AsiaNet 84075

SAN DIEGO, May 19, 2020 /PRNewswire=KYODO JBN/ --

Invivoscribe to offer the LeukoStrat(R) CDx FLT3 Mutation Assay as an FDA

approved kit with analysis software.

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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.

SOURCE: Invivoscribe, Inc.