FDAnews Device Daily Bulletin

Myriad’s BRACAnalysis CDx Test Identifies Patients Who Would Benefit from Olaparib

Oct. 27, 2016

Myriad Genetics revealed its BRACAnalysis CDx test accurately identified patients who may benefit from treatment with olaparib. 

The device was included in the SOLO2 study (NCT01874353) as a diagnostic with olaparib, an oral PARP inhibitor being developed by AstraZeneca.

In the clinical study, patients were tested for germline BRCA (gBRAC+) mutations as determined by Myriad’s BRACAnalysis CDx test, and the primary endpoint for SOLO2 was progression-free survival. — Cynthia Jessup

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