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FDA approves Myriad test as a CDx for Lynparza

Jan. 17, 2018Myriad Genetics announced that the FDA approved BRACAnalysis CDx for use as a companion diagnostic to identify patients with HER2-negative metastatic breast cancer who have a germline BRCA mutation and are candidates for treatment with the PARP inhibitor Lynparza (olaparib), marketed by AstraZeneca and Merck. BRACAnalysis CDx is the first FDA-approved test for use in this indication.

“This important advance underscores the need for patients with HER2-negative metastatic breast cancer to know their BRCA status with an FDA-approved test to help ensure that they will receive the best available therapy,” Johnathan Lancaster, MD, PhD, chief medical officer of Myriad Genetics, said in a statement. “As shown in the OlympiAD study, Myriad’s BRACAnalysis CDx test was proven to accurately identify those patients who had a germline BRCA mutation and may benefit from Lynparza.”

Lynparza (olaparib) is a poly ADP-ribose polymerase inhibitor that exploits tumor DNA damage response pathway deficiencies to preferentially kill cancer cells.

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