Invivoscribe^® Inc., a global company providing biomarker and clonality test solutions for the fields of oncology and personalized molecular medicine^® today announces Pharmaceuticals and Medical Devices Agency (PMDA) approval of the LeukoStrat CDx FLT3 Mutation Assay companion diagnostic.

As the first company to receive both FDA and PMDA approval for an acute myeloid leukemia (AML) companion diagnostic, Invivoscribe continues our mission for global standardization of diagnostic testing and expanding our global laboratory network.

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/wildtype signal ratios for ITD and TKD mutations, and predicts response to gilteritinib fumarate.

Invivoscribe developed this companion diagnostic 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 leukemia¹. This companion diagnostic screened subjects for enrollment eligibility into the Phase 3 ADMIRAL study evaluating gilteritinib fumarate for the treatment of FLT3 mutation-positive (FLT3 mut+) relapsed or refractory AML adult patients.

The LeukoStrat CDx FLT3 Mutation Assay is available as a commercial service offering from LabPMM 合同会社 in Japan to identify FLT3 mut+ AML patients for possible Xospata^® treatment.  Distributable LeukoStrat CDx FLT3 Mutation Assay Kits are expected to begin shipment from LabPMM 合同会社, the Marketing Authorization Holder (MAH) in Japan, in late 2018.

“Invivoscribe has long been committed to international standardization of molecular diagnostic tests. 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 Jeffrey Miller, CSO & CEO of Invivoscribe.

Invivoscribe is a privately held biotechnology company dedicated to improving the quality of healthcare worldwide by providing high quality, standardized reagents, tests, and bioinformatics tools to advance the field of precision medicine. Invivoscribe has a successful track record of partnerships with global pharmaceutical companies interested in developing and commercializing companion diagnostics. LabPMM 合同会社 is an accredited subsidiary of Invivoscribe.

For additional information please contact LabPMM 合同会社 at [email protected] or visit www.invivoscribe.com/clinical-services.

1) Papaemmanuil E, Gerstung M, Bullinger L, et al.N Engl J Med 2016; 374(23):2209-2221