Myriad Genetics

Myriad Genetics, Inc.

Company type	Public
Traded as	Nasdaq: MYGN S&P 600 Component
Industry	Healthcare Molecular Diagnostics Biotechnology Precision Medicine
Founded	1991; 34 years ago (1991), in Salt Lake City, Utah, United States
Founder	Mark Skolnick Peter Meldrum
Headquarters	Salt Lake City, Utah
Key people	Paul J. Diaz (president and CEO) Jerry Lanchbury (CSO) Walter Gilbert (director and vice chair)
Revenue	$690.6 Million(2021)[1]
Number of employees	2,600[2]
Website	myriad.com

Myriad Genetics, Inc. is an American genetic testing and precision medicine 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 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

The global search for the genetic basis of breast cancer began when Mary-Claire King, Ph.D., from the University of California, Berkeley announced the localization through 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.) and Mark Skolnick (Adjunct Professor in the Department of Medical Informatics at the University of Utah).^[19][20]

Products

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.^[21] Another prognostic test, marketed as "myRisk Hereditary Cancer", reviews genetic markers correlated with elevated risk of developing any of eleven 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 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.^[28]

Two of the company's patents on the BRCA1 and BRCA2 genes, which are inherited gene mutations that link to around half of the 5%-10% of inherited gene mutating breast cancer cases in the U.S^[27], 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.^[7][8][9] 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.^[29] On December 7, 2011, the ACLU filed a petition for a writ of certiorari to 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 Amgen v. Chugai Pharmaceutical), although they denied patent claims on methods comprising comparison of DNA sequences, as unpatentable "mental acts".^[32] On November 30, 2012, the Supreme Court agreed to hear a second challenge to the two gene patents held by Myriad.^[33] Oral argument took place on April 15, 2013.^[34] 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.^[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

• Biological patents in the United States

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. 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. Bibcode:1990Sci...250.1684H. doi:10.1126/science.2270482. PMID 2270482.
4. Cook-Deegan, Robert M. (1994). The gene wars : science, politics, and the human genome. New York: W.W. Norton & Co. ISBN 0-393-03572-7. OCLC 28021657.
5. Davies, Kevin (1995). Breakthrough : the quest to isolate the gene for hereditary breast cancer. Michael White. London: Macmillan. pp. 199–200. ISBN 0-333-61102-0. OCLC 36138590.
6. 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. Bibcode:1994Sci...266...66M. doi:10.1126/science.7545954. PMID 7545954.
7. 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. Schwartz, John; Pollack, Andrew (29 March 2010). "Judge Invalidates Human Gene Patent". The New York Times. Retrieved 29 March 2010.
9. "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. Jolie, Angelina (14 May 2013). "Opinion | My Medical Choice". The New York Times. 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. Health Quality Ontario (2017). "Pharmacogenomic Testing for Psychotropic Medication Selection: A Systematic Review of the Assurex GeneSight Psychotropic Test". Ontario Health Technology Assessment Series. 17 (4): 1–39. ISSN 1915-7398. PMC 5433545. 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. Ghosh, Shubha "Identity, Invention, and the Culture of Personalized Medicine Patenting", Cambridge University Press, September 10, 2012, Pages 41 and 42, ISBN 978-1107011915
21. "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. Cook-Deegan, Robert; Derienzo, Christopher; Carbone, Julia; Chandrasekharan, Subhashini; Heaney, Christopher; Conover, Christopher (1 March 2010). "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.
25. Easton DF, Bishop DT, Ford D, Crockford GP (24 January 2014). "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.
26. Miki, Y.; Swensen, J.; Shattuck-Eidens, D.; Futreal, P.; Harshman, K.; Tavtigian, S.; Liu, Q.; Cochran, C.; Bennett, L.; Ding, W.; Et, al. (7 October 1994). "A strong candidate for the breast and ovarian cancer susceptibility gene BRCA1". Science. 266 (5182): 66–71. Bibcode:1994Sci...266...66M. doi:10.1126/science.7545954. 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

• Myriad Genetics home page
• Court documents for ACLU suit