ds to continue to launch new potentially transformative products across a set of disease indications, complementing its current businesses in oncology, women’s health, urology, dermatology, and rheumatology. The company’s business strategy is to understand the genetics of human disease to develop and administer the next generation of molecular diagnostic tests. Its business strategy includes various major elements, such as discovering important DNA, RNA, and protein biomarkers, as well as developing novel molecular diagnostic tests; acquiring companies, products, or promising biomarkers from other organizations; independently commercializing new transformative molecular diagnostic tests; diversifying its molecular diagnostic business across multiple disease indications; and expanding its molecular diagnostic business internationally. Research and Development For the year ended June 30, 2014, the company had research and development expense of $67.5 million. Patents and Proprietary Rights The company owns or has license rights to 252 issued patents, as well as various patent applications in the United States and foreign countries. BRACAnalysis: The company owns or has license rights to approximately 500 claims in 25 issued U.S. patents relating to BRACAnalysis testing. These U.S. patents have terms that are expected to expire commencing in 2014, with the last patent expected to expire in 2029. BART: The company owns or has license rights to seven issued U.S. patents relating to BART testing. These U.S. patents have terms that are expected to expire commencing in 2015, with the last patent expected to expire in 2025. COLARIS: The company owns or has exclusive or non-exclusive license rights to 19 issued U.S. patents relating to COLARIS testing. These U.S. patents have terms that began to expire commencing in 2013, with the last patent expected to expire in 2023. COLARIS AP: The company owns or has exclusive license rights to 11 issued U.S. patents relating to COLARIS AP testing. These U.S. patents have terms that are expected to expire commencing in 2017, with the last patent expected to expire in 2026. myRisk Hereditary Cancer: The company owns or has license rights to 54 issued U.S. patents and 3 pending U.S. patent applications relating to myRisk Hereditary Cancer testing. Subject to applicable extensions, the company anticipates that the expiration dates of these patents would commence in 2014, with the last patent, if issued from the pending applications, expected to expire in 2029. Governmental Regulation As a condition of the Clinical Laboratory Improvement Amendments of 1988 certification, each of the company’s laboratories is subject to survey and inspection every other year, in addition to being subject to additional random inspections. The company’s laboratories are accredited by the College of American Pathologists, which are the Centers for Medicare & Medicaid Services-approved accreditation organization. The company is subject to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) regulations and maintains an active compliance program that is designed to identify security incidents and other issues in a timely fashion and enable the company to remediate, mitigate harm or report if required by law. The company is subject to prosecution and/or administrative enforcement and increased civil and criminal penalties for non-compliance, including a new, four-tiered system of monetary penalties adopted under the Health Information Technology for Economic and Clinical Health Act (HITECH). The company is also subject to enforcement by state attorneys general who were given authority to enforce HIPAA under HITECH. The company is also required to maintain information and control through sales and distributors’ activities that might fall within the purview of the Foreign Corrupt Practices Act, its books and records provisions, and its anti-bribery provisions. History Myriad Genetics, Inc. was founded in 1991.
myriad genetics inc (MYGN:NASDAQ GS)
320 Wakara Way
Salt Lake City, UT 84108
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