Myriad's BRACAnalysis CDx gains FDA approval as companion diagnostic for ovarian cancer drug

Myriad Genetics announced Friday that its BRACAnalysis CDx received FDA approval to be used as a companion diagnostic test in conjunction with AstraZeneca's ovarian cancer drug Lynparza (olaparib). Company president Mark Capone said "Myriad is excited to offer the first and only FDA-approved companion diagnostic for Lynparza." He added that "less than 25 percent of ovarian cancer patients know their germline BRCA status, which is critical for any ovarian cancer patient who may be considered for treatment with Lynparza."

According to Myriad, the in vitro diagnostic uses DNA obtained from a blood sample to identify deleterious or suspected deleterious mutations in the BRCA1 and BRCA2 genes by polymerase chain reaction and Sanger sequencing. Test results are used as an aid to identify patients with ovarian cancer eligible for treatment with Lynparza.

Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, said "the BRACAnalysis CDx is the FDA's first approval of an LDT [laboratory developed test] under a premarket approval application and is the first approval of an LDT companion diagnostic." The agency noted that the device's clearance was based on clinical study data used to support approval of Lynparza, in which participants' blood samples were tested to validate the test’s use for detecting BRCA mutations.

Myriad recently lost an appeal in the US to block competing products to its BRCA gene sequencing tests, which is also used to determine risk for breast cancer.

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