also be extracted from RNA, e.g. in form of particular sequences (markers) or in the form of levels of one or more RNAs that may reflect a particular condition. In one embodiment of the invention, the analyzing unit (AU) is arranged for performing a consistency control of the first information (ID-INF) being related to a personal identification of the mammal.

The consistency control is being performed to ensure that the biological sample is not manipulated, either intentionally or non-intentionally.

The consistency control can comprise comparing the concentration of different genetic markers in the biological sample using e.g. qPCR. If one or more markers are too high or too low, this indicates that the sample is manipulated.

The consistency control may also comprise verifying that at most 2 alleles exist for each genetic marker. If e.g. STR analysis is used, at most 2 alleles of each STR marker should be present.

Still another consistency control comprises verifying the presence of all 23 chromosomes in the genetic sample in the case of a homo sapiens.

In a second aspect, the invention relates to analyzing unit (AU) for processing information obtainable from a biological sample of a mammal, the analyzing unit being adapted for extracting at least a first (ID-INF) and a second (DIAG-INF) information from the biological sample: a) the first information (ID-INF) being related to a personal identification of the mammal, the first information being extracted by genetic identification processing, and b) the second information (DIAG-INF) being related to the health and/or condition of the mammal, the analyzing unit (AU) being arranged to transmit the first information (ID- INF) to an associated authorization database (ADB), the authorization database comprising corresponding sets of personal identification (IDi) of mammals and an authorization level (ALi) for each mammal, and the analyzing unit (AU) further being arranged to transmit the second information (DIAG-INF) to associated processing unit (PU), said processing unit (PU) being arranged for processing the second information into third information (RES), wherein the processing of the second information (DIAG-INF) into third information (RES) is dependent on the authorization level (ALi) of the mammal from which the biological sample is obtained, and/or wherein accessing the second information (DIAG-INF) and/or accessing the third information (RES) is dependent on the authorization level (ALi) of the mammal from which the biological sample is obtained.

In a third aspect, the invention relates to an authorization database (ADB) for processing information obtained from a biological sample of a mammal, the authorization database being adapted to cooperate with an associated analyzing unit (AU) for analyzing information obtainable from the biological sample of the mammal, the analyzing unit being adapted for extracting at least a first (ID-INF) and a second (DIAG-INF) information from the biological sample: a) the first information (ID-INF) being related to a personal identification of the mammal, the first information being extracted by genetic identification processing, and b) the second information (DIAG-INF) being related to the health and/or condition of the mammal, the authorization database (ADB) being arranged to receive the first information (ID-INF) from the analyzing unit (AU), the authorization database comprising corresponding sets of personal identification (IDi) of mammals and an authorization level (ALi) for each mammal , and the authorization database (ADB) further being arranged to cooperate with an associated processing unit (PU), said processing unit being arranged for receiving the second information (DIAG-INF) from the analyzing unit (AU) and processing the second information into third information (RES), wherein the processing of the second information (DIAG-INF) into third information (RES) is dependent on the authorization level (ALi) of the mammal from which the biological sample is obtained, and/or wherein accessing the second information (DIAG-INF) and/or accessing the third information (RES) is dependent on the authorization level (ALi) of the mammal from which the biological sample is obtained.

In a fourth aspect, the invention relates to a method for processing information obtained from a biological sample of a mammal, the method comprising: analyzing information obtainable from the biological sample of the mammal in an analyzing unit (AU), the analyzing unit being adapted for extracting at least a first (ID- INF) and a second (DIAG-INF) information from the biological sample: a) the first information (ID-INF) being related to a personal identification of the mammal, the first information being extracted by genetic identification processing, and b) the second information (DIAG-INF) being related to the health and/or condition of the mammal, receiving the first information (ID-INF) from the analyzing unit (AU) in an authorization database (ADB), the authorization database comprising corresponding sets of personal identification (IDi) of mammals and an authorization level (ALi) for each mammal, and receiving the second information (DIAG-INF) from the analyzing unit (AU) in a processing unit (PU), said processing unit being arranged for processing the second information into third information (RES), wherein the processing of the second information (DIAG-INF) into third information (RES) is dependent on the authorization level (ALi) of the mammal from which the biological sample is obtained, and/or wherein accessing the second information (DIAG-INF) and/or accessing the third information (RES) is dependent on the authorization level (ALi) of the mammal from which the biological sample is obtained.

