NEW YORK – Invivoscribe said Tuesday that its subsidiary Laboratory for Personalized Molecular Medicine (LabPMM) has received approval from the New York State Department of Health to offer the FLT3 ITD MRD Assay to assess measurable residual disease to guide treatment for acute myeloid leukemia (AML) patients.
LabPMM's next-generation sequencing assay uses patient blood or bone marrow samples to detect and track internal tandem duplication (ITD) mutations in the fms-like tyrosine kinase 3 (FLT3) gene at an allele sensitivity of 5 x 10-5, Invivoscribe said.
FLT3 ITD mutations are the most prevalent mutations found in AML and are characterized by an aggressive phenotype with a high prevalence of relapse. Detection of residual FLT3 ITD allows clinicians to identify patients that can benefit from continuation or modification of treatment and predict clinical outcomes, Invivoscribe said.
"This milestone reflects our commitment to improve patient lives with precision diagnostics," Jordan Thornes, VP of global clinical operations at LabPMM, said in a statement. "With New York state's approval, we are immediately able to extend access to this important test to clinicians and patients throughout one of the nation's largest and most rigorously regulated laboratory testing markets."