NEW YORK ─ Invivoscribe said this week it has received an approval from the US Food and Drug Administration that enables it to distribute its LeukoStrat CDx FLT3 Mutation Assay as an in vitro diagnostic kit in the US.
This premarket approval (PMA) supplement gives its customers an option to purchase the IVD-labeled LeukoStrat CDx FLT3 Mutation Assay with analysis software for in-house testing, Invivoscribe said.
The ability to perform efficient, accurate, and objective FLT3 testing at regional laboratories, cancer treatment centers, and hospitals is expected to improve the management of patients diagnosed with acute myelogenous leukemia (AML), the firm added.
The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based test that detects internal tandem duplication and tyrosine kinase domain mutations D835 and I836 in the FLT3 gene in DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with AML.
The FDA had approved the FLT3 test in 2017, and Invivoscribe had launched it as part of a testing service at its clinical laboratory in San Diego.