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Invivoscribe, Thermo Fisher to Develop FLT3 Mutation, Clonality Assay Kits

NEW YORK (GenomeWeb) – Invivoscribe Technologies said today that it is expanding its long-term collaboration agreement with Thermo Fisher Scientific to include development and commercialization of in vitro diagnostic assays for the Applied Biosystems 3500Dx genetic analyzer.

The companies initially agreed a year ago to co-develop oncology tests for the Ion PGM Dx System. Now, under the expanded terms of the deal, Invivoscribe said it plans to seek US Food and Drug Administration approval or clearance for a number of specific assays, including an FLT3 mutation test and several B- and T-cell clonality and immuno-oncology assay kits to run on the 3500Dx capillary electrophoresis platform.

Invivoscribe's FLT3 companion diagnostic test is currently under FDA review for use with Novartis' investigation drug midostaurin, for adults with newly-diagnosed AML who are FLT3 mutation-positive.

Invivoscribe CEO and CSO Jeffrey Miller said in a statement that the expanded agreement with Thermo Fisher will now allow his company to move forward with launching additional IVD assays to "help healthcare providers identify, stratify, and optimize treatment for their patients with hematologic malignancies."

Additional details of the arrangement were not disclosed.