Myriad Genetics

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 (prognostic medicine).

History
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. 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.

Founders
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

Subsidiary
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: BRACAnalysis (assesses risk for hereditary breast and ovarian cancer), COLARIS (assesses risk for hereditary colorectal and uterine cancer), COLARIS AP (assesses risk for 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: TheraGuide (predicts toxicity to 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).

Timeline

 * 1991 - BRCA1 was linked to chromosome 17 by UC Berkeley scientists
 * 1991 - Myriad Genetics was founded by Dr. Walter Gilbert, Mark Skolnick, Kevin Kimberlin and Peter Meldrum
 * 1994 - BRCA1 was cloned at the University of Utah in Mark Skolnick’s lab and published by 40 collaborators
 * 1994 - First BRCA1 U.S. patent was filed by the University of Utah, National Institute of Environmental Health Sciences (NIEHS) and Myriad Genetics
 * 1994/1995 - Development of process and laboratory to perform high throughput sequencing by Myriad
 * 1995 - BRCA2 was cloned at Myriad and the University of Utah by Mark Skolnick and collaborators
 * 1995 - First BRCA2 patent filed in the U.S. by the University of Utah and other institutions
 * 1996 - Myriad launched BRACAnalysis, a predictive medicine product for hereditary breast and ovarian cancer
 * 1997 - First BRCA1 patent was granted in the U.S. to the University of Utah, NIEHS and Myriad Genetics
 * 1998 - First BRCA2 patent was granted in the U.S. to the University of Utah, NIEHS and Myriad Genetics
 * 2000 - Myriad launched COLARIS, a predictive medicine product for hereditary colorectal and uterine cancer
 * 2002 - Myriad launched COLARIS AP, a predictive medicine product for adenomatous polyposis colon cancer syndromes
 * 2002 - Myriad launched MELARIS, a predictive medicine product for hereditary melanoma
 * 2007 - Myriad launched TheraGuide 5-FU, a personalized medicine product to predict toxicity to 5-FU-based chemotherapy
 * 2008 - Myriad launched PREZEON, a personalized medicine product 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
 * 2010 - Myriad launched PANEXIA, a predictive medicine product for hereditary pancreatic and related cancers

In July, 2009, the spin off of Myriad Pharmaceuticals, Inc. was completed. Myriad Pharmaceuticals is a biopharmaceutical company focused on the discovery and development of therapeutic products.

BRCA1 Co-discoverers

 * National Institute of Environmental Health Sciences (NIEHS)
 * University of Utah Research Foundation
 * University of Laval/Endo Research – Quebec
 * Hospital for Sick Children – University of Toronto
 * University of Tokyo
 * Myriad Genetics, Inc.

BRCA2 Co-discoverers

 * University of Utah Research Foundation
 * Hospital for Sick Children – University of Toronto
 * University of Pennsylvania
 * Myriad Genetics, Inc.

Legislation and Litigation
Myriad Genetics is a defendant in the case Association For Molecular Pathology et al v. United States Patent and Trademark Office et al. Lawyers at the ACLU serve as counsel for the plaintiffs. In the suit, medical associations, doctors, and patients are suing Myriad Genetics for its United States patents on genes related to breast cancer and ovarian cancer. The defendants' motions to dismiss were denied on November 1, 2009.

Parts 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. Myriad filed a notice of appeal on June 16, 2010 in the United States Court of Appeals for the Federal Circuit. . A New York appeals court decided on 29 July 2011 that the genes were eligible for patents.