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News Breaks
February 18, 2014
07:19 EDTMYGNProlaris test predicted which men would develop BCR after prostate surgery
Myriad Genetics announced it has published data in the Journal of Urology demonstrating that its Prolaris test accurately predicted, based on biopsy specimens, which men would develop biochemical recurrence, or BCR, or metastatic disease following radical prostate surgery. Prolaris is a 46-gene molecular diagnostic test that has been evaluated in more than 5,000 patients across 11 clinical studies. The study evaluated biopsy specimens in 582 men who were treated by radical prostatectomy. In the study, biopsy samples were evaluated from three cohorts of contemporary patients in the United States and Germany. The clinical endpoints were metastatic disease and BCR. In all cohorts, the Prolaris test was a statistically significant predictor of BCR and was the single strongest predictor of metastatic disease when compared to Gleason Score or PSA. In the pooled analysis, each one-unit increase in the Prolaris score translated into a fivefold increased risk of metastases and a 1.6-times increased risk of BCR.
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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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