Invivoscribe has secured approval from the Japan’s Ministry of Health, Labor and Welfare (MHLW) for its LeukoStrat CDx FLT3 mutation assay as the companion diagnostic (CDx) for Daiichi Sankyo’s Quizartinib to treat FLT3-ITD positive relapse/ refractory acute myeloid leukemia (AML) patients.
LeukoStrat CDx FLT3 is a PCR-based and in vitro diagnostic test, which will help detect internal tandem duplication (ITD) mutations and tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with AML.
Available across the globe, the test uses software that can interpret data and generate standardized mutant / wildtype signal ratios for ITD and TKD mutations, as well as predict response to multiple tyrosine kinase inhibitors.
According to the company, the Japanese MHLW added approval in use of EDTA collection tubes to the existing approval of heparin collection tubes used with this assay.
The QuANTUM-R study showed that quizartinib resulted in a statistically significant improvement in overall survival (OS) compared against salvage chemotherapy when patients have been selected with the LeukoStrat CDx FLT3 mutation assay.
Invivoscribe CSO and CEO Dr Jeffrey Miller said: “Once again, our Streamlined CDx program has demonstrated its effectiveness in accelerating submissions and approvals for our partners worldwide.
“Invivoscribe welcomes opportunities to partner with global pharmaceutical companies interested in developing and commercializing companion diagnostics, whether their therapies are targeting hematologic diseases or solid tumors.”
Invivoscribe is providing LeukoStrat test as test menu through its wholly-owned subsidiaries, LabPMM in the US, LabPMM in Germany and LabPMM GK in Japan.
More than 95% of patient samples tested using the FDA-approved LeukoStrat CDx FLT3 mutation assay and selection of other CLIA-validated PCR-based capillary assays provide results within 48 hours of sample receipt at any of the LabPMM laboratories, said the company,
At present, LeukoStrat CDx FLT3 mutation assay kits are sold in Japan, Europe, and Australia, and plans are underway to distribute in the US and China.
Invivoscribe is a global and vertically-integrated biotechnology firm, which offers distributable kits and clinical trial services through its globally located clinical lab subsidiaries.