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= [[Diagnostic Kits/Bibliography by Research Question | Bibliography by Research Question]] =  
= [[Diagnostic Kits/Bibliography by Research Question | Bibliography by Research Question]] =  


==Academic Articles and Papers==
*Caulfield, Timothy, 2009. Do Gene Patents Hurt Research? Available at: http://www.scienceprogress.org/2009/10/do-gene-patents-hurt-research/comment-page-1/#comment-6370
*Cho, M.K. et al., 2003. Effects of patents and licenses on the provision of clinical genetic testing services. The Journal of Molecular Diagnostics: JMD, 5(1), 3-8. Available at: http://jmd.amjpathol.org/cgi/content/full/5/1/3 [Accessed August 10, 2009].
**[[Diagnostic_Kits/Effects of patents and licenses on the provision of clinical genetic testing services|Highlights]]
*Cohen, W.M., Merrill, S.A. & Economy, N.R.C., 2003. Patents in the knowledge-based economy, National Academies Press.
**Cook-Deegan, R., Chandrasekharan, S. & Angrist, M., 2009. The dangers of diagnostic monopolies. Nature, 458(7237), 405-406.
**[[Diagnostic_Kits/The dangers of diagnostic monopolies|Highlights]]
*Eisenberg, R. Noncompliance, 2008. Nonenforcement, Nonproblem? Rethinking the Anticommons in Biomedical Research. Houston Law Review Available at: # www.houstonlawreview.org/archive/downloads/45-4_pdf/03_​Eisenberg.pdf [Accessed November 20, 2009].
**[[Diagnostic_Kits/Nonenforcement, Noneproblem Rethinking the Anticommons in Biomedical Research|Highlights]]
*Elfenbein, D.W., 2006. Publications, Patents, and the Market for University Inventions. SSRN eLibrary. Available at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=739227 [Accessed October 2, 2009].
* Farkas and Holland. Direct-to-consumer genetic testing: two sides of the coin. The Journal of molecular diagnostics : JMD (2009) vol. 11 (4) pp. 263-5. [Accessed 14 Dec 2009: http://jmd.amjpathol.org/cgi/content/full/11/4/263]
** [[Diagnostic_Kits/Direct-to-consumer genetic testing- two sides of the coin|Highlights]]
* Flockhart et al. Clinically Available Pharmacogenomics Tests. Clinical Pharmacology & Therapeutics (2009)  Available at: http://www.nature.com/clpt/journal/v86/n1/abs/clpt200939a.html
** [[Diagnostic_Kits/Clinically Available Pharmacogenomics Tests|Highlights]]
*Furness, et. al. The evaluation of diagnostic laboratory tests and complex biomarkers, (2008) Available at: http://www.phgfoundation.org/pages/work7.htm
*Garcia, L. & Shimizu, R., 1997. Evaluation of nine immunoassay kits (enzyme immunoassay and direct fluorescence) for detection of Giardia lamblia and Cryptosporidium parvum in human fecal specimens. J. Clin. Microbiol., 35(6), 1526-1529.
*Geertrui Van Overwalle et al., 2005. Models for facilitating access to patents on genetic inventions. Available at: http://www.nature.com/nrg/journal/v7/n2/full/nrg1765.html [Accessed August 10, 2009].
**[[Diagnostic_Kits/Models for facilitating access to patents on genetic inventions|Highlights]]
*Gibson, J., The Discovery of Invention: Gene Patents and the Question of Patentability. SSRN eLibrary. Available at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1347087 [Accessed October 29, 2009].
*Goodman et al. The Value of Diagnostics: Innovation, Adoption and Diffusion Into Health Care.  (2005) pp. 44-71.  Available at: http://www.advamed.org/MemberPortal/About/Resources/
** [[Diagnostic_Kits/The Value of Diagnostics: Innovation, Adoption and Diffusion Into Health Care|Highlights]]
*Hélène Dernis, 2007. Nowcasting Patent Indicators, OECD, Directorate for Science, Technology and Industry. Available at: http://ideas.repec.org/p/oec/stiaaa/2007-3-en.html.
*Heller, M.A. & Eisenberg, R.A. Can patents deter innovation? The anticommons in biomedical research. Science 280, 698-701 (1998).
