Myriad Genetics

Last updated

Myriad Genetics, Inc.
Company type Public
Nasdaq:  MYGN
S&P 600 Component
Industry Healthcare
Molecular Diagnostics
Biotechnology
Precision Medicine
Founded Salt 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
Kevin Kimberlin, Co-Founder
Jerry Lanchbury, CSO
Walter Gilbert, Director and Vice Chair
RevenueIncrease2.svg $690.6 Million(2021) [1]
Number of employees
2,600 [2]
Website www.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.

Contents

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.), 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). [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

Related Research Articles

<span class="mw-page-title-main">Penetrance</span> Proportion of individuals that express the trait associated with a gene variant

Penetrance in genetics is the proportion of individuals carrying a particular variant of a gene (genotype) that also expresses an associated trait (phenotype). In medical genetics, the penetrance of a disease-causing mutation is the proportion of individuals with the mutation that exhibit clinical symptoms among all individuals with such mutation. For example: If a mutation in the gene responsible for a particular autosomal dominant disorder has 75% penetrance, then 75% of those with the mutation will go on to develop the disease, showing its phenotype, whereas 25% will not. 

<span class="mw-page-title-main">BRCA1</span> Gene known for its role in breast cancer

Breast cancer type 1 susceptibility protein is a protein that in humans is encoded by the BRCA1 gene. Orthologs are common in other vertebrate species, whereas invertebrate genomes may encode a more distantly related gene. BRCA1 is a human tumor suppressor gene and is responsible for repairing DNA.

As with all utility patents in the United States, a biological patent provides the patent holder with the right to exclude others from making, using, selling, or importing the claimed invention or discovery in biology for a limited period of time - for patents filed after 1998, 20 years from the filing date.

<span class="mw-page-title-main">BRCA2</span> Gene known for its role in breast cancer

BRCA2 and BRCA2 are human genes and their protein products, respectively. The official symbol and the official name are maintained by the HUGO Gene Nomenclature Committee. One alternative symbol, FANCD1, recognizes its association with the FANC protein complex. Orthologs, styled Brca2 and Brca2, are common in other vertebrate species. BRCA2 is a human tumor suppressor gene, found in all humans; its protein, also called by the synonym breast cancer type 2 susceptibility protein, is responsible for repairing DNA.

<span class="mw-page-title-main">Mary-Claire King</span> American geneticist

Mary-Claire King is an American geneticist. She was the first to show that breast cancer can be inherited due to mutations in the gene she called BRCA1. She studies human genetics and is particularly interested in genetic heterogeneity and complex traits. She studies the interaction of genetics and environmental influences and their effects on human conditions such as breast and ovarian cancer, inherited deafness, schizophrenia, HIV, systemic lupus erythematosus and rheumatoid arthritis. She has been the American Cancer Society Professor of the Department of Genome Sciences and of Medical Genetics in the Department of Medicine at the University of Washington since 1995.

Predictive medicine is a field of medicine that entails predicting the probability of disease and instituting preventive measures in order to either prevent the disease altogether or significantly decrease its impact upon the patient.

<span class="mw-page-title-main">BRIP1</span> Mammalian protein found in Homo sapiens

Fanconi anemia group J protein is a protein that in humans is encoded by the BRCA1-interacting protein 1 (BRIP1) gene.

<span class="mw-page-title-main">PALB2</span> Protein-coding gene in the species Homo sapiens

Partner and localizer of BRCA2, also known as PALB2 or FANCN, is a protein which in humans is encoded by the PALB2 gene.

<span class="mw-page-title-main">Tania Simoncelli</span>

Tania Simoncelli is Senior Advisor to the Director of the Broad Institute of MIT and Harvard. Prior to that position, she worked for two years as Assistant Director for Forensic Science and Biomedical Innovation within the Office of Science and Technology Policy. From 2010 to 2013, she worked in the Food and Drug Administration's Office of the Commissioner. From 2003 to 2010, Simoncelli worked as the Science Advisor to the American Civil Liberties Union (ACLU), where she advised the organization on emerging developments in science and technology that pose challenges for civil liberties.

<i>BRCA</i> mutation Medical condition

A BRCA mutation is a mutation in either of the BRCA1 and BRCA2 genes, which are tumour suppressor genes. Hundreds of different types of mutations in these genes have been identified, some of which have been determined to be harmful, while others have no proven impact. Harmful mutations in these genes may produce a hereditary breast–ovarian cancer syndrome in affected persons. Only 5–10% of breast cancer cases in women are attributed to BRCA1 and BRCA2 mutations, but the impact on women with the gene mutation is more profound. Women with harmful mutations in either BRCA1 or BRCA2 have a risk of breast cancer that is about five times the normal risk, and a risk of ovarian cancer that is about ten to thirty times normal. The risk of breast and ovarian cancer is higher for women with a high-risk BRCA1 mutation than with a BRCA2 mutation. Having a high-risk mutation does not guarantee that the woman will develop any type of cancer, or imply that any cancer that appears was actually caused by the mutation, rather than some other factor.

