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Abbott Using Myriad's BRACAnalysis to Stratify Patients for Phase III PARP Inhibitor Breast Cancer Trial


Originally published Oct. 26.

Myriad Genetics and Abbott Laboratories have signed an agreement to conduct BRCA1 and BRCA2 mutation testing on patients participating in a Phase III multi-center, international trial involving veliparib, an investigational metastatic breast cancer drug in Abbott's pipeline.

According to Myriad, the agreement is an extension of a previous deal between the two companies to conduct BRCA testing for veliparib in Phase II trials. Previously, Myriad said it was conducting BRCA testing to stratify best responders to the PARP inhibitor in metastatic breast cancer (PGx Reporter 06/30/10).

"Under the agreement, Myriad will use its BRACAnalysis test to identify the presence of germline mutations in the breast cancer patients to be enrolled in the study," the Salt Lake City, Utah-based company said. "Myriad will determine the mutation status of these patients and will provide standard test reports to the clinicians at each study site."

PARP inhibitors are a major area of focus for drug developers, and as such Myriad has inked companion diagnostic deals with not just Abbott, but also AstraZeneca, which is also developing a drug in this class, called olaparib.

The PARP1 enzyme and the BRCA gene work in concert to repair DNA damage, enabling the tumor to survive. However, in patients with mutations in the BRCA gene, when PARP inhibitors destroy the PARP1 enzyme, the tumor is unable to repair DNA damage and dies. The BRACAnalysis test can identify which patients have BRCA1/2 mutations and therefore would respond to PARP inhibitors.