*Henry, M. et al. 2002. DNA Patenting and Licensing Available at: http://www.bioethics.upenn.edu/prog/ethicsgenes/pdf/henry_etal_Science20020823.pdf [Accessed August 5, 2009].
**[[Diagnostic_Kits/DNA Patenting and Licensing|Highlights]]
*Henry, M.R., Cho, M.K., Weaver, M.A., Merz, J.F. A pilot survey on the licensing of DNA inventions. J. Law Med. Ethics, 31:442-449, 2003 Available at: http://www.bioethics.upenn.edu:16080/prog/ethicsgenes/ [Accessed September 10, 2009].
**[[Diagnostic_Kits/A pilot survey on the licensing of DNA inventions|Highlights]]
*Herder, M., Patents & the Progress of Personalized Medicine: Biomarkers Research as Lens. SSRN eLibrary. Available at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1435468 [Accessed October 1, 2009].
**[[Diagnostic Kits/Patents and the Progress of Personalized Medicine|Highlights]]
*Hoag, H., 2004. Testing new ground. Nature, 429(6992), 682-3
** [[Diagnostic_Kits/Testing new ground|Highlights]]
*Holman, Christopher M., The Impact of Human Gene Patents on Innovation and Access: A Survey of Human Gene Patent Litigation. UMKC Law Review, Vol. 76, p. 295, 2007. Available at SSRN: http://ssrn.com/abstract=1090562
*Holman, C.M., 2008. GENETICS: Trends in Human Gene Patent Litigation. Science, 322(5899), 198-199.
*J.D, M.A.H.P. & Munzer, S.R., Intellectual Property Rights in Genes and Gene Fragments: A Registration Solution for Expressed Sequence Tags. SSRN eLibrary. Available at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=241236 [Accessed October 30, 2009].
*Howlett, M.J. & Christie, A.F., An Analysis of the Approach of the European, Japanese and United States Patent Offices to Patenting Partial DNA Sequences (ESTs). SSRN eLibrary. Available at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=573184 [Accessed October 30, 2009].
*Huys et al. Legal uncertainty in the area of genetic diagnostic testing. NATURE BIOTECHNOLOGY (2009) vol. 27 (10) pp. 903-909.  Available at http://www.nature.com/nbt/journal/v27/n10/abs/nbt1009-903.html [accessed Nov 2 2009].
**[[Diagnostic_Kits/Legal uncertainty in the area of genetic diagnostic testing|Highlights]]
*J.D, M.A.H.P. & Munzer, S.R., Intellectual Property Rights in Genes and Gene Fragments: A Registration Solution for Expressed Sequence Tags. SSRN eLibrary. Available at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=241236 [Accessed October 30, 2009].
*Jensen, K. & Murray, F., 2005. INTELLECTUAL PROPERTY: Enhanced: Intellectual Property Landscape of the Human Genome. Science, 310(5746), 239-240. 
**[[Diagnostic_Kits/Intellectual Property Landscape of the Human Genome|Highlights]]
* Kalorama Information (Rosen). Diagnostic Test Service Commercialization: A Roadmap to Diagnostics in the 21st Century.  (2008)
** [[Diagnostic_Kits/Diagnostic Test Service Commercialization- A Roadmap to Diagnostics in the 21st Century|Highlights]]
*Kane, E., Molecules and Conflict: Cancer, Patents, and Women's Health. SSRN eLibrary. Available at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=960772 Accessed October 30, 2009.
*Kane, E., Patent-Mediated Standards in Genetic Testing. SSRN eLibrary. Available at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1495820 Accessed October 29, 2009.
*Kaye, J., Hawkins, N., and J. Taylor. (2007). Patents and translational research in genomics. Nature Biotechnology 25(7):739.
**[[Diagnostic_Kits/Patents and translational research in genomics|Highlights]]
*Kling. Diagnosis or drug? Will pharmaceutical companies or diagnostics manufacturers earn more from personalized medicine? EMBO reports (2007) vol. 8 (10) pp. 903-6. Accessed December 14, 2009 at http://www.nature.com/embor/journal/v8/n10/full/7401080.html
