Myriad Genetics

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Myriad Genetics, Inc.
TypePublic
NasdaqMYGN
S&P 600 Component
IndustryHealthcare
Molecular Diagnostics
Biotechnology
Precision Medicine
FoundedSalt Lake City, Utah, United States (1991)
HeadquartersSalt Lake City, Utah
Key people
Paul J. Diaz, President and CEO
Mark Skolnick, Co-Founder
Peter Meldrum, Co-Founder
Jerry Lanchbury, CSO
Walter Gilbert, Director and Vice Chair
RevenueIncrease $636.8 Million(2020)[1]
Number of employees
2,600[2]
Websitewww.myriad.com

Myriad Genetics, Inc. is an American molecular diagnostic company based in Salt Lake City, Utah, United States. Myriad employs a number of proprietary technologies that permit doctors and patients to understand the genetic basis of human disease and the role that genes play in the onset, progression and treatment of disease. This information is used to guide the development of new molecular diagnostic products that assess an individual's risk for developing disease later in life (predictive medicine), identify a patient's likelihood of responding to a particular drug therapy (precision medicine), assess a patient's risk of disease progression and disease recurrence (precision medicine), and measure disease activity.

History[edit]

The global search for the genetic basis of breast cancer began in April 1978 [3] when Dr. Mark Skolnick began his research on family disease and linkages at the University of Utah. Numerous other groups also worked to locate BRCA, including Mary-Claire King, Ph.D., from the University of California, Berkeley where she announced the localization through linkage analysis of a gene associated with increased risk for breast cancer (BRCA1) to the long arm of chromosome 17. [4]

In August 1994, Mark Skolnick and researchers at Myriad, along with colleagues at the University of Utah, the U.S National Institutes of Health (NIH), and McGill University patented and sequenced BRCA1.[5]

Acquisitions and Subsidiaries[edit]

In August 2016, Myriad announced it would acquire Assurex Health for up to $410 million, expanding the company's genetic testing for psychotropic medicine selection.[6]

In July 2018, Myriad completed an acquisition of reproductive genetic testing firm Counsyl for $375 million, expanding the company's testing capabilities to carrier and prenatal screening.[7]

Founders[edit]

The founders of Myriad are Peter Meldrum (past President and CEO of Agridyne and past CEO and President of Myriad Genetics, Inc.), Kevin Kimberlin (Chairman of Spencer Trask & Co.), Dr. Walter Gilbert (Founder of Biogen) and Mark Skolnick (Adjunct Professor in the Department of Medical Informatics at the University of Utah).[8][9]

Subsidiaries[edit]

Subsidiaries of Myriad Genetics include Myriad Genetic Laboratories, Inc., Myriad RBM, Sividon Diagnostics, Assurex Health, and, most recently, Counsyl.[citation needed]

Products[edit]

Among the prognostic tests developed and marketed by Myriad is "Prolaris", which uses gene expression profiling to provide a 10-year prostate cancer-specific risk of death.[10] Another prognostic test, marketed as "myRisk Hereditary Cancer", reviews genetic markers correlated with elevated risk of developing any of eight hereditary cancers.[10]

Controversies[edit]

Myriad Genetics's patents on human genes became quite controversial.[11][12] Following the discovery by Mary-Claire King that a gene on chromosome 17 is associated with an increased risk of breast cancer,[4] Myriad attempted to patent this gene. These patents were the subject of scrutiny after Myriad became involved in a lawsuit over its patenting practices,[13][14][15] which led to the landmark Supreme Court decision Association for Molecular Pathology v. Myriad Genetics, Inc. which ruled these patents illegal. Because genes occur naturally in every human, in addition to raising moral questions, some believe that patents constitute an obstacle to biomedical research worldwide.[16] Additionally, the discovery of their relevance to breast cancer[17][18] was funded by the public.

