KUALA LUMPUR, May 15 (Bernama) -- Invivoscribe Technologies Inc has submitted a study evaluating gilteritinib for the treatment of FLT3 mutation-positive (FLT3mut+) relapsed or refractory acute myeloid leukemia (AML) in adult patients.
A pre-market approval application (Shonin) has been submitted to Japan´s Pharmaceutical and Medical Devices Agency (PMDA) for the LeukoStrat CDx FLT3 Mutation Assay, a statement said.
Invivoscribe also submitted a panel track supplement to the US Food and Drug Administration (FDA) to update the FDA-approved LeukoStrat CDx FLT3 Mutation Assay´s Intended use, specific for gilteritinib.
"These submissions in Japan and the US represent a significant step in our ongoing efforts to harmonize molecular diagnostic testing for what is one of the most important driver mutations in AML in support of precision medicine," said chief scientific officer & chief executive officer of Invivoscribe, Jeffrey Miller.
Invivoscribe, the first company to receive FDA approval for an AML companion diagnostic has collaborated with Astellas Pharma Inc to develop a companion diagnostic to aid in identifying these FLT3mut+ AML patients.
Invivoscribe Technologies Inc is a biotechnology company providing high quality, standardized reagents, tests and bioinformatics tools to advance the fields of personalized molecular diagnostics and personalized molecular medicine. More information at www.invivoscribe.com.
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