** [[Diagnostic Kits/Diagnosis or drug- Will pharmaceutical companies or diagnostics manufacturers earn more from personalized medicine|Highlights]]
*Laakmann, A. Restoring the Genetic Commons: A "Common Sense" Approach to Biotechnology Patent in Restoring the Genetic Commons, Michigan Telecommunications and Technology Law Review 14 MITTLR 43 (2007). 
*Lei et al. Patents versus patenting: implications of intellectual property protection for biological research. NATURE BIOTECHNOLOGY (2009) vol. 27 (1) pp. 36-40.  Available at: http://www.nature.com/nbt/journal/v27/n1/full/nbt0109-36.html
** [[Diagnostic_Kits/Patents versus patenting: implications of intellectual property protection for biological research|Highlights]]
*Macer, D.R.J., 2002. Patent or perish? An ethical approach to patenting human genes and proteins. The Pharmacogenomics Journal, 2(6), 361-366. Available at: http://www.nature.com/tpj/journal/v2/n6/full/6500140a.html [Accessed August 5, 2009].
*McGill Centre for Intellectual Property Policy, 2005, Biotechnology and Intellectual Property: Reinventing the Commons: Workshop Report. Available at: www.cipp.mcgill.ca/data/events/00000017_en.pdf [Accessed November 20, 2009].
**[[Diagnostic_Kits/Biotechnology and Intellectual Property Reinventing the Commons|Highlights]]
*Merz, J.F. et al., 2002. Diagnostic testing fails the test. Nature, 415(6872), 577-579.(Garcia & Shimizu 1997) Available at: http://repository.upenn.edu/bioethics_papers/48/ [Accessed August 5, 2009].
**[[Diagnostic_Kits/Diagnostic testing fails the test|Highlights]]
*Merz, J.F., 2002. Patents limit medical potential of sequencing. Nature, 419(6910), 878.
**[[Diagnostic_Kits/Patents limit medical potential of sequencing|Highlights]]
*Merz, J.F., 1999. Disease Gene Patents: Overcoming Unethical Constraints on Clinical Laboratory Medicine. Clin Chem, 45(3), 324-330.(Merz 1999) Available at: http://www.clinchem.org/cgi/content/abstract/45/3/324 [Accessed August 5, 2009].
**[[Diagnostic_Kits/Disease Gene Patents|Highlights]]
*Mills, A.E. & Tereskerz, P., 2008. DNA-based patents: an empirical analysis. Nat Biotech, 26(9), 993-995. 
**[[Diagnostic_Kits/DNA-based patents: an empirical analysis|Highlights]]
*Mills, A.E. & Tereskerz, P.M., 2007. Changing patent strategies: what will they mean for the industry? Nat Biotech, 25(8), 867-868.
*Morrison & Foerster : Legal Updates & News : Press Releases : Morrison & Foerster Represents ACON Laboratories in $175 Million Acquisition by Inverness Medical Innovations, Resolving Patent Litigation Between the Two Companies Over Rapid Diagnostic Techno. Available at: http://www.mofo.com/news/media/files/pr02058.html [Accessed August 5, 2009].
**[[Diagnostic_Kits/Morrison and Foerster Represents ACON Laboratories in $175 Million Acquisition by Inverness Medical Innovations|Highlights]]
*Mueller, J.M., Public Access Versus Proprietary Rights in Genomic Information: What Is the Proper Role of Intellectual Property Rights? SSRN eLibrary. Available at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1367849 [Accessed October 30, 2009].
*Muller, A et. al., Protecting Biotechnological Inventions in Brazil and Abroad: Draft, Scope and Protecting Biotechnological Inventions in Brazil and Abroad: Draft, Scope, and Interpretation of Claims 2002, Albany Law Journal of Science and Technology, 13 ALBLJST 145 (2002). 
*Nelson. The market economy, and the scientific commons. Research Policy (2004) vol. 33 (3) pp. 455-471
** [[Diagnostic_Kits/The market economy, and the scientific commons|Highlights]]
*Ouellette, L.L., Access to Bio-Knowledge: From Gene Patents to Biomedical Materials. SSRN eLibrary. Available at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1431580 [Accessed October 29, 2009].
*Palombi. The Search for Alternatives to Patents in the 21st Century.  (2009) pp. 1-42
