myriad genetics inc (MYGN) Key Developments
Myriad Genetics Inc. Announces Executive Changes
Dec 22 14
Myriad Genetics Inc. announced the appointment of Bernard F. Tobin as president of Crescendo Bioscience, effective January 5, 2015. Mr. Tobin will report to Peter D. Meldrum, president and CEO, Myriad Genetics Inc., and will succeed William Hagstrom, who has chosen to pursue new start-up business and social venture opportunities. Mr. Hagstrom will remain with the company until January 2, 2015 to ensure a smooth transition in leadership. As the new leader of Crescendo Bioscience, Mr. Tobin will leverage its strong expertise in rheumatoid arthritis (RA) to drive new growth opportunities for Vectra® DA, including obtaining private payer coverage in the United States and expanding the business internationally. In addition, Mr. Tobin will focus on new products from Crescendo's robust pipeline of novel molecular diagnostics for other autoimmune disorders. Mr. Tobin held several senior positions at Amgen over the past seven years, including Executive Director of National Accounts, General Manager of both the Netherlands and Brazil and Global Head of Commercial Excellence.
Myriad Receives FDA Approval of BRACAnalysis CDx(TM) as Companion Diagnostic for Lynparza(TM) (olaparib) in Ovarian Cancer Patients
Dec 19 14
Myriad Genetics Inc. announced that it has received approval from the U.S. Food and Drug Administration (FDA) for BRACAnalysis CDx to be used as the only companion diagnostic in conjunction with AstraZeneca's drug Lynparza (olaparib). Lynparza is the first poly ADP-ribose polymerase (PARP) 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.
TESARO, Inc. and Myriad Genetics Announce Companion Diagnostics Collaboration
Nov 20 14
TESARO Inc. and Myriad Genetics announced a collaboration utilizing Myriad's myChoice HRD companion diagnostic (CDx) to identify tumor tissue with a deficiency in homologous recombination. Under the terms of the agreement, TESARO will utilize Myriad's test to enrich the target population for potential responders to niraparib. Myriad will provide testing services and pursue necessary regulatory approvals in support of TESARO's development of niraparib.
Myriad Genetics Announces Encouraging Results from Melanoma Study
Nov 13 14
Myriad Genetics Inc. has announced encouraging results from a prospective clinical utility study of its Myriad myPath Melanoma test. Myriad myPath Melanoma is a genetic test that differentiates malignant melanoma from benign skin lesions across all major melanoma subtypes. Key findings of this clinical utility study included a 43% reduction in indeterminate diagnoses and a 49% change in physicians' treatment recommendations for patients. Overall, changes in treatment recommendations were observed in 49.1% of difficult-to-diagnose cases. In 39.4% of patients receiving a benign test result, recommendations were downgraded to less invasive treatment. Conversely, in 45.8% of patients receiving a malignant test result, recommendations were upgraded to more invasive treatment.
Myriad myPath(TM) Melanoma Improves Diagnosis and Treatment Plans
Nov 7 14
Myriad Genetics Inc. presented results from a prospective clinical utility study of its Myriad myPath Melanoma test at the 2014 American Society of Dermatopathology (ASDP) annual meeting in Chicago, Ill. Myriad myPath Melanoma is a genetic test that differentiates malignant melanoma from benign skin lesions across all major melanoma subtypes. Key findings of this clinical utility study included a 43% reduction in indeterminate diagnoses and a 49% change in physicians' treatment recommendations for patients. The study evaluated the impact of the Myriad myPath Melanoma diagnostic test on dermatopathologists' diagnoses and intended treatment recommendations for 218 patients with pigmented skin lesions that were considered difficult to diagnose. The dermatopathologists recorded their diagnoses and treatment plans before and after receiving the myPath Melanoma test results.