Myriad Genetics, Inc. is an American

genetic testing Genetic testing, also known as DNA testing, is used to identify changes in DNA sequence or chromosome structure. Genetic testing can also include measuring the results of genetic changes, such as RNA analysis as an output of gene expression, or ...

and

precision medicine Precision, precise or precisely may refer to: Arts and media * ''Precision'' (march), the official marching music of the Royal Military College of Canada * "Precision" (song), by Big Sean * ''Precisely'' (sketch), a dramatic sketch by the Eng ...

company based in

Salt Lake City, Utah Salt Lake City, often shortened to Salt Lake or SLC, is the List of capitals in the United States, capital and List of cities and towns in Utah, most populous city of the U.S. state of Utah. It is the county seat of Salt Lake County, Utah, Salt ...

, 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 has two meanings. The Mendelian gene is a basic unit of heredity. The molecular gene is a sequence of nucleotides in DNA that is transcribed to produce a functional RNA. There are two types of molecular genes: protei ...

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 (

), and measure disease activity.

History

The global search for the genetic basis of breast cancer began when

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 university, public Land-grant university, land-grant research university in Berkeley, California, United States. Founded in 1868 and named after t ...

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 ...

) to the long arm of chromosome 17. To further locate the actual gene, Dr. Skolnick and his colleagues invented a 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 (the U, U of U, or simply Utah) is a public university, public research university in Salt Lake City, Utah, United States. It was established in 1850 as the University of Deseret (Book of Mormon), Deseret by the General A ...

, the U.S. National Institutes of Health (NIH), and McGill University sequenced BRCA1. They attempted to patent this gene, which resulted in significant controversy and a landmark Supreme Court Case. The firm then established the first clinical laboratory to commercialize genomic testing. 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 symptoms of inattention, hyperactivity, impulsivity, and emotional dysregulation that are excessive and pervasive, impairing in multiple ...

. 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 ...

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.) and Mark Skolnick (Adjunct Professor in the Department of Medical Informatics at the

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 gene expression, expression) of thousands of genes at once, to create a global picture of cellular function. These profiles can, for example, dis ...

to provide a 10-year

prostate cancer Prostate cancer is the neoplasm, uncontrolled growth of cells in the prostate, a gland in the male reproductive system below the bladder. Abnormal growth of the prostate tissue is usually detected through Screening (medicine), screening tests, ...

-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 ...

s correlated with elevated risk of developing any of eleven

hereditary cancers A hereditary cancer syndrome (familial/family cancer syndrome, inherited cancer syndrome, cancer predisposition syndrome, cancer syndrome, etc.) is a genetic disorder in which inherited genetic mutations in one or more genes predispose the affect ...

Controversies

Myriad Genetics's patents on human genes became quite controversial. Following the discovery by

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 In most legal jurisdictions, a supreme court, also known as a court of last resort, apex court, high (or final) court of appeal, and court of final appeal, is the highest court within the hierarchy of courts. Broadly speaking, the decisions of ...

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. Additionally, the discovery of their relevance to breast cancer 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 ''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 isola ...

'' (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 an American nonprofit civil rights organization founded in 1920. ACLU affiliates are active in all 50 states, Washington, D.C., and Puerto Rico. The budget of the ACLU in 2024 was $383 million. ...

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 sufficiency of disclosure, enabling discl ...

genes In biology, the word gene has two meanings. The Mendelian gene is a basic unit of heredity. The molecular gene is a sequence of nucleotides in DNA that is transcribed to produce a functional RNA. There are two types of molecular genes: protei ...

related to

breast cancer Breast cancer is a cancer that develops from breast tissue. Signs of breast cancer may include a Breast lump, lump in the breast, a change in breast shape, dimpling of the skin, Milk-rejection sign, milk rejection, fluid coming from the nipp ...

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 ...

. Two of the company's patents on the

and

BRCA2 ''BRCA2'' and BRCA2 () are human genes and their protein products, 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 associate ...

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

7">[27
/nowiki>/sup>, were ruled invalid on March 29, 2010, by Judge Robert W. Sweet">7<_a><br>_nowiki>.html" ;"title="7">[27
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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 the State of New York. Two of these are in New York City ...

. On appeal, the United States Court of Appeals for the Federal Circuit">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 one of the 13 United States courts of appeals. It has special appellate jurisdiction over certain categories of cases in the U.S. federal ...

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 a prerogative writ in England, issued by a superior court to direct that the record of ...

to the

. 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. 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 In a patent or patent application, the claims define in technical terms the extent, i.e. the scope, of the protection conferred by a patent, or the protection sought in a patent application. The claims particularly point out the subject matter whi ...

on methods comprising comparison of DNA sequences, as unpatentable "mental acts". 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

(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 within the nucleotides forming alleles within a DNA (using GACT) or RNA (GACU) molecule. This succession is denoted by a series of a set of five different letters that indicate the order of the ...

(D'Arcy v Myriad Genetics Inc (2015)). Regarding

, 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''.

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