{{Short description|American biotechnology company}} {{Use dmy dates|date=April 2022}} {{Infobox company

| | name = Myriad Genetics, Inc. | logo = Myriad_genetics_logo.svg | type = Public | traded_as = {{NASDAQ|MYGN}} | founded = {{start date and age|1991}}, in Salt Lake City, Utah, United States | founder = Mark Skolnick<br />Peter Meldrum<br />Kevin Kimberlin | location = Salt Lake City, Utah | key_people = Sam Raha (president and CEO)<br /> | industry = Healthcare<br />Molecular Diagnostics<br />Biotechnology<br />Precision Medicine

| | num_employees = 2,600<ref>{{Cite web|url=https://www.owler.com/company/myriad|title=Myriad's Competitors, Revenue, Number of Employees, Funding, Acquisitions & News - Owler Company Profile}}</ref> | revenue = {{Increase}} $690.6 million (2021)<ref>{{Cite web|url=https://myriad.com/investors/news-release/news-release-detail/?newsItemId=22856|title=Myriad Genetics Reports Fourth Quarter 2021 Results, Provides Updates on Product Performance and Growth Initiatives |date=24 February 2021}}</ref> | website = {{URL|https://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.<ref name=":1">{{Cite journal | last1 = Hall | first1 = J. | last2 = Lee | first2 = M. | last3 = Newman | first3 = B. | last4 = Morrow | first4 = J. | last5 = Anderson | first5 = L. | last6 = Huey | first6 = B. | last7 = King | first7 = M. | title = Linkage of early-onset familial breast cancer to chromosome 17q21 | journal = Science | volume = 250 | issue = 4988 | pages = 1684–1689 | year = 1990 | pmid = 2270482 | doi=10.1126/science.2270482| bibcode = 1990Sci...250.1684H }}</ref>

To further locate the actual gene, Dr. Skolnick and his colleagues invented a gene mapping technique known as Restriction Fragment-length Polymorphisms (RFLP).<ref name=":2">{{Cite book|last=Cook-Deegan|first=Robert M.|title=The gene wars : science, politics, and the human genome|date=1994|publisher=W.W. Norton & Co|isbn=0-393-03572-7|location=New York|oclc=28021657}}</ref> Gilbert joined Kimberlin in 1991, and they teamed up with Skolnick to form Myriad Genetics.<ref>{{Cite book|last=Davies|first=Kevin|title=Breakthrough : the quest to isolate the gene for hereditary breast cancer|date=1995|publisher=Macmillan|others=Michael White|isbn=0-333-61102-0|location=London|pages=199–200|oclc=36138590}}</ref>

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.<ref>{{Cite journal | doi = 10.1126/science.7545954 | last1 = Miki | first1 = Y. | last2 = Swensen | first2 = J. | last3 = Shattuck-Eidens | first3 = D. | last4 = Futreal | first4 = P. A. | last5 = Harshman | first5 = K. | last6 = Tavtigian | first6 = S. | last7 = Liu | first7 = Q. | last8 = Cochran | first8 = C. | last9 = Bennett | first9 = L. M. | last10 = Ding | first10 = W. | last11 = Et | first11 = A. | title = A strong candidate for the breast and ovarian cancer susceptibility gene BRCA1 | journal = Science | volume = 266 | issue = 5182 | pages = 66–71 | year = 1994 | pmid = 7545954| bibcode = 1994Sci...266...66M | doi-access = free }}</ref> They attempted to patent this gene, which resulted in significant controversy and a landmark Supreme Court Case.<ref name="Begley" /><ref name="Schwartz, John and Pollack, Andrew" /><ref name="patentlyo.com" />

