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Myriad Will Seek FDA Approval of BRACAnalysis CDx as a Companion Diagnostic for Olaparib in this Patient Population

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Myriad Genetics, Inc., a leader in personalized medicine, today announced that the Phase III POLO study demonstrated its BRACAnalysis CDx®  test successfully identified patients with metastatic pancreatic cancer who have BRCA mutations and benefitted from treatment with olaparib, a novel PARP inhibitor.

Myriad plans to file a supplementary Premarket Approval (sPMA) application with the U.S. Food and Drug Administration (FDA) to authorize BRCAnalysis CDx as a companion diagnostic for olaparib in this indication and has an exclusive commercialization agreement.

“The results of the POLO trial strongly support use of the BRACAnalysis CDx test to help inform treatment decisions in the metastatic pancreatic cancer setting and will expand the patient population who can benefit from BRCA testing,” said Johnathan Lancaster, M.D., Ph.D., chief medical officer of Myriad Genetics.  “This study underscores Myriad’s commitment to our pharmaceutical partners and to advancing the field of personalized medicine for patients with cancer.” Read more . . .


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