** [[Diagnostic_Kits/The Search for Alternatives to Patents in the 21st Century|Highlights]]
*Paradise, J., European Opposition to Exclusive Control Over Predictive Breast Cancer Testing and the Inherent Implications for United States Patent Law and Public Policy: A Case Study of the Myriad Genetics' BRCA Patent Controversy. SSRN eLibrary. Available at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=897507 [Accessed October 30, 2009].
*Phillips, K.a., Van Bebber, S. & Issa, A.M., 2006. Diagnostics and biomarker development: priming the pipeline. Nature reviews. Drug discovery, 5(6), 463-9.
** [[Diagnostic_Kits/Diagnostics and biomarker development- priming the pipeline|Highlights]]
*Palombi, L. The Search for Alternatives to Patents in the 21st Century.  (2009)  Available at http://cgkd.anu.edu.au/menus/publications.php#palombi
** [[Diagnostic_Kits/The Search for Alternatives to Patents in the 21st Century|Highlights]]
*Pressman, L. et al., 2006. The licensing of DNA patents by US academic institutions: an empirical survey. Nat Biotech, 24(1), 31-39
**[[Diagnostic_Kits/The licensing of DNA patents by US academic institutions|Highlights]]
*Priorities for Personalized Medicine, Council of Advisors on Science and Technology (PCAST), September 2008 Available at: http://www.ostp.gov/galleries/PCAST/pcast_report_v2.pdf
**[[Diagnostic_Kits/Priorities for Personalized Medicine|Highlights]]
*Saez, C., Changing Winds For Gene Patenting In the US? Stakeholders React To Draft Report, October 2009 Available at: http://www.ip-watch.org/weblog/2009/10/29/changing-winds-for-gene-patenting-in-the-us-stakeholders-react-to-draft-report/
*Shapiro, C., Navigating the Patent Thicket: Cross Licenses, Patent Pools, and Standard-Setting, 2001, Innovation Policy and the Economy (Vol. I) (Jaffe, Adam B. et al., eds), pp. 119-150, MIT Press Available at: http://faculty.haas.berkeley.edu/shapiro/thicket.pdf [Accessed December 6, 2009]
*Torrance, A.W., Patenting Human Evolution. SSRN eLibrary. Available at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1300615 [Accessed October 30, 2009].
*Verbeure, B. et al., 2006. Patent pools and diagnostic testing. Trends in Biotechnology, 24(3), 115-120.(Verbeure et al. 2006) Available at: http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6TCW-4J4HK5P-1&_user=10&_rdoc=1&_fmt=&_orig=search&_sort=d&_docanchor=&view=c&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=8c0fd5a6f1431a3cbfc9ff2f37470c3b [Accessed August 8, 2009].
**[[Diagnostic_Kits/Patent pools and diagnostic testing|Highlights]]
*Verbeure, B., Matthijs, G. & Van Overwalle, G., 2005. Analysing DNA patents in relation with diagnostic genetic testing. Eur J Hum Genet, 14(1), 26-33. Available at: http://www.nature.com/ejhg/journal/v14/n1/full/5201503a.html [Accessed August 11, 2009].
**[[Diagnostic_Kits/Analysing DNA patents in relation with diagnostic genetic testing|Highlights]]
*Walsh JP, Arora A, Cohen WM. Effects of research tool patents and licensing on biomedical innovation. In: Cohen WM, Merrel SA, (editors). Patents in the knowledge-based economy. Washington (DC): The National Academies Press; 2003. p. 285-340.
*Walsh, J. , Cho, C. & Cohen, W.M. Patents, Material Transfers and Access to Research Inputs in Biomedical Research (Final Report to the National Academy of Sciences' Committee [on] Intellectual Property Rights in Genomic and Protein-Related Research Inventions, 20 September 2005).
*Walters, L., 2006. Professor Examines Licensing of DNA Patents Available at: http://www.genome.gov/Pages/Newsroom/NHGRIRelatedReleases/LicensingofDNAPatents.pdf [Accessed August 5, 2009].
*Wilson et al., Biomarker Development, Commercialization, and Regulation: Individualization of Medicine Lost in Translation, 81 Clinical Pharmacology & Therapeutics 153 (2007).