USA: Association for Molecular Pathology v. Myriad Genetics (2013)[edit]

Myriad Genetics was a defendant in the case Association for Molecular Pathology v. Myriad Genetics (formerly Association For Molecular Pathology et al. v. United States Patent and Trademark Office[19]). Lawyers at the ACLU served as counsel for the plaintiffs. In the suit, medical associations, doctors, and patients sued Myriad Genetics to challenge seven United States patents on genes related to breast cancer and ovarian cancer.[20]

Two of the company's patents on the BRCA1 and BRCA2 genes were ruled invalid on March 29, 2010, by Judge Robert W. Sweet in the U.S. District Court for the Southern District of New York.[13][14][15] On appeal, the Court of Appeals for the Federal Circuit reversed the trial court in an opinion dated July 29, 2011 and held that the genes were eligible for patents.[21]

On December 7, 2011, the ACLU filed a petition for a writ of certiorari to the Supreme Court.[22] On March 26, 2012, the Supreme Court vacated the Federal Circuit's judgment and remanded the case for further consideration in light of Mayo Collaborative Services v. Prometheus Laboratories, Inc., in which the Supreme Court had ruled, just six days earlier, that more restrictive rules were required to patent observations about natural phenomena.[23]

On August 16, 2012, the Federal Circuit reaffirmed Myriad's right to patent the genes although they denied rights to patent comparisons of DNA sequences.[24] On November 30, 2012, the Supreme Court agreed to hear a second challenge to the two gene patents held by Myriad.[25] Oral argument took place on April 15, 2013.[26] On June 13, 2013, in Association for Molecular Pathology v. Myriad Genetics (No. 12-398), the US Supreme Court unanimously ruled that "A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated", invalidating Myriad's patents on the BRCA1 and BRCA2 genes. However, the Court also held that manipulation of a gene to create something not found in nature—such as a strand of synthetically-produced complementary DNA (cDNA)—could still be eligible for patent protection.[27][28]

Myriad Genetics has also been involved in litigation in Australia over the patentability of DNA sequences (D'Arcy v Myriad Genetics Inc (2015)). Regarding BRCA1, the company succeeded in the Federal Court, both at first instance and on appeal to the full court, but in October 2015 lost in a unanimous decision of the High Court, D'Arcy v Myriad Genetics Inc.[29][30][31]

See also[edit]

References[edit]

