NEW YORK – Invivoscribe announced on Thursday that its LeukoStrat CDx FLT3 Mutation Assay for patients with acute myelogenous leukemia has been approved under Europe's In Vitro Diagnostic Regulations.
The PCR-based test detects internal tandem duplications and tyrosine kinase domain mutations D835 and I836 in the FLT3 gene in DNA from patients with acute myelogenous leukemia, the San Diego-based company said in a statement.
The test was approved by notified body BSI and the European Medicines Agency as a Class C assay, Jason Gerhold, the firm's global director of regulatory, quality, and clinical affairs, said in a statement. Class C is the second-highest risk category for IVDs under the IVDR system.
Last year, the firm filed a supplemental premarket approval submission with the US Food and Drug Administration for the use of the assay as a companion diagnostic for Daiichi Sankyo's quizartinib in certain acute myeloid leukemia patients. The test was approved by Japanese regulators for use with the drug in 2019.