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Myriad Genetics Using BRACAnalysis as CDx for Tesaro Cancer Drug

NEW YORK (GenomeWeb News) – Myriad Genetics said after the close of the market on Monday that it has signed an agreement to provide its BRACAnalysis test as a companion diagnostic for a cancer therapeutic being developed by Tesaro.

Under the terms of the deal, the BRCA1 and BRCA 2 test will be used in two separate Phase III clinical trials with niraparib, a novel, orally active poly (ADP ribose) polymerase, or PARP, inhibitor. One trial, in platinum-sensitive, high-grade serous ovarian cancer patients, is slated to begin enrollment in the middle of this year. A second trial, in metastatic breast cancer patients who have germline BRCA mutations, will begin in the second half of the year.

"We believe this agreement reinforces BRACAnalysis as the gold standard companion diagnostic test for this exciting new class of therapeutics," Myriad President and CEO Peter Meldrum said in a statement.

Financial and other terms of the deal were not disclosed.

Myriad recently submitted an investigational device exemption application with the US Food and Drug Administration for BRACAnalysis, laying the regulatory groundwork for the test to be studied in five pivotal trials to pick out best responders to AstraZeneca's PARP inhibitor olaparib, according to Pharmacogenomics Reporter. While it is Myriad's first IDE submission, the firm has companion diagnostic deals with several other biopharma firms, including Abbott Laboratories, Cephalon, BioMarin, and PharmaMar.

The agreement with Tesaro comes on the heels of the US Supreme Court's decision two weeks ago that isolated human genes are not patentable — a case that centered on Myriad's patents covering the BRCA1 and BRCA2 genes. The court, however, found that synthetic DNA is patent eligible.

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