Wednesday, May 3, 2017

INVIVOSCRIBE® RECEIVES FDA APPROVAL FOR THE LEUKOSTRAT® CDX FLT3 MUTATION ASSAY COMPANION DIAGNOSTIC TEST FOR THE SELECTION OF PATIENTS FOR RYDAPT® AND IS THE FIRST COMPANION DIAGNOSTIC FOR AML

SAN DIEGO, May 2 (Bernama-GLOBE NEWSWIRE) -- Invivoscribe® Technologies Inc., a global company with more than 20 years of experience providing clonality and biomarker test solutions for the fields of oncology, personalized molecular diagnostics® and personalized molecular medicine®, today announces the premarket approval of LeukoStrat&3174; CDx FLT3 Mutation Assay. Due to current labeling for the FDA approved test, FLT3 mutation testing with LeukoStrat® CDx FLT3 Mutation Assay is exclusively performed by The Laboratory for Personalized Molecular Medicine, a subsidiary of Invivoscribe Technologies, Inc., which has gained FDA approval for its FLT3 test as a companion diagnostic for the Novartis drug Rydapt® in newly diagnosed FLT3 AML.

Under terms of a previously announced agreement with Thermo Fisher, Invivoscribe will also seek FDA approval of the LeukoStrat® CDx FLT3 Mutation Assay that will allow the sale of kits to other laboratories. The Invivoscribe LeukoStrat® CDx 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.
http://mrem.bernama.com/viewsm.php?idm=29005

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