BRACAnalysis CDx Approved in US as Companion Diagnostic Test for First-line Lynparza Treatment

BRACAnalysis CDx Approved in US as Companion Diagnostic Test for First-line Lynparza Treatment
Myriad GeneticsBRACAnalysis CDx has been approved by the U.S. Food and Drug Administration as a companion diagnostic test to identify women with ovarian cancer eligible for first-line maintenance treatment with Lynparza (olaparib). Lynparza was recently approved for patients who had a partial or complete response to first-line platinum-based chemotherapy and have inherited mutations in their BRCA genes. BRACAnalysis CDx is meant to identify these mutations and guide patient management. This is the fifth approval of BRACAnalysis CDx as a companion diagnostic test for Lynparza, including to identify ovarian cancer patients eligible for second-line and fourth-line treatment with Lynparza and for some breast cancer indications. “We congratulate AstraZeneca and Merck on obtaining FDA approval of Lynparza for patients with BRCA [mutated] advanced ovarian cancer, and we are excited to expand the use of BRACAnalysis CDx as the companion diagnostic test in this population,” Lloyd Sanders, president of Myriad Oncology, said in a press release. “We estimate there are more than 20,000 patients newly diagnosed with ovarian cancer in the United States every year who qualify for a BRACAnalysis CDx test.” Ly
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