*Wolrad Prinz zu Waldeck und Pyrmont, Research Tool Patents After Integra v. Merck—Have They Reached a Safe Harbor?, 14 Mich. Telecomm. Tech. L. Rev. 367 (2008), available at http://www.mttlr.org/volfourteen/waldeck.pdf
==Blogs & Social Media==
=== Blogs ===
*'''Genomics Law Report''' (http://www.genomicslawreport.com/)
*: "News and analysis from the intersection of genomics, personalized medicine and the law"
*: [http://www.genomicslawreport.com/index.php/2009/09/30/ncis-new-brca1-test-broader-utility-and-another-challenge-to-traditional-genetic-tests/ NCI’s New BRCA1 Test: Broader Utility and Another Challenge to Traditional Genetic Tests]
*: [http://www.genomicslawreport.com/index.php/2009/08/13/is-the-accps-call-for-greater-governmental-regulation-of-dtc-genetics-premature/ Is the ACCP’s Call for Greater Governmental Regulation of DTC Genetics Premature?]
*'''Patent Docs''' (http://www.patentdocs.org/)
*: "Biotech & Pharma Patent Law & News Blog"
*: [http://www.patentdocs.org/2009/11/supreme-court-bilski-argument.html Supreme Court Bilski Argument]
*'''Holman's Biotech IP Blog''' (http://holmansbiotechipblog.blogspot.com/)
*: "University of Missouri-Kansas City School of Law Professor's analysis and commentary on the intersection of biotechnology and intellectual property.
=== Twitter ===
http://twitter.com/100ideas/geneticdx - 8 experts on genetic/genomic diagnostics and personalized medicine
=== News ===
*'''GEN- Genetic Engineering & Biotechnology News: Clinical Research & Diagnostics Channel''' (http://www.genengnews.com/transmed/)
*: Content includes News, Articles, Tutorials, & Conferences/Meetings
*'''PGx News - Information Portal for Pharmacogenomics''' (http://www.pgxnews.org/web/)
*: Pharmacogenomics news, updated daily
==Business Association' Publications==
*The Economic Impact of Licensed Commercialized Inventions Originating in University Research, 1996-2007, Biotechnology Industry Organization (BIO) Available at http://www.bio.org/ip/techtransfer/BIO_final_report_9_3_09_rev_2.pdf.
==Civil Society Organizations Publications==
*American Civil Liberties Union : BRCA: Genes and Patents. Available at: http://www.aclu.org/freespeech/gen/39556res20090512.html [Accessed August 5, 2009].
== Declarations and Manifestos==
*[[Nature on Open Data]]
*[[The Manchester Manifesto]]
==Governmental Resources and Reports==
* Australian Law Reform Commission. Genes and ingenuity: gene patenting and human health report.  (2004) pp. 678.  Available at http://www.austlii.edu.au/au/other/alrc/publications/reports/99/.  Accessed 27 Jan 2010
** [[/Genes and ingenuity: gene patenting and human health report.|Highlights]]
* Ayme et al. Patenting and licensing in genetic testing: recommendations of the European Society of Human Genetics. European Journal of Human Genetics (2008) vol. 16 Suppl 1 pp. S10-9
** [[/Patenting and licensing in genetic testing: recommendations of the European Society of Human Genetics|Highlights]]
*Esther van Zimmeren et al. 2006.Bulletin of the World Health Organization - A clearing house for diagnostic testing: the solution to ensure access to and use of patented genetic inventions? Available at: http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S0042-96862006000500013 [Accessed August 10, 2009].
**[[Diagnostic_Kits/A clearing house for diagnostic testing: the solution to ensure access to and use of patented genetic inventions|Highlights]]
*National Institutes of Health (NIH), Public Health Service, DHHS, NIH Principles and Guidelines for Sharing of Biomedical Resources -- Final (December 1999) Available at: http://www.ott.nih.gov/policy/research_tool.aspx
