Myriad Genetics
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Myriad Genetics, Inc. is an American genetic testing and
precision medicine Precision, precise or precisely may refer to: Science, and technology, and mathematics Mathematics and computing (general) * Accuracy and precision, measurement deviation from true value and its scatter * Significant figures, the number of digit ...
company based in
Salt Lake City, Utah Salt Lake City (often shortened to Salt Lake and abbreviated as SLC) is the Capital (political), capital and List of cities and towns in Utah, most populous city of Utah, United States. It is the county seat, seat of Salt Lake County, Utah, Sal ...
, 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
gene In biology, the word gene (from , ; "...Wilhelm Johannsen coined the word gene to describe the Mendelian units of heredity..." meaning ''generation'' or ''birth'' or ''gender'') can have several different meanings. The Mendelian gene is a ba ...
s 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 Precision, precise or precisely may refer to: Science, and technology, and mathematics Mathematics and computing (general) * Accuracy and precision, measurement deviation from true value and its scatter * Significant figures, the number of digit ...
), and measure disease activity.


History

The global search for the genetic basis of breast cancer began in April 1978 when Dr.
Mark Skolnick Mark Henry Skolnick (born January 28, 1946) is an American geneticist and the founder of Myriad Genetics, Myriad Genetics Inc, an American molecular diagnostic company based in Salt Lake City, Utah. His highest cited paper is "Construction of a gen ...
began his research on family disease and linkages at the University of Utah. Numerous other groups also worked to locate BRCA, including
Mary-Claire King Mary-Claire King (born February 27, 1946) 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 g ...
, Ph.D., from the
University of California, Berkeley The University of California, Berkeley (UC Berkeley, Berkeley, Cal, or California) is a public land-grant research university in Berkeley, California. Established in 1868 as the University of California, it is the state's first land-grant u ...
where she announced the localization through
linkage analysis Genetic linkage is the tendency of DNA sequences that are close together on a chromosome to be inherited together during the meiosis phase of sexual reproduction. Two genetic markers that are physically near to each other are unlikely to be separ ...
of a gene associated with increased risk for breast cancer (
BRCA1 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 h ...
) to the long arm of chromosome 17. To locate the actual gene, Dr. Skolnick and his colleagues invented a landmark gene mapping technique known as Restriction Fragment-length Polymorphisms (RFLP). Gilbert joined Kimberlin in 1991, and they teamed up with Skolnick to form Myriad Genetics. In August 1994, Mark Skolnick and researchers at Myriad, along with colleagues at the
University of Utah The University of Utah (U of U, UofU, or simply The U) is a public research university in Salt Lake City, Utah. It is the flagship institution of the Utah System of Higher Education. The university was established in 1850 as the University of De ...
, the U.S. National Institutes of Health (NIH), and McGill University patented and sequenced BRCA1. The firm then established the first clinical laboratory to commercialize genomic testing. Its capabilities have saved countless lives by informing millions of women about their BRCA1/2 risk. Myriad created the first test to measure the molecular biology and aggressiveness of men’s prostate cancer, 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, commercialized a psychotropic test that covers 61 medications commonly prescribed for depression, anxiety,
ADHD Attention deficit hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterised by excessive amounts of inattention, hyperactivity, and impulsivity that are pervasive, impairing in multiple contexts, and otherwise age-inapp ...
. Also pioneering the field of DNA-specific medicine, Myriad received the first
FDA The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food s ...
approval for a lab-developed diagnostic test for use in predicting the responses to a DNA-repair drug.


Acquisitions and Subsidiaries

In August 2016, Myriad announced it would acquire Assurex Health for up to $410million, expanding the company's genetic testing for psychotropic medicine selection. In July 2018, Myriad completed an acquisition of reproductive genetic testing firm Counsyl for $375million, expanding the company's testing capabilities to carrier and prenatal screening. Other subsidiaries of Myriad Genetics include Myriad International and Myriad Autoimmune (aka Crescendo Bioscience).


