Myriad Genetics, Inc., a molecular diagnostic company, focuses on developing and marketing novel predictive medicine, personalized medicine, and prognostic medicine tests. The company performs all of its molecular diagnostic testing and analysis in its own reference laboratories. Business Strategy The company’s business strategy is to understand the relationship between genes and their protein products and human diseases to develop the next generation of molecular diagnostic tests. Its business strategy includes various primary elements, including discovering primary DNA, RNA, and protein biomarkers, understand their function and determine their role in human disease; acquiring promising biomarkers from other organizations; independently developing and commercializing new transformative molecular diagnostic tests; growing its molecular diagnostic business in the United States across multiple disease indications; and expanding its molecular diagnostic business internationally. Molecular Diagnostic Tests The company’s molecular diagnostic tests are designed to analyze genes, their mutations, expression levels, and proteins to assess an individual’s risk for developing disease later in life, determine a patient’s likelihood of responding to a particular drug, assess a patient’s risk of disease progression and disease recurrence, and measure a patient’s exposure to drug therapy to ensure optimal dosing and reduced drug toxicity. As of June 30, 2012, the company launched nine commercial molecular diagnostic tests. It markets these tests through its own sales force in the United States. It also markets its BRACAnalysis, COLARIS, and COLARIS AP tests through its own European sales force and has entered into marketing collaborations with other organizations in selected Latin American, European, and Asian countries. The company engages in providing companion diagnostic services to the pharmaceutical and biotechnology industries, and medical research institutions utilizing its multiplexed immunoassay technology. BRACAnalysis: Predictive Medicine Test for Hereditary Breast and Ovarian Cancer The company’s BRACAnalysis test is an analysis of the BRCA1 and BRCA2 genes for assessing a woman’s risk of developing hereditary breast and ovarian cancer. The company owns or has license rights to 525 claims in 24 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. COLARIS: Predictive Medicine Test for Hereditary Colorectal Cancer and Uterine Cancer The company’s COLARIS test is an analysis of the MLH1, MSH2, MSH6, and PMS2 genes for assessing a person’s risk of developing colorectal cancer or uterine cancer. It owns or has licensed rights to eight U.S. patents covering COLARIS testing. These U.S. patents have terms that are expected to expire commencing in 2013, with the last patent expected to expire in 2023. COLARIS AP: Predictive Medicine Test for Hereditary Colorectal Cancer The company’s COLARIS AP test detects mutations in the APC and MYH genes, which cause a colon polyp-forming syndrome known as familial adenomatous polyposis (FAP), a common variation of the syndrome known as attenuated FAP, and the MYH-associated polyposis signature (multi-analyte profile (MAP)). It owns or has rights to 10 U.S. patents covering 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. MELARIS: Predictive Medicine Test for Hereditary Melanoma The company’s MELARIS test analyzes mutations in the p16 gene to determine genetic susceptibility to malignant melanoma. It owns or has license rights to five U.S. patents covering MELARIS testing. These U.S. patents have terms that are expected to expire commencing in 2014, with the last patent expected to expire in 2023. OnDose: Personalized Medicine Test for Chemotherapy Toxicity to 5-FU (fluorouracil) The company’s OnDose test is a nanoparticle immunoassay that is designed to assist oncologists in optimizing 5-FU anti-cancer drug therapy in colon canc