PR98427

SAN DIEGO, Oct. 24, 2022 /PRNewswire=KYODO JBN/ --

Invivoscribe is pleased to announce that they have filed a supplemental

Pre-Market Approval (sPMA) submission with the U.S. Food and Drug

Administration (FDA) Center for Devices and Radiological Health (CDRH) for the

use of the LeukoStrat(R) CDx FLT3 Mutation Assay as the companion diagnostic

for Daiichi Sankyo's investigational drug quizartinib. The assay is used for

the identification of newly diagnosed acute myeloid leukemia (AML) patients

that have the FLT3-ITD mutation.

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The filing supports Daiichi Sankyo's new drug application (NDA) for quizartinib

for the proposed treatment of adult patients with newly diagnosed FLT3-ITD

positive AML, which was granted Priority Review by the FDA. Previously, the

LeukoStrat CDx FLT3 Mutation Assay was approved by the Japan Pharmaceuticals

and Medical Devices Agency (PMDA) for use as a companion diagnostic to select

relapsed and refractory AML patients eligible for quizartinib in Japan.

"Invivoscribe's filing with the FDA for the use of the LeukoStrat CDx FLT3

Mutation Assay as a companion diagnostic for quizartinib is an important

milestone. This submission to the FDA further solidifies the LeukoStrat CDx

FLT3 Mutation Assay as the international benchmark for FLT3 mutation

assessments. We are delighted that our Streamlined CDx(R) program continues to

expand and expedite the global approval of critical oncology treatments," said

Dr. Jeffrey Miller, Invivoscribe's CSO and CEO.

Mutations in the FLT3 gene are among the most important driver mutations in

AML, with approximately one-third of all newly diagnosed adult cases containing

FLT3 mutations. The FLT3 internal tandem duplication (ITD) mutation occurs in

about 25%, and the tyrosine kinase domain (TKD) mutation occurs in

approximately 5% of all newly diagnosed patients with AML.[1]

Invivoscribe's companion diagnostic is an in vitro PCR test which detects both

ITD mutations and 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.

LeukoStrat CDx FLT3 Mutation Assay kits are currently distributed in Japan, the

United States, Europe and China. The LeukoStrat CDx FLT3 Mutation Assay is also

available in Japan, Germany and the United States as a service through

Invivoscribe's wholly-owned LabPMM(R) subsidiaries.  Greater than 95% of

patient samples tested using the FDA-approved LeukoStrat CDx FLT3 Mutation

Assay and a selection of other CLIA-validated PCR-based capillary assays report

out results within 48 hours of sample receipt at any of the LabPMM

laboratories.

About Invivoscribe

Invivoscribe is a global, vertically-integrated biotechnology company dedicated

to Improving Lives with Precision Diagnostics(R). For nearly thirty 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. For additional

information, please contact Invivoscribe at: inquiry@invivoscribe.com or follow

Invivoscribe on Linked In.

[1] Kennedy VE, Smith CC. (2020) Front Oncol. 10:612880.

SOURCE  Invivoscribe Technologies, Inc.

CONTACT: Tony Lialin, tlialin@invivoscribe.com