Myriad Genetics

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Myriad Genetics, Inc.
HeadquartersSalt Lake City, Utah
Key people
Paul J. Diaz, President and CEO
Mark Skolnick, Co-Founder
Peter Meldrum, Co-Founder
Kevin Kimberlin, Co-Founder
Jerry Lanchbury, CSO
Walter Gilbert, Director and Vice Chair
RevenueIncrease $690.6 Million(2021)[1]
Number of employees
2,600[2]
Websitewww.myriad.com

Myriad Genetics, Inc. is an American

precision medicine
), and measure disease activity.

History

The global search for the genetic basis of breast cancer began when

linkage analysis of a gene associated with increased risk for breast cancer (BRCA1) to the long arm of chromosome 17.[3]

To further locate the actual gene, Dr. Skolnick and his colleagues invented a gene mapping technique known as Restriction Fragment-length Polymorphisms (RFLP).[4] Gilbert joined Kimberlin in 1991, and they teamed up with Skolnick to form Myriad Genetics.[5]

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 sequenced BRCA1.[6] They attempted to patent this gene, which resulted in significant controversy and a landmark Supreme Court Case.[7][8][9]

The firm then established the first clinical laboratory to commercialize genomic testing.[10] [11] Myriad created the first test to measure the molecular biology and aggressiveness of men’s prostate cancer,[12] devised a method to assess the inherited breast cancer risk of any woman not previously diagnosed with breast cancer, regardless of ancestry, important for addressing racial and ethnic disparities,[13] commercialized a psychotropic test that covers 61 medications commonly prescribed for depression, anxiety, ADHD.[14] Also pioneering the field of DNA-specific medicine, Myriad received the first FDA approval for a lab-developed diagnostic test for use in predicting the responses to a DNA-repair drug.[15]

Acquisitions and Subsidiaries

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.[16]

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.[17]

Other subsidiaries of Myriad Genetics include Myriad International and Myriad Autoimmune (aka Crescendo Bioscience).[18]

Founders

The founders of Myriad are Peter Meldrum (past President and CEO of Agridyne and past CEO and President of Myriad Genetics, Inc.),

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).[19][20]

Products

Among the

hereditary cancers.[21]

Controversies

Myriad Genetics's patents on human genes became quite controversial.[22][23] Following the discovery by Mary-Claire King that a gene on chromosome 17 is associated with an increased risk of breast cancer,[3] Myriad attempted to patent this gene. These patents were the subject of scrutiny after Myriad became involved in a lawsuit over its patenting practices,[7][8][9] 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.[24] Additionally, the discovery of their relevance to breast cancer[25][26] was funded by the public.

Patent Lawsuits

In 2010-2013 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[27]
). Lawyers at the
genes related to breast cancer and ovarian cancer.[28]

Two of the company's patents on the

Supreme Court.[30] 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.[31]

On August 16, 2012, the Federal Circuit reaffirmed Myriad's right to patent the genes (because isolated genes are different from their natural state, using its own precedent 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.[35][36]

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.[37][38][39]