**[[Diagnostic_Kits/NIH Principles and Guidelines for Sharing of Biomedical Resources|Highlights]]
*National Research Council of the National Academies — Committee on Intellectual Property Rights in Genomic and Protein Research and Innovation. Reaping the benefits of genomic and proteomic research: intellectual property rights, innovation, and public health. Washington (DC): The National Academies Press; 2005. Available from http://www.nap.edu/catalog/11487.html, Also Available from: http://books.google.com/books?id=crZWVfYNmtgC&lpg=PP1&ots=jaiZTMGZOU&dq=Reaping%20the%20Benefits%20of%20Genomic%20and%20Proteomic%20Research%3A%20Intellectual%20Property%20Rights%2C%20Innovation%2C%20and%20Public%20Health&pg=PP1#v=onepage&q=&f=false
*Secretary's Advisory Committee on Genetics, Health, and Society—Public Consultation Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests (Draft Report for Public Comment) [excerpts]. Biotechnology Law Report, 28(3), 417-442 (2009). Available at: http://oba.od.nih.gov/SACGHS/sacghs_documents.html#GHSDOC_011
**[[Diagnostic_Kits/SACGHS_Gene_Patents_and_Licensing_Practices|Highlights]]
*'''*Secretary's Advisory Committee on Genetics, Health, and Society—Public Consultation Final Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests - September 17, 2009'''
**[[Diagnostic_Kits/SACGHS_Gene_Patents_and_Licensing_Practices_Final_Report|Highlights]]
*'''*Secretary's Advisory Committee on Genetics, Health, and Society—Public Consultation Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests - Appendix 1: Compendium of Case Studies on the Impact of Gene Patents and Licensing Practices on Access to Genetic Testing.  (2009) Available at: http://oba.od.nih.gov/SACGHS/sacghs_documents.html#GHSDOC_011.'''
** [[SACGHS Appendix 1- Compendium of Case Studies on the Impact of Gene Patents and Licensing Practices on Access to Genetic Testing|highlights]]
*'''*Secretary’s Advisory Committee on Genetics, Health, and Society, U.S. System of Oversight of Genetic Testing: A Response to the Charge of the Secretary of Health and Human Services, April 2008. Available at: http://oba.od.nih.gov/oba/SACGHS/reports/SACGHS_oversight_report.pdf [Accessed July 8, 2009].'''
**[[Diagnostic_Kits/SACGHS_U.S. System of Oversight of Genetic Testing|Highlights]]
==Market Reports==
*Diagnostic Test Service Commercialization in Multiplex and Esoteric Testing: A Roadmap to Diagnostics in the 21st Century - market research report. Available at: http://www.reportlinker.com/p091997/Diagnostic-Test-Service-Commercialization-in-Multiplex-and-Esoteric-Testing-A-Roadmap-to-Diagnostics-in-the-21st-Century.html?utm_source=LivePR&utm_medium=pr&utm_campaign=LivePR [Accessed August 6, 2009]. 
**[[Diagnostic_Kits/Diagnostic Test Service Commercialization in Multiplex and Esoteric Testing|Highlights]]
==Newspapers and Opinions==
*NanoLogix Provides Operations Update and Notification of Shareholder Meeting - FOXBusiness.com. Available at: http://www.foxbusiness.com/story/markets/industries/health-care/nanologix-provides-operations-update-notification-shareholder-meeting/ [Accessed August 5, 2009].
==Databases and Statistics and Patents==
*DPD: DNA Patent Database. Available at: http://dnapatents.georgetown.edu/ [Accessed August 10, 2009].
*World Patent Report: A Statistical Review 2008 Available at: http://www.wipo.int/ipstats/en/statistics/patents/wipo_pub_931.html
=[[Diagnostic_Kits/Interviews|Interviews]]=
''' Completed '''
* [[Diagnostic_Kits/Interviews#Mark_Redmond_.28via_LinkedIn.29|Mark Redmond (via LinkedIn)]]
* [[Diagnostic_Kits/Interviews#Andrew Torrance|Andrew Torrance]]
'''Recommended'''
*[[http://74.125.95.132/search?q=cache:0AOgd7fUn38J:law.shu.edu/uploads/faculty/paradise_cv.pdf+Prof+Jordan+Paradise+at+Seton+Hall+Law&cd=1&hl=en&ct=clnk&gl=us|Prof Jordan Paradise]] at Seton Hall Law
*[[http://www.law.ucla.edu/home/index.asp?page=571|Russ Korobkin]] at UCLA
''' Upcoming? '''
* Jason Bobe
* Dr. Joe Thakuria


