Myriad Genetics, Inc. is a molecular diagnostic company based in Salt Lake City, Utah. 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 and tailor a patient's drug dose to ensure optimal treatment (personalized medicine), and assess a patient's risk of disease progression and disease recurrence (personalized medicine). Myriad was the subject of scrutiny after it became involved in a lengthy lawsuit over its controversial patenting practices.[1][2][3]
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 at 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.[4] 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.[5]
The founders of Myriad are Mark Skolnick (Adjunct Professor in the Department of Medical Informatics at the University of Utah), Walter Gilbert (1980 Nobel Laureate in chemistry and Professor in the Department of Molecular and Cellular Biology at Harvard University) and Peter Meldrum (past President and CEO of Agridyne and current CEO and President of Myriad Genetics, Inc) and Kevin Kimberlin of Spencer Trask & Company[6]
Myriad Genetic Laboratories, Inc., a wholly owned subsidiary of Myriad Genetics, Inc., has launched eight commercial molecular diagnostic products, including four predictive medicine, three personalized medicine products and one prognostic medicine product.
Myriad currently offers the following predictive medicine products based on DNA testing from blood: BRACAnalysis (assesses risk for hereditary breast and ovarian cancer), COLARIS (assesses risk for hereditary colorectal and uterine cancer), COLARIS AP (assesses risk for hereditary familial adenomatous polyposis colon cancer syndromes) and MELARIS (assesses risk for hereditary melanoma) and PANEXIA (assess risk for hereditary pancreatic cancer).
Myriad currently offers the following personalized medicine tests based on the investigation of blood or tissues: TheraGuide (predicts toxicity to Fluorouracil (5-FU)-based chemotherapy), OnDose (measures a patient’s exposure to 5-FU chemotherapy), PREZEON (assesses the status of the PTEN gene) and a prognostic medicine product: PROLARIS (assesses the aggressiveness of prostate cancer).
In July, 2009, the spin off, Myriad Pharmaceuticals, was completed. Myriad Pharmaceuticals is a biopharmaceutical company focused on the discovery and development of therapeutic products.[7]
Myriad Genetics is 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[8]). 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 Statespatents on genes related to breast cancer and ovarian cancer.[9]
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.[1][2][3] This was the first time a U.S. court had declared a gene patent invalid.[1] 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.[10]
On December 7, 2011, the ACLU filed a petition for a writ of certiorari to the Supreme Court.[11] 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.[12]
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.[13] On November 30, 2012, The Supreme Court agreed to hear a second challenge to the two gene patents held by Myriad.[14] Oral argument is scheduled for April 15, 2013, with a decision expected by the end of the Supreme Court's term in June.