In a fifth aspect, the invention relates to a computer program product being adapted to enable a computer system comprising at least one computer having data storage means associated therewith to control a system for processing information according to the fourth aspect of the invention.

This aspect of the invention is particularly, but not exclusively, advantageous in that the present invention may be implemented by a computer program product enabling a computer system to perform the operations of the fourth aspect of the invention. Thus, it is contemplated that some known system for processing information may be changed to operate according to the present invention by installing a computer program product on a computer system controlling the said system for processing information. Such a computer program product may be provided on any kind of computer readable medium, e.g. magnetically or optically based medium, or through a computer based network, e.g. the Internet. The first, second, third, fourth, and fifth aspect of the present invention may each be combined with any of the other aspects. These and other aspects of the invention will be apparent from and elucidated with reference to the embodiments described hereinafter.

BRIEF DESCRIPTION OF THE FIGURES

The present invention will now be explained, by way of example only, with reference to the accompanying figures, where

Figure 1 is a schematic drawing of a system for processing information obtained from a biological sample of a mammal according to the present invention, Figures 2-4 are schematic drawings of three embodiments of a system according to the present invention,

Figure 5 is diagram showing an example of a STR-DNA profile, and Figure 6 is a flow chart of a method according to the invention.

DETAILED DESCRIPTION

Figure 1 is a schematic drawing of a system for processing information obtained from a biological sample 12 of a mammal 10, e.g. a human being, according to the present invention. The system for processing information obtained from a biological sample 12 of a mammal 10 comprises an analyzing unit AU for analyzing information obtainable from the biological sample 12 of the mammal, the analyzing unit being adapted for extracting at least a first ID-INF and a second DIAG-INF information from the biological sample.

A receiving unit RU can further be provided for receiving and preparing the biological sample 12 of the mammal 10, the analyzing unit AU being arranged for co- operation with the receiving unit as indicated by the arrow between the RU and AU. The obtained biological sample 12 can be blood, hair, saliva, etc. from the mammal 10 . The RU can perform cleaning and further preparation of the sample 12.

The first information ID-INF is related to a personal identification of the mammal 10, the first information being extracted by genetic identification processing. The first information ID-INF could e.g. be obtained from genetic markers selected from the group consisting of: VNTR (variable number tandem repeats), STR (short tandem repeats) and SNP (single nucleotide polymorphism). The second information DIAG-INF is related to the health and/or condition of the mammal 10, especially the future health of the mammal 10. In particular, the second information DIAG-INF could comprise information extracted by analysis of DNA or RNA involving methods such as DNA sequencing, snp analysis, PCR, southern blotting, northern blotting, dot blotting, microarrays, mass spectrometry, restriction analysis etc. Also the second information DIAG-INF could comprise information being extracted by analysis of the physical state or level of one or more proteins involving methods such as immunob lotting, antibody based detection, mass spectrometry, gel electrophoreses (SDS-page, ID, 2D), protein arrays/chips, or both of the aforementioned.

An authorization database ADB is accordingly arranged to receive the first information ID-INF from the analyzing unit AU, the authorization database comprising corresponding sets of personal identification IDi of mammals and an authorization level ALi for each mammal 10.

Likewise, a processing unit PU is arranged for receiving the second information DIAG-INF from the analyzing unit AU and processing the second information into third information RES. Thus, the third information could be a result of a diagnostic test, i.e. a positive or a negative result, but the third information could also be a more complex result, in particular the third information could also be an intermediate result, which needs further analysis and/or interpretation by a medically educated person.

According to the principle of the invention, the processing of the second information DIAG-INF into third information RES can then be dependent on the authorization level ALi of the mammal 10 from which the biological sample is obtained.