On 29 March 2010, the US District Court for the Southern District of New York found several of the patent claims on the BRCA1 and BRCA2 breast cancer genes held by Myriad Genetics to be invalid. The patents were initially issued on the basis that the genes were isolated and purified to a non-naturally occurring state, however the court found, amongst other things, that the purification was not markedly different from a product of nature and thus was not patentable. The ruling may have implications for holders of other gene patents and the patentability of other naturally occurring substances. It has the potential to directly affect the operation of the healthcare and medical research industries, particularly with regards to cancer treatment and prevention, and may alter the accessibility of such therapies to patients.

<i>In the Family</i> (2008 film) 2008 American film

In the Family is a 2008 documentary film, produced by Kartemquin Films, about predicting breast and ovarian cancer and the choices women make when they are faced with the dangers of a possible life-threatening disease. The film's director, Joanna Rudnick, tests positive for the familial BRCA mutation that increases her chances of developing breast cancer by 60%. Faced with these odds, Rudnick must examine her choices of possibly taking her chances or possibly having her breasts and ovaries removed.

<span class="mw-page-title-main">Hereditary cancer syndrome</span> Inherited genetic condition that predisposes a person to cancer

A hereditary cancer syndrome is a genetic disorder in which inherited genetic mutations in one or more genes predispose the affected individuals to the development of cancer and may also cause early onset of these cancers. Hereditary cancer syndromes often show not only a high lifetime risk of developing cancer, but also the development of multiple independent primary tumors.

A biological patent is a patent on an invention in the field of biology that by law allows the patent holder to exclude others from making, using, selling, or importing the protected invention for a limited period of time. The scope and reach of biological patents vary among jurisdictions, and may include biological technology and products, genetically modified organisms and genetic material. The applicability of patents to substances and processes wholly or partially natural in origin is a subject of debate.

<span class="mw-page-title-main">Molecular diagnostics</span> Collection of techniques used to analyze biological markers in the genome and proteome

Molecular diagnostics is a collection of techniques used to analyze biological markers in the genome and proteome, and how their cells express their genes as proteins, applying molecular biology to medical testing. In medicine the technique is used to diagnose and monitor disease, detect risk, and decide which therapies will work best for individual patients, and in agricultural biosecurity similarly to monitor crop- and livestock disease, estimate risk, and decide what quarantine measures must be taken.

Mark Henry Skolnick is an American geneticist and the founder of Myriad Genetics Inc, an American molecular diagnostic company based in Salt Lake City, Utah. His highest cited paper is "Construction of a genetic linkage map in man using restriction fragment length polymorphisms" at 9,898 times, according to Google Scholar.

A variant of uncertainsignificance (VUS) is a genetic variant that has been identified through genetic testing but whose significance to the function or health of an organism is not known. Two related terms are "gene of uncertain significance" (GUS), which refers to a gene that has been identified through genome sequencing but whose connection to a human disease has not been established, and "insignificant mutation", referring to a gene variant that has no impact on the health or function of an organism. The term "variant' is favored in clinical practice over "mutation" because it can be used to describe an allele more precisely. When the variant has no impact on health, it is called a "benign variant". When it is associated with a disease, it is called a "pathogenic variant". A "pharmacogenomic variant" has an effect only when an individual takes a particular drug and therefore is neither benign nor pathogenic.

Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), was a Supreme Court case, which decided that "a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.” However, as a "bizarre conciliatory prize" the Court allowed patenting of complementary DNA, which contains exactly the same protein-coding base pair sequence as the natural DNA, albeit with introns removed.

<span class="mw-page-title-main">Jórunn Erla Eyfjörð</span> Icelandic academic

Jórunn Erla Eyfjörð is an Icelandic molecular biologist and professor emerita at the Faculty of Medicine of the University of Iceland. She is known for her research on breast cancer genetics.

<span class="mw-page-title-main">Breast and ovarian cancer</span>

Breast and ovarian cancer does not necessarily imply that both cancers occur at the same time, but rather that getting one cancer would lead to the development of the other within a few years. Women with a history of breast cancer have a higher chance of developing ovarian cancer, vice versa.

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. 1 2 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. 1 2 3 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. 1 2 3 Schwartz, John; Pollack, Andrew (29 March 2010). "Judge Invalidates Human Gene Patent". The New York Times . Retrieved 29 March 2010.
  9. 1 2 3 "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. 1 2 "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.
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