Invivoscribe® Technologies Inc., a global company with decades of experience providing clonality and biomarker test solutions for the fields of oncology and personalized molecular medicine®, today announces the release of the CE-marked IVD version of its LeukoStrat® CDx FLT3 Mutation Assay which earlier this year was approved by the FDA1.
The assay identifies both internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations, and identifies even large ITD mutations, missed using many current NGS-based assays. The kit includes CE-marked software that interprets data, generates mutant/wildtype signal ratios for ITD and TKD mutations, and predicts response to midostaurin.
Invivoscribe will also seek FDA approval of the LeukoStrat® CDx FLT3 Mutation Assay to allow the sale of kits to laboratories in the United States.
The Invivoscribe LeukoStrat® CDx FLT3 Mutation Assay is the first companion diagnostic for AML, and the only commercially available signal ratio assay validated in international clinical trials so the results generated are harmonized for healthcare providers worldwide. It is currently being utilized for enrollment in multiple international clinical trials.
Mutations in FLT3 are among the most common driver mutations, with the strongest effects on the overall survival in acute myeloid leukemia2 (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 26.9 percent five-year survival rate3.
“Release of this CE-marked IVD signal ratio assay 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. “Further, as has been noted by others4, there is a need for an internationally standardized FLT3 mutation assay and release of this product helps fulfill that need.”
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, that when used in combination with Invivoscribe’s proprietary MyInformatics® Software can identify and 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 tests, reagents and bioinformatics tools are currently being used in more than 700 clinical and research laboratories in more than 102 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 ce.flt3cdx.com.
2. Papaemmanuil E, Gerstung M, Bullinger L, et al. N Engl J Med 2016;374(23):2209-2221
4. Levis, M. Hematology Am Soc Hematol Educ Program 2013;2013:220-6