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 Kevin Kimberlin is chairman of Spencer Trask & Co., an advanced technology firm. Kimberlin has distinguished himself by partnering with or backing "obsessive missionaries" including Jonas Salk, Walter Gilbert, John Wennberg and Robert Langer. T ...
(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 The University of Utah (U of U, UofU, or simply The U) is a public research university in Salt Lake City, Utah. It is the flagship institution of the Utah System of Higher Education. The university was established in 1850 as the University of De ...
).


Products

Among the prognostic tests developed and marketed by Myriad is "Prolaris", which uses
gene expression profiling In the field of molecular biology, gene expression profiling is the measurement of the activity (the expression) of thousands of genes at once, to create a global picture of cellular function. These profiles can, for example, distinguish between c ...
to provide a 10-year
prostate cancer Prostate cancer is cancer of the prostate. Prostate cancer is the second most common cancerous tumor worldwide and is the fifth leading cause of cancer-related mortality among men. The prostate is a gland in the male reproductive system that sur ...
-specific risk of death. Another prognostic test, marketed as "myRisk Hereditary Cancer", reviews
genetic marker A genetic marker is a gene or DNA sequence with a known location on a chromosome that can be used to identify individuals or species. It can be described as a variation (which may arise due to mutation or alteration in the genomic loci) that can be ...
s correlated with elevated risk of developing any of eight
hereditary cancers A cancer syndrome, or family cancer syndrome, is a genetic disorder in which inherited genetic mutations in one or more genes predispose the affected individuals to the development of cancers and may also cause the early onset of these cancers. Ca ...
.


Controversies

Myriad Genetics's patents on human genes became quite controversial. Following the discovery by
Mary-Claire King Mary-Claire King (born February 27, 1946) 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 g ...
that a gene on chromosome 17 is associated with an increased risk of breast cancer, Myriad attempted to patent this gene. These patents were the subject of scrutiny after Myriad became involved in a lawsuit over its patenting practices, which led to the landmark
Supreme Court A supreme court is the highest court within the hierarchy of courts in most legal jurisdictions. Other descriptions for such courts include court of last resort, apex court, and high (or final) court of appeal. Broadly speaking, the decisions of ...
decision ''
Association for Molecular Pathology v. Myriad Genetics, Inc. ''Association for Molecular Pathology v. Myriad Genetics, Inc.'', 569 U.S. 576 (2013), was a Supreme Court case that challenged the validity of gene patents in the United States, specifically questioning certain claims in issued patents owned or ...
'' 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. Additionally, the discovery of their relevance to breast cancer was funded by the public.


USA: ''Association for Molecular Pathology v. Myriad Genetics'' (2013)

