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InVivoScribe Gets European OK for Leukemia Mutation Assay

NEW YORK (GenomeWeb News) – InVivoScribe Technologies has received the CE IVD Mark for its LeukoStrat FLT3 Mutation Assay, the San Diego-based firm said today.

The PCR-based assay detects internal tandem duplications and point mutations in the FLT3 gene from whole blood or bone marrow in patients with acute myelogenous leukemia. According to privately held InVivoScribe, the mutation status of the FLT3 receptor gene is the most important prognostic indicator of disease outcome in cytogenically normal AML.

The firm said that the World Health Organization has recommended evaluation of FLT3 mutation status in CN-AML to assist in the clinical management of patients with AML.

"The FLT3 assay is the first of what we expect will be a number of CE marked LeukoStrat assays we will introduce to test key prognostic markers in hematologic malignancies," InVivoScribe CSO and CEO Jeffrey Miller said in a statement.

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