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NEW YORK (GenomeWeb) – The US Food and Drug Administration has approved Myriad Genetics' BRACAnalysis CDx for determining which HER2-negative, metastatic breast cancer patients have inherited BRCA1 and BRCA2 genetic mutations and therefore may benefit from treatment with Pfizer's Talzenna (talazoparib).

The companion diagnostic approval accompanied the regulatory approval of Pfizer's PARP inhibitor Talzenna. Talzenna is indicated as a treatment for advanced or metastatic breast cancer patients who have BRCA mutations as determined by an FDA-approved companion diagnostic.

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