KUALA LUMPUR, Sept 28 (Bernama) -- Invivoscribe® Inc has been approved by Pharmaceuticals and Medical Devices Agency (PMDA), Japan for its LeukoStrat CDx FLT3 Mutation Assay companion diagnostic.
Invivoscribe is a global company that provides biomarker and clonality test solutions for the fields of oncology and personalized molecular medicine.
The biotechnology company is the first to receive both FDA and PMDA approval for an acute myeloid leukemia (AML) companion diagnostic.
The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detect internal tandem duplications (ITD) and tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 gene.
The globally standardized test includes software that interprets data, generates mutant/wild type signal ratios for ITD and TKD mutations and predicts response to gilteritinib fumarate.
The company in a statement said, the companion diagnostic has been developed as an aid in identifying FLT3 mut+ AML patients eligible for treatment with gilteritinib fumarate (Xospata®).
The company in a statement said, the companion diagnostic has been developed as an aid in identifying FLT3 mut+ AML patients eligible for treatment with gilteritinib fumarate (Xospata®).
FLT3 somatic variants are among the most common driver mutations with the strongest effects on the overall survival in acute myeloid leukemia.
The LeukoStrat CDx FLT3 Mutation Assay is available as a commercial service offering from LabPMM GK in Japan to identify FLT3 mut+ AML patients for possible Xospata® treatment.
The Distributable LeukoStrat CDx FLT3 Mutation Assay Kits are expected to begin shipment from LabPMM GK, the Marketing Authorization Holder (MAH) in Japan, in late 2018.
“Test standardization is a critical part of precision medicine as it helps to refine treatments and accelerate drug approvals. Approval of our LeukoStrat CDx FLT3 Mutation Assay in Japan follows on the approval of the same test by the FDA in the US last year. These milestones represent a significant step towards standardized detection of one of the most important driver mutations in AML”, said chief scientific officer and chief executive officer of Invivoscribe, Jeffrey Miller.
--BERNAMA
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