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AbbVie Expands CDx Deal with Myriad to Use Tumor BRCA Test in Veliparib Trials

NEW YORK (GenomeWeb) – Myriad Genetics and drug developer AbbVie have expanded their existing companion diagnostics collaboration and agreed to use in clinical studies a version of BRACAnalysis that gauges somatic BRCA1 and BRCA2 mutations in cancer patients' tumors.

AbbVie and Myriad inked a deal in 2010 to use Myriad's standard BRACAnalysis test for assessing germline mutations from cancer patients' blood samples as a companion diagnostic in clinical trials for the investigational PARP inhibitor veliparib. AbbVie has been using the germline test in late-stage studies to identify patients with BRCA mutations who are likely to be best responders to the drug. AbbVie is studying veliparib in various tumor types characterized by BRCA mutations, including advanced breast cancer and non-small cell lung cancer.

In the latest extension of their agreement, AbbVie will use the so called Tumor BRACAnalysis CDx in Phase III trials of veliparib, hoping to identify a greater number of patients who have BRCA mutations and who will benefit from treatment. According to studies, the tissue-based test can identify 50 percent more patients with BRCA mutations compared to germline testing.

Myriad is planning to launch the Tumor BRACAnalysis CDx in Europe first and recently established a lab in Munich toward that end. Ideally, the company is hoping to launch Tumor BRACAnalysis in tandem with the commercialization of AstraZeneca's PARP inhibitor olaparib. The European Medicines Agency's Committee for Medicinal Products for Human Use recently recommended marketing authorization for olaparib for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.

In the US, Myriad is planning to perform tumor BRCA testing in its lab in Salt Lake City, Utah. Although Myriad's CDx deal with AstraZeneca is the most advanced, the company hasn't provided a definite timeline for when it plans to launch the tumor CDx on this side of the pond. Currently, its collaboration in the US with AstraZeneca remains focused on the use of germline BRCA testing to identify best responder to olaparib.