Alternatively or additionally, accessing the second information DIAG-INF and/or accessing the third information RES can be dependent on the authorization level ALi of the mammal 10 from which the biological sample is obtained.

In a straight forward embodiment of the invention, the authorization level ALi for mammal 10, i.e. an individual, can be set to either complete access (fully opened) or complete denial of access (fully closed). In that respect, the privacy of an individual can be respected if the said individual 10 has its authorization level ALi set at complete denial of access (fully closed) as no processing and/or accessing of second and third information can be performed. This can be done by default in the authorization database ADB, which means that each individual does not have to set the authorization database ADB to complete denial of access. Moreover, the authorization database ADB may as a default set the authorization level of an individual not present in the authorization database ADB to complete denial of access (fully closed). In that way, part of the authorization database ADB can also function as a "positive list" of individuals giving full access to information related to their condition and/or health, which may be quite attractive for research purposes.

In more sophisticated embodiments of the invention, the authorization level ALi of an individual can have more than two levels (fully closed/fully open). Thus, various degrees of access can be associated with an individual. This is particularly relevant in connection with embodiments where a third party or the individual himself 10 request access to information, see Figures 2-4 below.

Figures 2-4 are schematic drawings of three embodiments of a system according to the present invention, where the system is additionally arranged to perform a request process REQ, wherein a requester 20 with a key K requests access to and/or processing of the second information DIAG-INF, and/or access to third information RES, the request process being performed in relation with the first information ID-INF of said mammal 10.

Thus, an additional level of security is obtained. This can be implemented with e.g. the key K being a PIN code, which is matched against an appropriate genetic identity code corresponding to, or being equal to, ID-INF. The key could also be a biometric key like a fingerprint or retinal scan (iris-scan), a personal card or a token. The key could also be genetic identity information like the first information ID-INF, but preferably not as this embodiment does accordingly not keep the privacy of individuals.

In Figure 2, the requester 20 with a key K requests access processing of the second information DIAG-IN into third information RES by a request process REQ being performed in the authorization database ADB itself. Only in the case of matching key K with ID-INF, the request REQ is positive and may be continued. The continuation may be limited to a certain authorization level ALi corresponding to the specific key K, which is then sent to the processing unit PU.

In Figure 3, the requester 20 with a key K requests processing of the second information DIAG-INF into third information RES by a request process REQ being performed in the processing unit PU. Only in the case of matching key K with ID-INF, the request REQ is positive and may be continued. If negative, the processing of the second information DIAG-INF into third information RES, e.g. a diagnostic result, is not performed.

As an example, the requester 20 can be a parent seeking diagnostic information about his child, the child ID-INF being associated to a certain key K, which is entrusted to the parent. In Figure 4, the requester 20 with a key K requests access to third information

RES by a request process REQ being performed in connection with the processing unit PU.

Thus, second information can always be processed into third information, but the access to the information is limited by the authorization level ALi. Only in the case of matching key K with ID-INF, the request REQ is positive and access is granted to the third information RES.

Again, the access may be limited to a certain authorization level ALi corresponding to the specific key K.

Figure 5 is diagram showing an example of a STR-DNA profile. The profile has been generated using the SGM-plus system. Figure 6 is a flow-chart of a method according to the invention i.e. a method for processing information obtained from a biological sample 12 of a mammal 10, the method comprising:

51 analyzing information obtainable from the biological sample 12 of the mammal in an analyzing unit AU, the analyzing unit being adapted for extracting at least a first ID-INF and a second DIAG-INF information from the biological sample: a) the first information ID-INF being related to a personal identification of the mammal 10, the first information being extracted by genetic identification processing, and b) the second information DIAG-INF being related to the health and/or condition of the mammal 10,

52 receiving the first information ID-INF from the analyzing unit AU in an authorization database ADB, the authorization database comprising corresponding sets of personal identification IDi of mammals and an authorization level ALi for each mammal 10, and

53 receiving the second information DIAG-INF from the analyzing unit AU in a processing unit PU, said processing unit being arranged for processing the second information into third information RES, wherein the processing of the second information DIAG-INF into third information RES is dependent on the authorization level ALi of the mammal 10 from which the biological sample is obtained, and/or wherein accessing the second information DIAG-INF and/or accessing the third information RES is dependent on the authorization level ALi of the mammal 10 from which the biological sample is obtained.