Myriad Genetics was a defendant in the case ''
Association for Molecular Pathology v. Myriad Genetics ''Association for Molecular Pathology v. Myriad Genetics, Inc.'', 569 U.S. 576 (2013), was a Supreme Court case that challenged the validity of gene patents in the United States, specifically questioning certain claims in issued patents owned or ...
'' (formerly ''Association For Molecular Pathology et al. v. United States Patent and Trademark Office''). Lawyers at the
ACLU The American Civil Liberties Union (ACLU) is a nonprofit organization founded in 1920 "to defend and preserve the individual rights and liberties guaranteed to every person in this country by the Constitution and laws of the United States". T ...
served as counsel for the plaintiffs. In the suit, medical associations, doctors, and patients sued Myriad Genetics to challenge seven United States
patents A patent is a type of intellectual property that gives its owner the legal right to exclude others from making, using, or selling an invention for a limited period of time in exchange for publishing an enabling disclosure of the invention."A p ...
on
genes In biology, the word gene (from , ; "...Wilhelm Johannsen coined the word gene to describe the Mendelian units of heredity..." meaning ''generation'' or ''birth'' or ''gender'') can have several different meanings. The Mendelian gene is a ba ...
related to
breast cancer Breast cancer is cancer that develops from breast tissue. Signs of breast cancer may include a lump in the breast, a change in breast shape, dimpling of the skin, milk rejection, fluid coming from the nipple, a newly inverted nipple, or a re ...
and
ovarian cancer Ovarian cancer is a cancerous tumor of an ovary. It may originate from the ovary itself or more commonly from communicating nearby structures such as fallopian tubes or the inner lining of the abdomen. The ovary is made up of three different c ...
. Two of the company's patents on the
BRCA1 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 h ...
and
BRCA2 ''BRCA2'' and BRCA2 () are a human gene and its protein product, respectively. The official symbol (BRCA2, italic for the gene, nonitalic for the protein) and the official name (originally breast cancer 2; currently BRCA2, DNA repair associated) ...
genes were ruled invalid on March 29, 2010, by Judge
Robert W. Sweet Robert Workman Sweet (October 15, 1922 – March 24, 2019) was an American jurist and United States federal judge, United States district judge of the United States District Court for the Southern District of New York. Education and career Sweet ...
in the
U.S. District Court for the Southern District of New York The United States District Court for the Southern District of New York (in case citations, S.D.N.Y.) is a federal trial court whose geographic jurisdiction encompasses eight counties of New York State. Two of these are in New York City: New Y ...
. On appeal, the
Court of Appeals for the Federal Circuit The United States Court of Appeals for the Federal Circuit (in case citations, Fed. Cir. or C.A.F.C.) is a United States court of appeals that has special appellate jurisdiction over certain types of specialized cases in the U.S. federal court ...
reversed the trial court in an opinion dated July 29, 2011 and held that the genes were eligible for patents. On December 7, 2011, the ACLU filed a petition for a
writ of certiorari In law, ''certiorari'' is a court process to seek judicial review of a decision of a lower court or government agency. ''Certiorari'' comes from the name of an English prerogative writ, issued by a superior court to direct that the record of ...
to the
Supreme Court A supreme court is the highest court within the hierarchy of courts in most legal jurisdictions. Other descriptions for such courts include court of last resort, apex court, and high (or final) court of appeal. Broadly speaking, the decisions of ...
. 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. ''Mayo v. Prometheus'', 566 U.S. 66 (2012), was a case decided by the Supreme Court of the United States that unanimously held that claims directed to a method of giving a drug to a patient, measuring metabolites of that drug, and with a known t ...
'', in which the Supreme Court had ruled, just six days earlier, that more restrictive rules were required to patent observations about natural phenomena. 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. On November 30, 2012, the Supreme Court agreed to hear a second challenge to the two gene patents held by Myriad. Oral argument took place on April 15, 2013. On June 13, 2013, in
Association for Molecular Pathology v. Myriad Genetics ''Association for Molecular Pathology v. Myriad Genetics, Inc.'', 569 U.S. 576 (2013), was a Supreme Court case that challenged the validity of gene patents in the United States, specifically questioning certain claims in issued patents owned or ...
(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 naturesuch as a strand of synthetically-produced complementary DNA (cDNA)could still be eligible for patent protection. Myriad Genetics has also been involved in litigation in Australia over the patentability of
DNA sequences A nucleic acid sequence is a succession of bases signified by a series of a set of five different letters that indicate the order of nucleotides forming alleles within a DNA (using GACT) or RNA (GACU) molecule. By convention, sequences are usua ...
(D'Arcy v Myriad Genetics Inc (2015)). Regarding
BRCA1 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 h ...
, 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''.


See also

*
Biological patents in the United States 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 ...


References


External links


Myriad Genetics home page

Court documents for ACLU suit
{{Authority control 1991 establishments in Utah American companies established in 1991 Biotechnology companies established in 1991 Pharmaceutical companies established in 1991 Biotechnology companies of the United States Companies based in Salt Lake City Health care companies based in Utah Medical genetics Pharmaceutical companies of the United States Companies listed on the Nasdaq Genomics companies