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March 6, 2013
07:10 EDTMYGNBRCA testing granted care designation under Affordable Care Act
Myriad Genetics announced that three federal agencies including the U.S. Department of Health and Human Services, the U.S. Department of Labor, and the U.S. Department of the Treasury have issued a set of FAQs clarifying BRCA testing as a preventive service under the provisions of the Affordable Care Act. Importantly, this clarification will allow for BRCA testing to be completed with no patient cost sharing for all non-grandfathered private insurance plans when an asymptomatic woman has a qualifying family history.
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December 19, 2014
12:12 EDTMYGNMyriad Genetics receives FDA approval of BRACAnalysis CDx
Myriad Genetics (MYGN) announced that it has received approval from the U.S. FDA for BRACAnalysis CDx to be used as the only companion diagnostic in conjunction with AstraZeneca's (AZN) drug Lynparza. Lynparza is the first poly ADP-ribose polymerase inhibitor for patients with germline mutations in BRCA1/2 advanced ovarian cancer who have had three or more lines of chemotherapy. BRACAnalysis CDx is Myriad's first FDA-approved companion diagnostic for use with a novel PARP inhibitor. BRACAnalysis CDx is a highly accurate molecular companion diagnostic test that identifies deleterious or suspected deleterious mutations in the BRCA1 and BRCA2 genes, using DNA obtained from a blood sample. BRACAnalysis CDx was proven in clinical studies to effectively identify patients with BRCA mutations who would be candidates for Lynparza. The approval of BRACAnalysis CDx demonstrates Myriad's commitment to developing companion diagnostics and is the culmination of an intensive, multiyear scientific collaboration with AstraZeneca to advance personalized medicine for women with ovarian cancer.
10:17 EDTMYGNOn The Fly: Analyst Initiation Summary
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07:15 EDTMYGNMyriad Genetics initiated with a Market Perform at Wells Fargo
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December 17, 2014
10:21 EDTMYGNMyriad denied appeal to block competing breast cancer tests, Bloombeg reports
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December 11, 2014
12:54 EDTMYGNMyriad Genetics management to meet with William Blair
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