  1. ^ "Myriad Genetics Q4 Revenues Plummet 57 Percent on Coronavirus Pandemic Pressures". 13 August 2020.
  2. ^ https://www.owler.com/company/myriad
  3. ^ Davies, Kevin; White, Michael (1996). Breakthrough: The Race to Find the Breast Cancer Gene. Wiley. pp. Page 190 Quote from Jon Hill, a University of Utah graduate student who was at the April 1978 scientific retreat in Alta Utah.
  4. ^ a b Hall, J.; Lee, M.; Newman, B.; Morrow, J.; Anderson, L.; Huey, B.; King, M. (1990). "Linkage of early-onset familial breast cancer to chromosome 17q21". Science. 250 (4988): 1684–1689. doi:10.1126/science.2270482. PMID 2270482.
  5. ^ Miki, Y.; Swensen, J.; Shattuck-Eidens, D.; Futreal, P. A.; Harshman, K.; Tavtigian, S.; Liu, Q.; Cochran, C.; Bennett, L. M.; Ding, W.; Et, A. (1994). "A strong candidate for the breast and ovarian cancer susceptibility gene BRCA1". Science. 266 (5182): 66–71. doi:10.1126/science.7545954. PMID 7545954.
  6. ^ "Myriad to Acquire Assurex Health for up to $410M". 2016-08-04.
  7. ^ "Myriad Genetics Completes Acquisition of Counsyl". GenomeWeb. Retrieved 2018-10-19.
  8. ^ "Breakthrough: The Race to Find the Breast Cancer Gene," page 199, by Kevin Davies and Michael White John Wiley & Sons.
  9. ^ Ghosh, Shubha "Identity, Invention, and the Culture of Personalized Medicine Patenting", Cambridge University Press, September 10, 2012, Pages 41 and 42, ISBN 978-1107011915
  10. ^ a b "Clinical Urologists Group Supports Genomic Testing for Prostate Cancer". ClinicalOMICs. March 6, 2018. Retrieved March 9, 2018.
  11. ^ Tamar Lewin (1996-05-21). "Move to Patent Cancer Gene Is Called Obstacle to Research". Nytimes.com. Retrieved 2014-03-06.
  12. ^ Pollack, Andrew (November 1, 2010). "Gene Patent Ruling Raises Questions for Industry". The New York Times. Retrieved 2014-03-06.
  13. ^ a b Begley, Sharon (March 29, 2010). "In Surprise Ruling, Court Declares Two Gene Patents Invalid". Newsweek. Archived from the original on April 19, 2010. Retrieved March 29, 2010.
  14. ^ a b Schwartz, John; Pollack, Andrew (March 29, 2010). "Judge Invalidates Human Gene Patent". The New York Times. Retrieved March 29, 2010.
  15. ^ a b "ACLU v. Myriad Genetics opinion" (PDF). 2010-03-29. Archived from the original (PDF) on 2010-04-07. Retrieved 2010-03-30.
  16. ^ Cook-Deegan, Robert; Derienzo, Christopher; Carbone, Julia; Chandrasekharan, Subhashini; Heaney, Christopher; Conover, Christopher (2010-03-01). "Impact of gene patents and licensing practices on access to genetic testing for inherited susceptibility to cancer: Comparing breast and ovarian cancers with colon cancers". Genetics in Medicine. 12 (4): S15–18, S20–24, S27–28. doi:10.1097/GIM.0b013e3181d5a67b. PMC 3047448. PMID 20393305.
  17. ^ Easton DF, Bishop DT, Ford D, Crockford GP (2014-01-24). "Genetic linkage analysis in familial breast and ovarian cancer: results from 214 families. The Breast Cancer Linkage Consortium". Am. J. Hum. Genet. 52 (4): 678–701. PMC 1682082. PMID 8460634.
  18. ^ Miki, Y.; Swensen, J.; Shattuck-Eidens, D.; Futreal, P.; Harshman, K.; Tavtigian, S.; Liu, Q.; Cochran, C.; Bennett, L.; Ding, W.; Et, al. (1994-10-07). "A strong candidate for the breast and ovarian cancer susceptibility gene BRCA1". Science. 266 (5182): 66–71. doi:10.1126/science.7545954. PMID 7545954.
  19. ^ "Association For Molecular Pathology et al v. United States Patent and Trademark Office et al". Justia.com. May 12, 2009.
  20. ^ "ACLU Challenges Patents on Breast Cancer Genes". American Civil Liberties Union. June 6, 2008.
  21. ^ "Myriad Applauds the Court of Appeals' Decision to Uphold Gene Patenting". Myriad Genetics. 2011-07-29. Retrieved 2011-11-20.
  22. ^ "Paper Chase: ACLU asks Supreme Court to rule on gene patent case". JURIST. 2011-12-08. Retrieved 2014-03-06.
  23. ^ Pollack, Andrew (March 26, 2012). "Supreme Court Orders New Look at Gene Patents". The New York Times.
  24. ^ "Court Reaffirms Right of Myriad Genetics to Patent Genes". The New York Times. August 16, 2012.
  25. ^ "Myriad Genetics slips on Supreme Court review". Bloomberg Business Week. December 3, 2012.
  26. ^ "Association for Molecular Pathology v. Myriad Genetics". ACLU. Retrieved May 17, 2013. On May 12, 2009, the ACLU and the Public Patent Foundation (PUBPAT) filed a lawsuit charging that patents on two human genes associated with breast and ovarian cancer, BRCA1 and BRCA2, are unconstitutional and invalid. On November 30, 2012, the Supreme Court agreed to hear argument on the patentability of human genes. The ACLU argued the case before the U.S. Supreme Court on April 15, 2013. We expect a decision this summer.
  27. ^ Liptak, Adam (June 13, 2013). "Supreme Court Rules Human Genes May Not Be Patented". The New York Times. Retrieved June 13, 2013.
  28. ^ Kendall, Brent; Bravin, Jess (June 13, 2013). "Supreme Court Says Human Genes Aren't Patentable". Wall Street Journal. Retrieved June 13, 2013.
  29. ^ D'Arcy v Myriad Genetics Inc [2015] HCA 35.
  30. ^ Harrison, Dan (June 16, 2015). "Genetic patents: Grandmother Yvonne D'Arcy takes on global giant Myriad Genetics". Sydney Morning Herald. Retrieved October 14, 2015.
  31. ^ Corderoy, Amy (October 7, 2015). "Landmark High Court ruling on BRCA1 gene patent as pensioner wins legal case". Sydney Morning Herald. Retrieved October 14, 2015.

External links[edit]