Myriad Genetics

From Wikipedia, the free encyclopedia
Jump to: navigation, search
Myriad Genetics
Public
Traded as NASDAQMYGN
Industry Healthcare
Molecular Diagnostics
Biotechnology
Personalized Medicine
Founded Salt Lake City, Utah, United States (1992)
Headquarters Salt Lake City, Utah
Key people
Mark Capone, President and CEO
Mark Skolnick, Co-Founder
Pete Meldrum, Co-Founder
Jerry Lanchbury, CSO
Walter Gilbert, Director and Vice Chair
Website www.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 (personalized medicine), assess a patient's risk of disease progression and disease recurrence (personalized medicine), and measure disease activity. The discovery of the breast cancer gene, BRCA1 was universally acclaimed as a monumental achievement: “There is no more exciting story in medical science.”[1] Myriad was the subject of scrutiny after it became involved in a lawsuit over its patenting practices,[2][3][4] which led to the landmark Supreme Court decision Association for Molecular Pathology v. Myriad Genetics.

In August 2016 the company announced it would acquire Assurex Health for up to $410 million, expanding the companys genetic testing for psychotropic medicine selection.[5]

History[edit]

The global search for a genetic basis for breast and ovarian cancer began in earnest in 1988. In 1990, at an American Society of Human Genetics Meeting, a team of scientists led by Mary-Claire King, Ph.D., from 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.[6] 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.[7]

Founders[edit]

The founders of Myriad were 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, Crescendo Bioscience, Sividon Diagnostics, and Assurex Health.

Products[edit]

Myriad has launched twelve commercial molecular diagnostic products, including one hereditary cancer risk product, three personalized medicine products, two prognostic products, one diagnostic product and one disease activity product. The Company currently offers Myriad myRisk Hereditary Cancer®, which is a multigene panel test that identifies an elevated risk for eight important cancers including breast, colon, ovarian, endometrial, pancreatic, prostate and gastric cancers and melanoma. Myriad offers the following personalized medicine tests: BRACAnalysis CDx®, the only FDA-approved companion diagnostic for use with AstraZeneca’s Lynparza™; myChoice® HRD, the most comprehensive homologous recombination deficiency test to detect when a tumor has lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors; and EndoPredict, a next-generation, multigene prognostic test for patients diagnosed with breast cancer that provides physicians with information to devise personalized treatment plans. In addition, Myriad has two prognostic medicine products: the Prolaris® test, which assesses the aggressiveness of prostate cancer and Myriad myPlan® Lung Cancer, which measures how fast a lung cancer tumor is growing. Myriad myPath® Melanoma is a clinically validated diagnostic test that is used as an adjunct to histopathology when the distinction between a benign skin lesion and a malignant melanoma cannot be made confidently by histopathology alone. Vectra® DA is an advanced blood test for rheumatoid arthritis (RA) that measures the levels of 12 protein biomarkers known to be important in RA and combines these levels into a single score, which can be used to provide a quantitative measure to objectively assess and track RA disease activity.

Timeline[edit]

