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Invivoscribe, Novartis Partner on Companion Dx for AML

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) –Invivoscribe announced on Tuesday a collaboration with Novartis to develop a companion diagnostic for acute myeloid leukemia patients.

The test will be for the identification of FLT3-positive AML patients for treatment with Novartis' midostaurin, or PKC412, a targeted small molecule inhibitor of FLT3 tyrosine kinase. The drug is currently in Phase III clinical development for newly diagnosed patients with FLT3 mutated AML.

About one-third of all AML patients have FLT3 mutations, which are associated with poor prognosis, Invivoscribe said. It added that the American Society of Clinical Oncology and the National Comprehensive Cancer Network recommend testing for the FLT3 mutation, and determination of FLT3 status has become a standard of care for patients diagnosed with AML.

Invivoscribe's subsidiary, the Laboratory for Personalized Molecular Medicine, is the only clinical laboratory with an exclusive license to the patents needed to generate FLT3 results that can be used for regulatory approval of a companion diagnostic, the San Diego-based firm said.

The company and the Laboratory for Personalized Molecular Medicine will work with Novartis to develop and manufacture the companion diagnostic. The three partners will also seek regulatory approval and collaborate on making the test available worldwide.

Financial and other terms of the deal were not disclosed.

Invivoscribe provides PCR-based reagents, CE-marked IVDs, and contract research organization services.