The invention can be implemented in any suitable form including hardware, software, firmware or any combination of these. The invention or some features of the invention can be implemented as computer software running on one or more data processors and/or digital signal processors. The elements and components of an embodiment of the invention may be physically, functionally and logically implemented in any suitable way. Indeed, the functionality may be implemented in a single unit, in a plurality of units or as part of other functional units. As such, the invention may be implemented in a single unit, or may be physically and functionally distributed between different units and processors.

Although the present invention has been described in connection with the specified embodiments, it is not intended to be limited to the specific form set forth herein. Rather, the scope of the present invention is limited only by the accompanying claims. In the claims, the term "comprising" does not exclude the presence of other elements or steps. Additionally, although individual features may be included in different claims, these may possibly be advantageously combined, and the inclusion in different claims does not imply that a combination of features is not feasible and/or advantageous. In addition, singular references do not exclude a plurality. Thus, references to "a", "an", "first", "second" etc. do not preclude a plurality. Furthermore, reference signs in the claims shall not be construed as limiting the scope.

Claims

CLAIMS:

1. A system for processing information obtained from a biological sample (12) of a mammal (10), the system comprising: an analyzing unit (AU) for analyzing information obtainable from the biological sample (12) of the mammal, the analyzing unit being adapted for extracting at least a first (ID-INF) and a second (DIAG-INF) information from the biological sample: a) the first information (ID-INF) being related to a personal identification of the mammal (10), the first information being extracted by genetic identification processing, and b) the second information (DIAG-INF) being related to the health and/or condition of the mammal (10), an authorization database (ADB) arranged to receive the first information (ID- INF) from the analyzing unit (AU), the authorization database comprising corresponding sets of personal identification (IDi) of mammals and an authorization level (ALi) for each mammal (10), and - a processing unit (PU) arranged for receiving the second information (DIAG-

INF) from the analyzing unit (AU) and processing the second information into third information (RES), wherein the processing of the second information (DIAG-INF) into third information (RES) is dependent on the authorization level (ALi) of the mammal (10) from which the biological sample is obtained, and/or wherein accessing the second information (DIAG-INF) and/or accessing the third information (RES) is dependent on the authorization level (ALi) of the mammal (10) from which the biological sample is obtained.

2. The system according to claim 1, wherein a receiving unit (RU) is further provided for receiving and preparing the biological sample (12) of the mammal (10), the analyzing unit (AU) being arranged for co-operation with the receiving unit.

3. The system according to claim 1, wherein the system is further arranged to perform a request process (REQ), wherein a requester (20) with a key (K) requests access to and/or processing of the second information (DIAG-INF), and/or access to third information (RES), the request process being performed in relation with the first information (ID-INF) of said mammal (10).

4. The system according to claim 3, wherein the key (K) has a corresponding authorization level (ALi).

5. The system according to claim 1, wherein the second information (DIAG-INF) related to the health and/or condition of the mammal (10) comprises genetic information being extracted by analysis of DNA or RNA or comprises information being extracted by analysis of the physical state or level of one or more proteins or both of the aforementioned.

6. The system according to any of the preceding claims, wherein the first information (ID-INF) describes genetic markers selected from the group consisting of: VNTR (variable number tandem repeats), STR (short tandem repeats) and SNP (single nucleotide polymorphism).

7. The system according to claim 6, wherein the STR-markers comprise at least one STR marker selected from the group consisting of: CSFlPO, TPOX, D5S818, D7S820, D13S317, D3S1358, VWA, D16S539, D2S1338, A (gender marker Amelogenin), D8S1179, D21Sl l, D18S51, D19S433, TH01 and FGA.

8. The system according to claim 1, wherein the first information (ID-INF) and the second information (DIAG-INF) comprise overlapping information.

9. The system according to claim 1, wherein extracting information from the biological sample (12) by genetic identification processing comprises use of a microarray .