  • 1991 - Myriad Genetics was founded by Mark Skolnick, Peter Meldrum and Kevin Kimberlin
  • 1993 - Myriad announced the discovery of the P16 gene that is associated with hereditary melanoma
  • 1994 - BRCA1 was cloned in Mark Skolnick’s lab and published by 40 collaborators
  • 1994/1995 - Development of process and laboratory to perform high throughput sequencing by Myriad
  • 1995 - BRCA2 was sequenced by Mark Skolnick and collaborators
  • 1995 - Myriad became a public company traded on NASDAQ under the ticker MYGN
  • 1996 - Myriad launched BRACAnalysis, the first full-length gene sequencing test for hereditary breast and ovarian cancer
  • 1997 - Myriad announced the discovery of the PTEN gene that is associated with a large number of cancers
  • 1998 - Myriad launched ProNet, a proprietary protein-interaction technology
  • 1999 - Myriad Pharmaceuticals was founded to develop novel drugs
  • 2000 - Myriad launched COLARIS, a genetic test for hereditary colorectal and uterine cancer
  • 2001 - Myriad announced it had sequenced the complete rice genome
  • 2001 - Myriad provided genotyping capabilities to the New York City Coroner’s Office to help identify victims of 9/11
  • 2001 - Myriad launched MELARIS, a genetic test for hereditary melanoma
  • 2002 - Myriad launched COLARIS AP, a genetic test for adenomatous polyposis colon cancer syndromes
  • 2003 - Myriad announced the discovery of major depression gene in collaboration with Abbott Laboratorie
  • 2004 - Myriad Pharmaceuticals submitted investigational new drug applications for two cancer drugs to the FDA
  • 2004 - Myriad had tested more than 100,000 patients with BRACAnalysis
  • 2005 - Myriad announced results of a Phase 2 Alzheimer’s drug clinical trial
  • 2006 - Myriad launched BART, a large rearrangement test for high-risk breast cancer patients
  • 2007 - Myriad launched TheraGuide 5-FU, a personalized medicine product to predict toxicity to 5-FU-based chemotherapy
  • 2008 - Myriad launched BRACAnalysis for the women’s health preventative care market
  • 2008 - Myriad launched PREZEON, a genetic test to assess the status of the PTEN gene
  • 2009 - Myriad launched OnDose, a personalized medicine product to measure a patient’s exposure to 5-FU chemotherapy
  • 2009 - Myriad announced the spinoff to shareholders of its pharmaceutical business
  • 2010 - Myriad launched Prolaris, the first prognostic test to predict prostate cancer survival
  • 2010 - Myriad launched PANEXIA, a predictive medicine product for hereditary pancreatic and related cancers
  • 2011 - Myriad acquired Texas-based Rules Based Medicine and formed Myriad RBM
  • 2012 - Myriad opened its European laboratory in Munich, Germany
  • 2013 - The one-millionth patient was tested with BRACAnalysis
  • 2013 - Myriad launched the myRisk Hereditary Cancer, myPlan Lung Cancer and myPath Melanoma tests
  • 2014 - Myriad acquired Crescendo Bioscience whose main product,Vectra DA, is a blood test to measure disease activity in rheumatoid arthritis[10]
  • 2014 - Myriad submitted a premarket approval application to the FDA for BRACAnalysis CDx as a companion diagnostic
  • 2014 - Myriad licensed EndoPredict, a second-generation breast cancer test from Sividon Diagnostics GmbH[11]
  • 2014 - Myriad received FDA approval for its BRACAnalysis CDx test to identify patients with ovarian cancer who may benefit from AstraZeneca's PARP inhibitor Lynparza (olaparib)
  • 2015 - Myriad unveiled its new logo, the first update since the Company’s founding in 1991
  • 2015 - Myriad received Medicare coverage for Prolaris, a test to assess the aggressiveness of prostate cancer
  • 2015 - Myriad and Tufts Health Plan sign agreement to cover Prolaris for members with localized prostate cancer
  • 2016 - Myriad acquired Sividon Diagnostics, a leading breast cancer prognostic company
  • 2016 - Myriad acquired Assurex Health, a personalized medicine company that specializes in pharmacogenomics

Co-discoverers[edit]

BRCA1[edit]

BRCA2[edit]

Controversies[edit]

Myriad Genetics's intention to patent human genes led to intense controversy.[12][13] First, because genes occur naturally in every human, and in addition to moral questions raised, patenting them would constitute an obstacle to biomedical research worldwide. Secondly, because the discovery of their relevance to breast cancer[14][15] was funded by the public. Third, because the company was selling its breast cancer diagnostic test for a price many described as "outrageous":[16] $4000, the price of a whole genome sequencing[17] (around 20,000 genes analyzed), when the test only looked at two genes.

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[18]). Lawyers at the ACLU serve 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.[19]

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.[2][3][4] 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.[20]

On December 7, 2011, the ACLU filed a petition for a writ of certiorari to the Supreme Court.[21] 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.[22]

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.[23] On November 30, 2012, The Supreme Court agreed to hear a second challenge to the two gene patents held by Myriad.[24] Oral argument took place on April 15, 2013.[25] 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.[26][27]

Australia: D'Arcy v Myriad Genetics Inc (2015)[edit]

Myriad Genetics has also been involved in litigation in Australia over the patentability of DNA sequences. 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.[28][29][30]

In Australia an invention is patentable if, to begin with, it is a "manner of manufacture".[31] The plurality in the High Court formulated the key question as: "Whether the invention as claimed is for a product made, or a process producing an outcome as a result of human action" (para [28]). It held that the product in issue continued to consist basically of genetic information that occurs naturally, had not been altered as a result of human action, therefore had not been "manufactured" and consequently was not patentable. The plurality reflected that a broader conception of patentability could, both by creating virtual monopolies and by blurring the boundaries of what might come to be patented, produce a chilling effect on research and application, contrary to the purposes of patent protection.

The appellant had cited the recent US Supreme Court decision for comparison. The High Court was also aware that its decision could conflict with recent judicial decisions, as well as patents legislation, in other countries, and possibly with Australia's international obligations; however, it considered these to be issues for the legislature, as well as denying that its decision in this case was intended to set a precedent with regard to genetic patenting generally. In addition, the rest of the court did not dissent from Gordon J's concluding observation: "It is important to notice that the claims made in the patents in suit in the United States of America considered in Association for Molecular Pathology v Myriad Genetics Inc 186 L Ed 2d 124 (2013) were claims to the particular genetic sequences and therefore radically different from the disputed claims in this appeal" (note 232).

