Invivoscribe Technologies Inc. announced the expansion of its long-term collaboration agreement with Thermo Fisher Scientific to include development and commercialization of in vitro diagnostic (IVD) assays for the Applied Biosystems® 3500 Dx Series Genetic Analyzers. The company's previously announced agreement focuses on the development of IVD oncology tests for the Ion PGM™ Dx System. Under terms of the expanded agreement, Invivoscribe will seek FDA approval of a FLT3 Mutation Assay, as well as clearance of a number of B- and T-cell clonality and immuno-oncology assay kits that will run on the 3500 Dx capillary electrophoresis platform. The Invivoscribe FLT3 mutation assay is a signal ratio assay that identifies both internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations, and identifies even large ITD mutations, which are missed using many current NGS-based assays. FLT3 is the single most important biomarker for the stratification and prognosis of acute myeloid leukemia (AML), the most deadly form of leukemia, which is diagnosed in about 20,000 new patients each year in the U.S. and has only a 25%-40% five-year survival rate. Invivoscribe, working under a companion diagnostic agreement with Novartis, has developed a companion diagnostic for FLT3 that is currently under FDA review for use with PKC412 (midostaurin) an investigational drug in development for adults with newly-diagnosed AML who are FLT3 mutation-positive. This investigational compound was granted a Breakthrough Therapy designation by the US FDA in early 2016. The Invivoscribe LeukoStrat® CDx FLT3 Mutation Assay would be the first molecular companion diagnostic in AML.