10. The system according to claim 1, wherein the analyzing unit (AU) is arranged for performing a consistency control of the first information (ID-INF) being related to a personal identification of the mammal (10).

11. The system according to claim 10, wherein the consistency control comprises comparing the concentration of different genetic markers in the biological sample.

12. An analyzing unit (AU) for processing information obtainable from a biological sample (12) of a mammal (10), the analyzing unit being adapted for extracting at least a first (ID-INF) and a second (DIAG-INF) information from the biological sample: a) the first information (ID-INF) being related to a personal identification of the mammal (10), the first information being extracted by genetic identification processing, and b) the second information (DIAG-INF) being related to the health and/or condition of the mammal (10), the analyzing unit (AU) being arranged to transmit the first information (ID- INF) to an associated authorization database (ADB), the authorization database comprising corresponding sets of personal identification (IDi) of mammals and an authorization level (ALi) for each mammal (10), and the analyzing unit (AU) further being arranged to transmit the second information (DIAG-INF) to associated processing unit (PU), said processing unit (PU) being arranged for processing the second information into third information (RES), wherein the processing of the second information (DIAG-INF) into third information (RES) is dependent on the authorization level (ALi) of the mammal (10) from which the biological sample is obtained, and/or wherein accessing the second information (DIAG-INF) and/or accessing the third information (RES) is dependent on the authorization level (ALi) of the mammal (10) from which the biological sample is obtained.

13. An authorization database (ADB) for processing information obtained from a biological sample (12) of a mammal (10), the authorization database being adapted to cooperate with an associated analyzing unit (AU) for analyzing information obtainable from the biological sample (12) of the mammal, the analyzing unit being adapted for extracting at least a first (ID-INF) and a second (DIAG-INF) information from the biological sample: a) the first information (ID-INF) being related to a personal identification of the mammal (10), the first information being extracted by genetic identification processing, and b) the second information (DIAG-INF) being related to the health and/or condition of the mammal (10), the authorization database (ADB) being arranged to receive the first information (ID-INF) from the analyzing unit (AU), the authorization database comprising corresponding sets of personal identification (IDi) of mammals and an authorization level (ALi) for each mammal (10), and the authorization database (ADB) further being arranged to cooperate with an associated processing unit (PU), said processing unit being arranged for receiving the second information (DIAG-INF) from the analyzing unit (AU) and processing the second information into third information (RES), wherein the processing of the second information (DIAG-INF) into third information (RES) is dependent on the authorization level (ALi) of the mammal (10) from which the biological sample is obtained, and/or wherein accessing the second information (DIAG-INF) and/or accessing the third information (RES) is dependent on the authorization level (ALi) of the mammal (10) from which the biological sample is obtained.

14. A method for processing information obtained from a biological sample (12) of a mammal (10), the method comprising: analyzing information obtainable from the biological sample (12) of the mammal in an analyzing unit (AU), the analyzing unit being adapted for extracting at least a first (ID-INF) and a second (DIAG-INF) information from the biological sample: a) the first information (ID-INF) being related to a personal identification of the mammal (10), the first information being extracted by genetic identification processing, and b) the second information (DIAG-INF) being related to the health and/or condition of the mammal (10), receiving the first information (ID-INF) from the analyzing unit (AU) in an authorization database (ADB), the authorization database comprising corresponding sets of personal identification (IDi) of mammals and an authorization level (ALi) for each mammal (10), and receiving the second information (DIAG-INF) from the analyzing unit (AU) in a processing unit (PU), said processing unit being arranged for processing the second information into third information (RES), wherein the processing of the second information (DIAG-INF) into third information (RES) is dependent on the authorization level (ALi) of the mammal (10) from which the biological sample is obtained, and/or wherein accessing the second information (DIAG-INF) and/or accessing the third information (RES) is dependent on the authorization level (ALi) of the mammal (10) from which the biological sample is obtained.

15. A computer program product being adapted to enable a computer system comprising at least one computer having data storage means associated therewith to control a system for processing information according to claim 14.