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Myriad Enters Companion Diagnostics Field With An FDA First

Myriad Genetics' BRCA1/2 gene testing service has been approved as a companion diagnostic to AstraZeneca's new ovarian cancer drug, an important step in the company's diversification plan and a significant milestone in FDA's oversight of laboratory-developed tests.

Myriad Genetics Inc.'s strategy to remake the growth prospects for its BRACAnalysis gene testing service took a step in the right direction with the Dec. 19 FDA approval of its BRACAnalysis CDx assay as a companion diagnostic to AstraZeneca PLC’s ovarian cancer drug Lynparza (olaparib). The approval is also an important milestone in FDA's oversight of laboratory developed tests.

It is Myriad's first companion diagnostic approval for the BRCA1/2 genetic assay, resulting from an ongoing collaboration with AstraZeneca.

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