NEW YORK (GenomeWeb) – Invivoscribe announced today that it has received approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA)for its LeukoStrat CDx FLT3 Mutation Assay companion diagnostic.
The firm expects to begin shipments of the FTL3 assay from LabPMM GK, the assay's marketing authorization holder in Japan, in late 2018.
Invivoscribe's test is the first companion diagnostic for acute myeloid leukemia and detects internal tandem duplications and tyrosine kinase domain mutations D835 and I836 in the FLT3 gene. The tool includes software that interprets data, generates mutant and wildtype signal ratios for ITD and TKD mutations, and predicts response to the drug gilteritinib fumarate (Xospata).
Invivoscribe previously submitted a pre-market approval application for the assay to Japan's PMDA and as a panel track supplement to the US Food and Drug administration in May.
"Test standardization is a critical part of precision medicine as it helps to refine treatments and accelerate drug approvals," Invivoscribe CEO and CSO Jeffrey Miller said in a statement. "These [regulatory] milestones represent a significant step towards standardized detection of one of the most important driver mutations in AML."
Invivoscribe previously released a CE-marked IVD version of the LeukoStrat assay in August 2017.