Myriad Genetics (MYGN) Files For MyChoice CDx Test SPMA
Zacks Investment Research | Feb 12, 2020 10:36PM ET
Myriad Genetics, Inc. (NASDAQ:MYGN) recently submitted a supplementary premarket approval (sPMA) application to the FDA for its myChoice CDx test. This will enable the identification of women suffering from advanced ovarian cancer who are prospective candidates for maintenance therapy with Lynparza (olaparib) in combination with bevacizumab.
With the receipt of approval, the company will take a major stride forward in its Oncology and Women’s Health segment.
More About myChoice CDx
myChoice CDx is the most wide-ranging homologous recombination deficiency test, helping physicians identify patients with tumors, who have increased exposure to DNA-damaging drugs such as platinum drugs or PARP inhibitors.
The company filed for the sPMA on the basis of favorable outcomes from the Phase 3 PAOLA-1 clinical trial of Lynparza that was published online in December 2019. The sPMA would ensure better outcomes for ovarian cancer patients through precision medicine and targeted therapies.
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