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Myriad Expands CDx Collaboration with AstraZeneca, Builds New Lab

NEW YORK (GenomeWeb News) – Myriad Genetics announced that it will build a new laboratory at its Salt Lake City facility within which the company will develop companion diagnostics in line with US Food and Drug Administration's regulations.

The new lab build out, according to Myriad, expands its non-exclusive collaboration with AstraZeneca to study the drug olaparib in Phase III trials using Myriad's BRACAnalysis test to pick out best responders to the treatment. The partners did not disclose the specific terms of the expanded collaboration.

AstraZeneca is developing olaparib as a breast and ovarian cancer treatment for women with BRCA-mutated tumors. In August, the FDA approved Myriad's investigational device exemption for BRACAnalysis, which allows the company to use the test in human trials investigating olaparib.

At the American Society of Clinical Oncology's annual meeting in June, AstraZeneca released data from a pharmacogenomic subgroup analysis of a Phase II study. The data showed that cancer patients with germline or somatic BRCA mutations lived approximately seven more months without their cancer progressing when treated with olaparib compared to placebo. When the study investigators considered all patients with BRCA mutations (germline and somatic), they noted a trend favoring survival in those taking olaparib, although the difference between the olaparib and placebo arms was not significant.

AstraZeneca has previously stated that it plans to launch two Phase III trials involving olaparib in BRCA-mutated ovarian cancer in the third quarter of this year. One study will focus on olaparib as a maintenance therapy in the first-line setting in ovarian cancer patients with BRCA mutations, and a second trial will assess the drug in platinum-sensitive, relapsed ovarian cancer patients who harbor these mutations. According to AstraZeneca's website, the company is also investigating olaparib in breast cancer patients with BRCA mutations.

During its latest earnings call with investors and analysts, Myriad officials said that AstraZeneca is hopeful that it can garner approval for olaparib in the European market in the next 18 months. If the drug passes muster with EU regulators, Myriad could be looking to launch its first commercial companion diagnostic in early 2015.

In addition to its collaboration with AstraZeneca, Myriad has five other companion diagnostic arrangements with drug developers using its tests to pick out best responders to investigational DNA damaging agents.