See also

References

  1. ^ "Myriad Genetics Reports Fourth Quarter 2021 Results, Provides Updates on Product Performance and Growth Initiatives". 24 February 2021.
  2. ^ "Myriad's Competitors, Revenue, Number of Employees, Funding, Acquisitions & News - Owler Company Profile".
  3. ^
    PMID 2270482
    .
  4. OCLC 28021657
    .
  5. OCLC 36138590
    .
  6. PMID 7545954
    .
  7. ^ a b c Begley, Sharon (29 March 2010). "In Surprise Ruling, Court Declares Two Gene Patents Invalid". Newsweek. Archived from the original on 19 April 2010. Retrieved 29 March 2010.
  8. ^ a b c Schwartz, John; Pollack, Andrew (29 March 2010). "Judge Invalidates Human Gene Patent". The New York Times. Retrieved 29 March 2010.
  9. ^ a b c "ACLU v. Myriad Genetics opinion" (PDF). 29 March 2010. Archived from the original (PDF) on 7 April 2010. Retrieved 30 March 2010.
  10. ^ "Xfin Health Information. Featured Customer: Myriad". XIFIN. 23 February 2017. Retrieved 16 November 2021.
  11. ISSN 0362-4331
    . Retrieved 16 November 2021.
  12. ^ Gross, Charles (7 October 2015). "Myriad Genetics, Tufts Health Plan Sign 3-Year Contract to Cover Prolaris for Members With Localized Prostate Cancer". Benzinga. Retrieved 16 November 2021.
  13. ^ "Myriad Genetics' RiskScore Accurately Identifies Breast Cancer Risk in Undiagnosed Women of All Ancestries". Cancer Network. 3 August 2021. Retrieved 16 November 2021.
  14. PMID 28515818
    .
  15. ^ "Myriad Receives FDA Approval of BRACAnalysis CDx® as Companion Diagnostic for Lynparza™ (olaparib) In Patients with Metastatic Breast Cancer | Myriad Genetics, Inc". investor.myriad.com. Retrieved 16 November 2021.
  16. ^ "Myriad to Acquire Assurex Health for up to $410M". 4 August 2016.
  17. ^ "Myriad Genetics Completes Acquisition of Counsyl". GenomeWeb. Retrieved 19 October 2018.
  18. ^ "Myriad Genetics and Subsidiary Locations and Directions". Myriad Genetics, Inc. Retrieved 16 November 2021.
  19. ^ "Breakthrough: The Race to Find the Breast Cancer Gene," page 199, by Kevin Davies and Michael White John Wiley & Sons.
  20. ISBN 978-1107011915
  21. ^ a b "Clinical Urologists Group Supports Genomic Testing for Prostate Cancer". ClinicalOMICs. 6 March 2018. Retrieved 9 March 2018.
  22. ^ Tamar Lewin (21 May 1996). "Move to Patent Cancer Gene Is Called Obstacle to Research". The New York Times. Retrieved 6 March 2014.
  23. ^ Pollack, Andrew (1 November 2010). "Gene Patent Ruling Raises Questions for Industry". The New York Times. Retrieved 6 March 2014.
  24. PMID 20393305
    .
  25. PMID 8460634
    .
  26. PMID 7545954
    .
  27. ^ "Association For Molecular Pathology et al v. United States Patent and Trademark Office et al". Justia.com. 12 May 2009.
  28. ^ "ACLU Challenges Patents on Breast Cancer Genes". American Civil Liberties Union. 6 June 2008.
  29. ^ "Myriad Applauds the Court of Appeals' Decision to Uphold Gene Patenting". Myriad Genetics. 29 July 2011. Retrieved 20 November 2011.
  30. ^ "Paper Chase: ACLU asks Supreme Court to rule on gene patent case". JURIST. 8 December 2011. Retrieved 6 March 2014.
  31. ^ Pollack, Andrew (26 March 2012). "Supreme Court Orders New Look at Gene Patents". The New York Times.
  32. ^ "Court Reaffirms Right of Myriad Genetics to Patent Genes". The New York Times. 16 August 2012.
  33. ^ "Myriad Genetics slips on Supreme Court review". Bloomberg Business Week. 3 December 2012. Archived from the original on 7 December 2012.
  34. ^ "Association for Molecular Pathology v. Myriad Genetics". ACLU. Retrieved 17 May 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.
  35. ^ Liptak, Adam (13 June 2013). "Supreme Court Rules Human Genes May Not Be Patented". The New York Times. Retrieved 13 June 2013.
  36. ^ Kendall, Brent; Bravin, Jess (13 June 2013). "Supreme Court Says Human Genes Aren't Patentable". Wall Street Journal. Retrieved 13 June 2013.
  37. ^ D'Arcy v Myriad Genetics Inc [2015] HCA 35.
  38. ^ Harrison, Dan (16 June 2015). "Genetic patents: Grandmother Yvonne D'Arcy takes on global giant Myriad Genetics". Sydney Morning Herald. Retrieved 14 October 2015.
  39. ^ Corderoy, Amy (7 October 2015). "Landmark High Court ruling on BRCA1 gene patent as pensioner wins legal case". Sydney Morning Herald. Retrieved 14 October 2015.

External links

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