=Navigation=
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Revision as of 14:43, 17 April 2010

  • Authors: Carolina Rossini, Andrew Clearwater and Mackenzie Cowell

Field Definition

What are Genetic Diagnostics?

Definitions

We're interested in studying genetic diagnostics (GDx). GDx are clinical diagnostics based on the analysis of human DNA to determine genotype and corresponding health states, such as disease diagnosis, prognosis, recurrence, and differential drug response. (see SACGHS Patent report, pg 5).

GDx are often classified as molecular diagnostics (or esoteric tests), a category of relatively novel diagnostics based on biochemistry developed over the last 30 years. Molecular diagnostics analyze molecular components of the body, such DNA, RNA, proteins, and some small molecules. Importantly, while other standard diagnostics, such as immunochemistry tests, may in fact be based on molecular techniques, the are generally not classified as molecular diagnostics. Molecular diagnostics typically test for rare or unusual health conditions and are more sophisticated or involve increased complexity and human involvement than routine tests, although molecular tests are becoming more routine.

Molecular diagnostics are a kind of In-Vitro Diagnostic (IVD). (Other classes of IVDs are General/Clinical chemistry, Immunochemistry, Hematology/Cytology, Microbiology/Infectious Disease, & Molecular, Genomic, Proteomic, & Metabolomics).

Research Vocabulary

Under this section, you can find a variety of key concepts related to the Diagnostic Kits sector and relevant to its understanding.

What's the market like?

Although market data is readily available for molecular / esoteric diagnostics, it usually is not broken into further sub-categories, making it difficult to find market information specifically for genetic tests.

Currently there are genetic tests clinically available for over 1574 diseases according to genetests.org.

The SACGHS Oversight report (pg 65) describes the two paths genetic diagnostics typically follow from the research bench to clinical practice: a complete in vitro diagnostic kit may be developed and sold commercially to multiple laboratories, or laboratories may develop and validate a test solely for use internally, often with the use of analyte-specific reagents; these tests are called laboratory-developed tests (LDTs). The two paths are subject to different regulatory requirements; generally, IVD kits are more stringently regulated by FDA, which considers kits as in vitro diagnostic devices and may require premarket review or approval.

Both types of diagnostic, IVDs and LDTs, must be analyzed in CLIA-certified labs. Clearing FDA premarket review or approval is generally much more resource-intensive than developing an LDT, so new discoveries are often find their way to market first as LDTs. A third kind of genetic diagnostic product has developed over the last decade: direct-to-consumer (DTC) genetic tests. Most are ignored clinically are are often derided by medical professionals as "recreational genomics." [1]

Who sells genetic diagnostics?

Where are genetic diagnostic products, be they IVDs, LDTs, or DTC tests, developed, produced, and used?

I don't have any solid archetypal examples of GDx development from the 3 categories, which is to say, I don't fully understand how basic research, often consisting of genotype-phenotype association studies, is turned into a new diagnostic product.

Who produces existing tests? As far as I can tell, there are two main national testing providers, which resell smaller company's IVDs as kits, produce their own IVD kits, and offer a variety of LDTs, as well as thousands of smaller CLIA-certified labs operating independently and in association with hospitals and doctors offices and offering a subset of the services.

The two largest national independent clinical laboratories, Quest Diagnostics and LabCorp, sold 2.78 billion worth of genetic & esoteric tests in 2008 (from annual reports; not clear if that revenue is from IVDs or LDTs or both).

The most prominent DTC companies operate their own CLIA-certified labs. Users purchase the test, use a sampling kit at home (often a buccal swab), and mail the sample kit to the DTC company's lab, which is where the test is conducted. Results are shared online or via a counselor retained by the company. Physicians are often not involved, unlike other GDx products.

So besides DTC products, which are used at home, in most cases samples are collected at a Doctor's office or at a hospital and then sent to an independent testing provider, either one of the two main reference lab or a smaller-CLIA lab.

The Development Pipeline

still working on this

References

  1. ↑ Medical vs. “Recreational” Genomics: Drawing a Line in the Sand - Genomics Law Report

Essay

  1. Page for Joint Creation of Blog Post

Study of the field

Analysis of the field with basis on Field Research Methodology

  1. Overview of Economics of Intellectual Property in Kits
  2. Give an overall picture of the Kits' sector
  3. Outputs and Products of the field: data, narratives and tools produced by the Kits' sector
  4. Legal tools available for and in use by the actors of Kits' sector: IP in Kits
  5. competitive advantages in Kits
  6. IP Profile of Biggest for-profit companies in Kits
  7. IP Profile of non-profit companies in Kits
  8. IP Profile of Universities working in Kits
  9. IP Profile of Associations in Kits
  10. Commons based cases in Kits
  11. Peer-Production Business models in Kits
  12. Open Business models in Kits

The Paper

  1. Resources Used
  2. The Argument Framework
  3. Outline & Draft
    1. The impact of Case Law in shaping Diagnostics' Patents

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