Invivoscribe Announces FDA Approval for Distribution of the LeukoStrat CDx FLT3 Mutation Assay as an IVD Kit in the United States

General Press Releases Tuesday May 19, 2020 17:00
SAN DIEGO--19 May--PRNewswire/InfoQuest
Invivoscribe to offer the LeukoStrat(R) CDx FLT3 Mutation Assay as an FDA approved kit with analysis software.

In 2017, Invivoscribe's LeukoStrat(R) CDx FLT3 Mutation Assay became the first FDA approved FLT3 test and launched as a testing service at LabPMM, Invivoscribe's clinical laboratory in San Diego. This PMA supplement approval by the FDA provides customers a choice to purchase the IVD-labeled LeukoStrat(R) CDx FLT3 Mutation Assay kits for in-house testing. The ability to perform efficient, accurate, and objective FLT3 testing at regional laboratories, cancer treatment centers, and hospitals is expected to improve the management of patients diagnosed with acute myelogenous leukemia (AML).

As the companion diagnostic to midostaurin (US, EU, Switzerland, Australia), gilteritinib fumarate (US, JP, EU), and quizartinib hydrochloride (JP), the LeukoStrat CDx is the only globally standardized FLT3 mutation test validated to meet international regulatory standards for detection of genetic mutations in the FLT3 gene, which is one of the most important driver mutations in AML.   The LeukoStrat(R) CDx FLT3 Mutation Assay may be used as an aid in assessment of AML patients for treatment with approved FLT3 targeted therapies.

"The release of the IVD-labeled kit will benefit patients afflicted with AML and is a critical tool for healthcare providers to identify the most appropriate treatment for newly diagnosed or relapsed/refractory FLT3mut+ AML patients," said Jeffrey Miller, Invivoscribe CSO and CEO.

US Intended Use

The LeukoStrat(R) CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detect internal tandem duplication (ITD) 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 (AML).

The LeukoStrat(R) CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with AML for whom RYDAPT(R) (midostaurin) treatment is being considered.
The LeukoStrat(R) CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with AML for whom XOSPATA(R) (gilteritinib) treatment is being considered.
The test is for use on the 3500xL Dx Genetic Analyzer.
About Invivoscribe

Invivoscribe has been Improving Lives with Precision Diagnostics(R) for more than twenty-five years, advancing the field of precision medicine by developing and selling standardized reagents, tests, and bioinformatics tools to more than 700 customers in 160 countries. Invivoscribe also has a significant impact on global health working with pharmaceutical companies to accelerate approvals of new drugs and treatments by supporting international clinical trials, developing, commercializing companion diagnostics, and providing expertise in both regulatory and laboratory services. With its proven ability to provide global access to distributable reagents, kits, and controls, as well as clinical trial services through our international clinical lab subsidiaries (LabPMM), Invivoscribe has demonstrated it is an ideal partner. For additional information please contact Invivoscribe at: customerservice@invivoscribe.com or visit: www.invivoscribe.com.

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