RELEASE: Invivoscribe Files sPMA with the FDA for Use of the LeukoStrat CDx FLT3 Mutation Assay

- Invivoscribe Files sPMA With The FDA For Use Of The LeukoStrat CDx FLT3 Mutation Assay To Select Patients With Newly Diagnosed FLT3-ITD-Positive AML.

RELEASE: Invivoscribe Files sPMA with the FDA for Use of the LeukoStrat CDx FLT3 Mutation Assay

- Invivoscribe Files sPMA With The FDA For Use Of The LeukoStrat CDx FLT3 Mutation Assay To Select Patients With Newly Diagnosed FLT3-ITD-Positive AML

SAN DIEGO, Oct. 24, 2022 /PRNewswire/ -- Invivoscribe is pleased to announce that it has filed a Supplemental Premarket Approval (sPMA) application with the Food and Drug Administration's Center for Devices and Radiological Health (CDRH). US Food and Drug Administration (FDA) for the use of the LeukoStrat® CDx FLT3 Mutation Assay as the companion diagnostic for Daiichi Sankyo's investigational drug quizartinib. The assay is used for the identification of patients with newly diagnosed acute myeloid leukemia (AML) who have the FLT3-ITD mutation.

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 has been 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 an adjunct diagnostic to select patients with refractory and relapsed AML eligible for quizartinib in Japan.

"Invivoscribe's submission to the FDA for use of the LeukoStrat CDx FLT3 Mutation Assay as an add-on diagnostic for quizartinib is an important milestone. This FDA submission further solidifies the LeukoStrat CDx FLT3 Mutation Assay as the international reference for evaluations of FLT3 mutation. We are delighted that our Streamlined CDx® program continues to expand and accelerate the global approval of critical cancer treatments," said Dr. Jeffrey Miller, Chief Strategy Officer and CEO of Invivoscribe.

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 approximately 25%, and the tyrosine kinase domain (TKD) mutation occurs in approximately 5% of all newly diagnosed AML patients.1

The Invivoscribe Companion Diagnostic is an in vitro PCR test that detects both ITD and TKD D835 and I836 mutations in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates from patients diagnosed with AML. This test, which is available worldwide, includes software that interprets data, generates standardized mutant/wild type 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® subsidiaries. More than 95% of patient samples tested with the FDA-cleared LeukoStrat CDx FLT3 Mutation Assay and a selection of other CLIA-validated PCR-based capillary assays report results within 48 hours of sample receipt in any of the LabPMM laboratories.

About Invivoscribe

Invivoscribe is a vertically integrated global biotechnology company dedicated to improving lives with Precision Diagnostics®. For nearly thirty years, Invivoscribe has been improving the quality of healthcare around the world by providing high-quality, standardized reagents, tests, and bioinformatics tools to advance the field of precision medicine. Invivoscribe has a successful history of partnering with global pharmaceutical companies interested in developing and commercializing companion diagnostics, and offers laboratory and regulatory services expertise. Providing distributable kits as well as clinical trial services through its globally located clinical laboratory subsidiaries (LabPMM), Invivoscribe is an ideal partner from diagnostic development, through clinical trials, regulatory filings and commercialization. For additional information, contact Invivoscribe at: research@invivoscribe.com or follow Invivoscribe on Linked In.

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

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