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Invivoscribe Releases LeukoStrat CDx FLT3 Mutation Assay as CE-marked IVD Assay Kit

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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 FDA.

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.”

Source: Invivoscribe