SAN DIEGO, Nov. 19, 2018 (GLOBE NEWSWIRE) -- In support of an ongoing partnership with Daiichi Sankyo, Invivoscribe is pleased to announce submission of the LeukoStrat® CDx FLT3 Mutation Assay to the PMDA (Pharmaceuticals and Medical Devices Agency) as the companion diagnostic for quizartinib, which follows Daiichi Sankyo’s PMDA application for quizartinib in Japan.
Invivoscribe developed the LeukoStrat CDx FLT3 Mutation Assay in partnership with Daiichi Sankyo as the companion diagnostic that bridges to the global phase 3 QuANTUM-R clinical trial (Europe, United States, Asia excluding Japan) in patients with relapsed/refractory FLT3 ITD AML. Together, QuANTUM-R clinical trial and open-label phase 2 study of quizartinib (Japan) support the Daiichi Sankyo New Drug Application (NDA) to Japan’s MHLW/PMDA for marketing approval of quizartinib for the treatment of adult patients with relapsed/refractory FLT3 ITD acute myeloid leukemia (AML).
This submission complements Invivoscribe’s prior regulatory approvals of this LeukoStrat CDx FLT3 Mutation Assay as an AML companion diagnostic in support of midostaurin for Novartis (United States and Europe), and gilteritinib fumarate for Astellas (Japan). Astellas and Invivoscribe have also submitted applications for the drug and device to the CDER and CDRH, respectively, in the United States.
This milestone helps to further establish the LeukoStrat CDx FLT3 Mutation Assay as the international standard for comprehensive FLT3 assessment for critically ill acute myeloid leukemia patients as this CDx is available worldwide and generates standardized signal ratios for both ITD and TKD mutations. These criteria are already resulting in more consistent stratification of patients which will help prescribing doctors identify personalized therapy options for their patients and accelerate new drug and therapy approvals by establishing more homogeneous patient populations for clinical trials.
Timing of this submission also reflects the efficiencies of Invivoscribe’s Streamlined CDx™ program, which provides pharmaceutical partners with integration of activities including CDx development, clinical trials support with rapid patient screening for enrollment, regulatory support and commercialization. Combining many of these activities can accelerate drug approvals as well as ensure rapid availability of the drugs to the appropriate patients following approvals.
The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based, in vitro diagnostic test designed to 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 acute myelogenous leukemia. This globally standardized test includes software that interprets data, generates mutant/wildtype signal ratios for ITD and TKD mutations, and predicts response to both gilteritinib fumarate and midostaurin. This extensively validated assay helps standardize the detection of genetic mutations in the FLT3 gene as one of the most important driver mutations in Acute Myeloid Leukemia (AML). In serving as the companion diagnostic to the Daiichi Sankyo sponsored clinical trials, this test reports out FLT3 ITD mutations alone.
The LeukoStrat test is currently available as a test menu service through the Invivoscribe subsidiaries, LabPMM LLC (San Diego, CA, US), LabPMM GmbH (Martinsried, Germany) and LabPMM GK (Kawasaki City, Japan). LeukoStrat CDx FLT3 Mutation Assay kits are currently distributed in Europe. Distribution of kits in Japan, United States, and China are planned.
Invivoscribe is a privately held biotechnology company dedicated to Improving Lives with Precision Diagnostics™. For nearly twenty-five years, Invivoscribe has improved 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, and provides expertise in both regulatory and laboratory services. Providing distributable kits, as well as clinical trial services through its globally located clinical lab subsidiaries (LabPMM), Invivoscribe is an ideal partner from diagnostic development through clinical trials and regulatory submissions. For additional information please contact Invivoscribe at support@invivoscribe.com or visit www.invivoscribe.com.