Invivoscribe receives FDA approval for the LeukoStrat CDx FLT3 mutation assay companion diagnostic test for the selection of patients for Rydapt

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® 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.

FLT3 somatic variants are among the most common driver mutations with the strongest effects on the overall survival in acute myeloid leukemia1 (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 26.6 percent five-year survival rate2. Invivoscribe, working under a companion diagnostic agreement with Novartis, developed this companion diagnostic for FLT3 successfully achieving FDA regulatory approval. The Invivoscribe LeukoStrat® CDx FLT3 Mutation Assay is the first companion diagnostic for AML.

"This test approval will be of substantial benefit to patients afflicted with AML and is a critical tool for healthcare providers to identify the most appropriate treatment for newly diagnosed FLT3-mutated AML patients, furthering the promise of personalized molecular diagnostics and precision medicine," said Dr. Jeffrey Miller, CSO & CEO of Invivoscribe. "And, as has been previously noted by others3, there is a need for an internationally standardized FLT3 mutation assay and this companion diagnostic is a step toward fulfilling that need."

About Invivoscribe

Invivoscribe® Technologies Inc. is a privately held biotechnology company dedicated to improving the quality of healthcare worldwide by providing high quality, reliable, cutting-edge reagents, tests, and bioinformatics tools to advance the fields of personalized molecular diagnostics® and personalized molecular medicine®. Invivoscribe provides ISO 13485 certified, PCR- and NGS-based reagents manufactured in a facility registered with FDA; RUO test kits; CE-marked IVDs, including IdentiClone® and LymphoTrack® Dx Assays with both LymphoTrack® and LymphoTrack® Dx Software; for clonality, MRD, and somatic hypermutation testing. Invivoscribe also offers comprehensive MyAML®, MyHeme®, MyMRD®, and custom gene panels. Used in combination with Invivoscribe's proprietary MyInformatics® Software these assays identify and can track primary driver mutations as well as the subclonal architecture and emergence of new driver mutations in patients with hematologic disease. Invivoscribe's clinical laboratories in the USA, Europe, and Japan provide international access to harmonized CLIA, CAP, and ISO 15189 accredited clinical testing and contract research organization (CRO) services.  Invivoscribe's clinical testing services, tests and reagents are currently being used in more than 650 clinical and research laboratories in 65 countries. Invivoscribe has long embraced the value of quality systems and develops all products, including bioinformatics software, compliant with ISO 13485 design control, making them eligible to be brought through regulatory process to authorities worldwide.  Additional information can be found at www.invivoscribe.com and www.flt3cdx.com.

References:

1. Papaemmanuil E, Gerstung M, Bullinger L, et al.  N Engl J Med 2016;374(23):2209-2221
2. https://seer.cancer.gov/statfacts/html/amyl.html
3. Levis, M. Hematology Am Soc Hematol Educ Program 2013;2013:220-6

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