The firm then established the first clinical laboratory to commercialize genomic testing.<ref>{{Cite web|date=2017-02-23|title=Xfin Health Information. Featured Customer: Myriad|url=https://www.xifin.com/resources/success-stories/myriad-genetics|access-date=2021-11-16|website=XIFIN|language=en}}</ref><ref>{{Cite news|last=Jolie|first=Angelina|date=2013-05-14|title=Opinion {{!}} My Medical Choice|language=en-US|work=The New York Times|url=https://www.nytimes.com/2013/05/14/opinion/my-medical-choice.html|access-date=2021-11-16|issn=0362-4331}}</ref> Myriad created the first test to measure the molecular biology and aggressiveness of men’s prostate cancer,<ref>{{Cite web|last=Gross|first=Charles|date=2015-10-07|title=Myriad Genetics, Tufts Health Plan Sign 3-Year Contract to Cover Prolaris for Members With Localized Prostate Cancer|url=https://www.benzinga.com/news/15/10/5893607/myriad-genetics-tufts-health-plan-sign-3-year-contract-to-cover-prolaris-for-memb|access-date=2021-11-16|website=Benzinga|language=English}}</ref> 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,<ref>{{Cite web|title=Myriad Genetics' RiskScore Accurately Identifies Breast Cancer Risk in Undiagnosed Women of All Ancestries|url=https://www.cancernetwork.com/view/myriad-genetics-riskscore-accurately-identifies-breast-cancer-risk-in-undiagnosed-women-of-all-ancestries|access-date=2021-11-16|website=Cancer Network|date=3 August 2021 }}</ref> commercialized a psychotropic test that covers 61 medications commonly prescribed for depression, anxiety, ADHD.<ref>{{Cite journal|last=Health Quality Ontario|date=2017|title=Pharmacogenomic Testing for Psychotropic Medication Selection: A Systematic Review of the Assurex GeneSight Psychotropic Test|journal=Ontario Health Technology Assessment Series|volume=17|issue=4|pages=1–39|issn=1915-7398|pmc=5433545|pmid=28515818}}</ref> 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.<ref>{{Cite web|title=Myriad Receives FDA Approval of BRACAnalysis CDx® as Companion Diagnostic for Lynparza™ (olaparib) In Patients with Metastatic Breast Cancer {{!}} Myriad Genetics, Inc.|url=https://investor.myriad.com/news-releases/news-release-details/myriad-receives-fda-approval-bracanalysis-cdxr-companion|access-date=2021-11-16|website=investor.myriad.com|language=en}}</ref>

=== Acquisitions and subsidiaries === In August 2016, Myriad announced it would acquire Assurex Health for up to $410{{nbsp}}million, expanding the company's genetic testing for psychotropic medicine selection.<ref>{{Cite web | url=http://www.genengnews.com/gen-news-highlights/myriad-to-acquire-assurex-health-for-up-to-410m/81253047/ | title=Myriad to Acquire Assurex Health for up to $410M| date=2016-08-04}}</ref>

In July 2018, Myriad completed an acquisition of reproductive genetic testing firm Counsyl for $375{{nbsp}}million, expanding the company's testing capabilities to carrier and prenatal screening.<ref>{{Cite news|url=https://www.genomeweb.com/molecular-diagnostics/myriad-genetics-completes-acquisition-counsyl#.W8ozxITjNhE|title=Myriad Genetics Completes Acquisition of Counsyl|work=GenomeWeb|access-date=2018-10-19|language=en}}</ref>

Other subsidiaries of Myriad Genetics include Myriad International and Myriad Autoimmune (aka Crescendo Bioscience).<ref>{{Cite web|title=Myriad Genetics and Subsidiary Locations and Directions|url=http://myriad.com/about-myriad/locations-directions/overview/|access-date=2021-11-16|website=Myriad Genetics, Inc.|language=en-US}}</ref>

===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).<ref>"Breakthrough: The Race to Find the Breast Cancer Gene," page 199, by Kevin Davies and Michael White John Wiley & Sons.</ref><ref>Ghosh, Shubha "Identity, Invention, and the Culture of Personalized Medicine Patenting", Cambridge University Press, September 10, 2012, Pages 41 and 42, {{ISBN|978-1107011915}}</ref>

== Products<!-- There was formerly a major section for products, but it was completely unreferenced; only include here referenced material, and be brief while providing context. --> == 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.<ref name=":0">{{Cite news|url=https://www.clinicalomics.com/articles/clinical-urologists-group-supports-genomic-testing-for-prostate-cancer/1521|title=Clinical Urologists Group Supports Genomic Testing for Prostate Cancer|last=<!--no byline-->|date=March 6, 2018|work=ClinicalOMICs|access-date=March 9, 2018}}</ref> Another prognostic test, marketed as "myRisk Hereditary Cancer", reviews genetic markers correlated with elevated risk of developing any of eleven hereditary cancers.<ref name=":0" />

