Diagnostic Kits

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  • Authors: Carolina Rossini, Andrew Clearwater and Mackenzie Cowell

Field Definition

add in Typology of Diagnostics

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

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

Research Vocabulary

The Paper

  1. Resources Used
  2. The Argument Framework
  3. Outline & Draft
  4. Genetic Diagnostics in Brief

Blog Post

  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


Relevant Manifestos & Declarations

Bibliography

  • 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.
  • 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].
  • 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.
  • Heller, M.A. & Eisenberg, R.A. Can patents deter innovation? The anticommons in biomedical research. Science 280, 698-701 (1998).
  • Hoag, H., 2004. Testing new ground. Nature, 429(6992), 682-3
  • 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].
  • Jensen, K. & Murray, F., 2005. INTELLECTUAL PROPERTY: Enhanced: Intellectual Property Landscape of the Human Genome. Science, 310(5746), 239-240.
  • Kalorama Information (Rosen). Diagnostic Test Service Commercialization: A Roadmap to Diagnostics in the 21st Century. (2008)
  • Kaye, J., Hawkins, N., and J. Taylor. (2007). Patents and translational research in genomics. Nature Biotechnology 25(7):739.
  • 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).
  • 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].
  • Merz, J.F., 2002. Patents limit medical potential of sequencing. Nature, 419(6910), 878.
  • Mills, A.E. & Tereskerz, P., 2008. DNA-based patents: an empirical analysis. Nat Biotech, 26(9), 993-995.
  • 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].
  • 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
  • Palombi. The Search for Alternatives to Patents in the 21st Century. (2009) pp. 1-42
  • 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.
  • Pressman, L. et al., 2006. The licensing of DNA patents by US academic institutions: an empirical survey. Nat Biotech, 24(1), 31-39
  • 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
  • *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
  • *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.
  • 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]
  • 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).
  • 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

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Blogs And News

News

  • GEN- Genetic Engineering & Biotechnology News: Clinical Research & Diagnostics Channel (http://www.genengnews.com/transmed/)
    Content includes News, Articles, Tutorials, & Conferences/Meetings

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