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Japan’s MHLW Approves Invivoscribe’s LeukoStrat CDx FLT3 Mutation Assay as the CDx for Daiichi Sankyo’s Quizartinib for Treatment of Relapsed/Refractory FLT3-ITD AML. Expands Use to Include Specimens Collected in EDTA

June 19, 2019 Off By BusinessWire

SAN DIEGO–(BUSINESS WIRE)–Invivoscribe is pleased to announce that on June 5^th the
Ministry of Health, Labor and Welfare (MHLW) approved our LeukoStrat^®
CDx FLT3 Mutation Assay as the companion diagnostic for
Daiichi Sankyo’s Quizartinib for the treatment of FLT3-ITD
positive relapse/ refractory acute
myeloid leukemia (AML) patients in Japan. At the same time 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 demonstrated that quizartinib resulted in a
statistically significant improvement in overall survival (OS) compared
to salvage chemotherapy when patients were selected with the LeukoStrat
CDx FLT3 Mutation Assay. Mutations in the FLT3 gene are
among the most important driver mutations in AML.

This milestone further establishes the LeukoStrat CDx FLT3
Mutation Assay as the international gold standard for comprehensive FLT3
assessment for critically ill AML patients.

This PCR-based, in vitro diagnostic test detects 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. This test, which is available
worldwide, includes software that interprets data, generates
standardized mutant/wildtype signal ratios for ITD and TKD mutations,
and predicts response to multiple tyrosine kinase inhibitors.

“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.” said Dr. Jeffrey Miller,
Invivoscribe’s CSO and CEO.

The LeukoStrat test is available as a test menu service through
Invivoscribe’s wholly-owned subsidiaries, LabPMM
LLC (San Diego, CA, U.S.), LabPMM GmbH (Martinsried, Germany) and
LabPMM GK (Kawasaki City, Japan). Greater 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 report
out results within 48 hours of sample receipt at any of the LabPMM
laboratories. LeukoStrat CDx FLT3 Mutation Assay kits
are currently distributed in Japan, Europe, and Australia, and are
planned for distribution in the United States and China in the future.

About Invivoscribe

Invivoscribe is a global, vertically-integrated 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, regulatory submissions,
and commercialization.