==Controversies==

Myriad Genetics's patents on human genes became quite controversial.<ref>{{cite news|author=Tamar Lewin |url=https://www.nytimes.com/1996/05/21/us/move-to-patent-cancer-gene-is-called-obstacle-to-research.html |title=Move to Patent Cancer Gene Is Called Obstacle to Research |work=The New York Times |date=1996-05-21 |access-date=2014-03-06}}</ref><ref>{{cite news|url=https://www.nytimes.com/2010/11/02/health/02gene.html|title=Gene Patent Ruling Raises Questions for Industry|newspaper=The New York Times|access-date=2014-03-06|first=Andrew|last=Pollack|date=November 1, 2010}}</ref> Following the discovery by Mary-Claire King that a gene on chromosome 17 is associated with an increased risk of breast cancer,<ref name=":1" /> Myriad attempted to patent this gene. These patents were the subject of scrutiny after Myriad became involved in a lawsuit over its patenting practices,<ref name="Begley" /><ref name="Schwartz, John and Pollack, Andrew">{{cite news|author1=Schwartz, John|author2=Pollack, Andrew|date=March 29, 2010|title=Judge Invalidates Human Gene Patent|work=The New York Times|url=https://www.nytimes.com/2010/03/30/business/30gene.html|access-date=March 29, 2010}}</ref><ref name="patentlyo.com">{{cite web|date=2010-03-29|title=ACLU v. Myriad Genetics opinion|url=http://www.patentlyo.com/files/myriad-opinion.pdf|url-status=dead|archive-url=http://webarchive.loc.gov/all/20100407195119/http%3A//www.patentlyo.com/files/myriad%2Dopinionj.pdf|archive-date=2010-04-07|access-date=2010-03-30}}</ref> 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.<ref>{{cite journal |last1=Cook-Deegan |first1=Robert |last2=Derienzo |first2=Christopher |last3=Carbone |first3=Julia |last4=Chandrasekharan |first4=Subhashini |last5=Heaney |first5=Christopher |last6=Conover |first6=Christopher |title=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 |journal=Genetics in Medicine |date=2010-03-01 |volume=12 |issue=4 |pages=S15–18, S20–24, S27–28 |doi=10.1097/GIM.0b013e3181d5a67b |pmid=20393305 |pmc=3047448 }}</ref> Additionally, the discovery of their relevance to breast cancer<ref>{{cite journal|title=Genetic linkage analysis in familial breast and ovarian cancer: results from 214 families. The Breast Cancer Linkage Consortium |date=2014-01-24 |pmc=1682082 |pmid=8460634 |volume=52 |issue=4 |journal=Am. J. Hum. Genet. |pages=678–701 |vauthors=Easton DF, Bishop DT, Ford D, Crockford GP}}</ref><ref>{{cite journal|title=A strong candidate for the breast and ovarian cancer susceptibility gene BRCA1 |journal=Science |volume=266 |issue=5182 |pages=66–71 |date=1994-10-07 |doi=10.1126/science.7545954 |pmid = 7545954|last1=Miki |first1=Y. |last2=Swensen |first2=J. |last3=Shattuck-Eidens |first3=D. |last4=Futreal |first4=P. |last5=Harshman |first5=K. |last6=Tavtigian |first6=S. |last7=Liu |first7=Q. |last8=Cochran |first8=C. |last9=Bennett |first9=L. |last10=Ding |first10=W. |last11=Et |first11=al. |bibcode=1994Sci...266...66M |doi-access=free }}</ref> 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''<ref>{{cite web|publisher=Justia.com|url=http://news.justia.com/cases/featured/new-york/nysdce/1:2009cv04515/345544/|title=Association For Molecular Pathology et al v. United States Patent and Trademark Office et al|date=May 12, 2009}}</ref>). 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.<ref>{{cite web|publisher=American Civil Liberties Union|url=https://www.aclu.org/freespeech/gen/brca.html|title=ACLU Challenges Patents on Breast Cancer Genes|date=June 6, 2008}}</ref>

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 US<sup>[https://www.komen.org/breast-cancer/risk-factor/gene-mutations-genetic-testing/?gad_source=1&gclid=EAIaIQobChMIxNfK6-XeggMVLElHAR3SXADwEAAYAiAAEgLq3PD_BwE <nowiki>[27]</nowiki>]</sup>, 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.<ref name=Begley>{{cite news | author=Begley, Sharon | title=In Surprise Ruling, Court Declares Two Gene Patents Invalid | url=http://blog.newsweek.com/blogs/thehumancondition/archive/2010/03/29/in-surprise-ruling-court-declares-two-gene-patents-invalid.aspx | date=March 29, 2010 | publisher=Newsweek | access-date=March 29, 2010 | url-status=dead | archive-url=https://web.archive.org/web/20100419115742/http://blog.newsweek.com/blogs/thehumancondition/archive/2010/03/29/in-surprise-ruling-court-declares-two-gene-patents-invalid.aspx | archive-date=April 19, 2010 }}</ref><ref name="Schwartz, John and Pollack, Andrew"/><ref name="patentlyo.com"/> 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.<ref>{{cite web | url=http://investor.myriad.com/releasedetail.cfm?ReleaseID=595288 |publisher=Myriad Genetics | title=Myriad Applauds the Court of Appeals' Decision to Uphold Gene Patenting|access-date=2011-11-20 |date=2011-07-29 }}</ref> On December 7, 2011, the ACLU filed a petition for a writ of certiorari to the Supreme Court.<ref>{{cite web|url=http://jurist.org/paperchase/2011/12/aclu-ask-supreme-court-to-rule-on-gene-patent-case.php |title=Paper Chase: ACLU asks Supreme Court to rule on gene patent case |publisher=JURIST |date=2011-12-08 |access-date=2014-03-06}}</ref> 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.<ref>{{cite news| url=https://www.nytimes.com/2012/03/27/business/high-court-orders-new-look-at-gene-patents.html | work=The New York Times | first=Andrew | last=Pollack | title=Supreme Court Orders New Look at Gene Patents | date=March 26, 2012}}</ref>