See also[edit]

References[edit]

  1. ^ Batt, Sharon. Patient No More: The Politics of Breast Cancer. p 176
  2. ^ a b Begley, Sharon (March 29, 2010). "In Surprise Ruling, Court Declares Two Gene Patents Invalid". Newsweek. Retrieved March 29, 2010. 
  3. ^ a b Schwartz, John; Pollack, Andrew (March 29, 2010). "Judge Invalidates Human Gene Patent". The New York Times. Retrieved March 29, 2010. 
  4. ^ a b "ACLU v. Myriad Genetics opinion" (PDF). 2010-03-29. Retrieved 2010-03-30. 
  5. ^ http://www.genengnews.com/gen-news-highlights/myriad-to-acquire-assurex-health-for-up-to-410m/81253047/
  6. ^ 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. 
  7. ^ 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. 
  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, 10 September 2012, Pages 41 and 42, ISBN 978-1107011915
  10. ^ Walker, Joseph (4 February 2014). "Myriad Genetics to Buy Crescendo Bioscience". The Wall Street Journal. Retrieved 21 October 2015. 
  11. ^ "Myriad Genetics and Sividon Diagnostics Announce Exclusive Co-Marketing Agreement for EndoPredict Outside of the United States". Global Newswire. 20 January 2014. Retrieved 21 October 2015. 
  12. ^ Tamar Lewin (1996-05-21). "Move to Patent Cancer Gene Is Called Obstacle to Research". Nytimes.com. Retrieved 2014-03-06. 
  13. ^ Pollack, Andrew (November 1, 2010). "Gene Patent Ruling Raises Questions for Industry". The New York Times. Retrieved 2014-03-06. 
  14. ^ "Genetic linkage analysis in familial breast and ovarian cancer: results from 214 families. The Breast Cancer Linkage Consortium". Ncbi.nlm.nih.gov. 2014-01-24. Retrieved 2014-03-06. 
  15. ^ "A strong candidate for the breast and ovarian cancer susceptibility gene BRCA1". Sciencemag.org. 1994-10-07. Retrieved 2014-03-06. 
  16. ^ Agus, David B. (May 20, 2013). "The Outrageous Cost of a Gene Test". The New York Times. Retrieved 2014-03-06. 
  17. ^ Karabaliev, Ivan. "The - Scientific American,000 Genome Is Almost Here-–Are We Ready? | Guest Blog, Scientific American Blog Network". Blogs.scientificamerican.com. Retrieved 2014-03-06. 
  18. ^ "Association For Molecular Pathology et al v. United States Patent and Trademark Office et al". Justia.com. May 12, 2009. 
  19. ^ "ACLU Challenges Patents on Breast Cancer Genes". American Civil Liberties Union. June 6, 2008. 
  20. ^ "Myriad Applauds the Court of Appeals' Decision to Uphold Gene Patenting". Myriad Genetics. 2011-07-29. Retrieved 2011-11-20. 
  21. ^ "Paper Chase: ACLU asks Supreme Court to rule on gene patent case". JURIST. 2011-12-08. Retrieved 2014-03-06. 
  22. ^ Pollack, Andrew (March 26, 2012). "Supreme Court Orders New Look at Gene Patents". The New York Times. 
  23. ^ "Court Reaffirms Right of Myriad Genetics to Patent Genes". New York Times. August 16, 2012. 
  24. ^ "Myriad Genetics slips on Supreme Court review". Bloomberg Business Week. December 3, 2012. 
  25. ^ "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. 
  26. ^ Liptak, Adam (June 13, 2013). "Supreme Court Rules Human Genes May Not Be Patented". New York Times. Retrieved June 13, 2013. 
  27. ^ Kendall, Brent; Bravin, Jess (June 13, 2013). "Supreme Court Says Human Genes Aren't Patentable". Wall Street Journal. Retrieved June 13, 2013. 
  28. ^ D'Arcy v Myriad Genetics Inc [2015] HCA 35.
  29. ^ Harrison, Dan (16 June 2015). "Genetic patents: Grandmother Yvonne D'Arcy takes on global giant Myriad Genetics". Sydney Morning Herald. Retrieved 14 October 2015. 
  30. ^ 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. 
  31. ^ Patents Act 1990 (Cth) s 18(1)(a) in ComLaw. For the expression "manner of manufacture", the Patents Act refers to s 6 of the Statute of Monopolies 1624 (Eng).

External links[edit]