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".<ref>{{cite news|date=August 16, 2012|url=https://www.nytimes.com/2012/08/17/business/court-reaffirms-right-of-myriad-genetics-to-patent-genes.html|title=Court Reaffirms Right of Myriad Genetics to Patent Genes|work=The New York Times}}</ref> On November 30, 2012, the Supreme Court agreed to hear a second challenge to the two gene patents held by Myriad.<ref>{{cite news|date=December 3, 2012|url=http://www.businessweek.com/ap/2012-12-03/myriad-genetics-slips-on-supreme-court-review|archive-url=https://web.archive.org/web/20121207104109/http://www.businessweek.com/ap/2012-12-03/myriad-genetics-slips-on-supreme-court-review|url-status=dead|archive-date=7 December 2012|title=Myriad Genetics slips on Supreme Court review|publisher=Bloomberg Business Week}}</ref> Oral argument took place on April 15, 2013.<ref>{{cite web|title=Association for Molecular Pathology v. Myriad Genetics|url=https://www.aclu.org/free-speech-technology-and-liberty-womens-rights/association-molecular-pathology-v-myriad-genetics|publisher=ACLU|access-date=May 17, 2013|quote=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.}}</ref> 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{{mdash}}such as a strand of synthetically-produced complementary DNA (cDNA){{mdash}}could still be eligible for patent protection.<ref>{{cite news|last=Liptak|first=Adam|title=Supreme Court Rules Human Genes May Not Be Patented|url=https://www.nytimes.com/2013/06/14/us/supreme-court-rules-human-genes-may-not-be-patented.html|access-date=June 13, 2013|newspaper=The New York Times|date=June 13, 2013}}</ref><ref>{{cite news|last1=Kendall|first1=Brent|last2=Bravin|first2=Jess|title=Supreme Court Says Human Genes Aren't Patentable|url=https://www.wsj.com/articles/SB10001424127887324049504578543250466974398|access-date=June 13, 2013|newspaper=Wall Street Journal|date=June 13, 2013}}</ref>

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''.<ref>''D'Arcy v Myriad Genetics Inc'' [2015] HCA 35.</ref><ref>{{cite news|last=Harrison|first=Dan|title=Genetic patents: Grandmother Yvonne D'Arcy takes on global giant Myriad Genetics|url=http://www.smh.com.au/federal-politics/political-news/genetic-patents-grandmother-yvonne-darcy-takes-on-global-giant-myriad-genetics-20150616-ghphvj.html|newspaper=Sydney Morning Herald|date=June 16, 2015|access-date=October 14, 2015}}</ref><ref>{{cite news|last=Corderoy|first=Amy|title=Landmark High Court ruling on BRCA1 gene patent as pensioner wins legal case|url=http://www.smh.com.au/national/health/landmark-high-court-ruling-on-brca1-gene-patent-as-pensioner-wins-legal-case-20151006-gk2wvu.html|newspaper=Sydney Morning Herald|date=October 7, 2015|access-date=October 14, 2015}}</ref>

==See also== * Biological patents in the United States

==References== {{Reflist|30em}}

==External links == * [http://www.myriad.com/ Myriad Genetics home page] * [http://dockets.justia.com/docket/court-nysdce/case_no-1:2009cv04515/case_id-345544/ Court documents for ACLU suit]

{{Pharmaceutical companies of the United States}} {{Authority control}}

Category:1991 establishments in Utah Category:American companies established in 1991 Category:Biotechnology companies established in 1991 Category:Pharmaceutical companies established in 1991 Category:Biotechnology companies of the United States Category:Companies based in Salt Lake City Category:Health care companies based in Utah Category:Medical genetics Category:Pharmaceutical companies of the United States Category:Companies listed on the Nasdaq Category:Genomics companies