Invivoscribe's LabPMM Gains New York State Approval for the FLT3 ITD MRD Assay
Following a rigorous review by the Clinical Laboratory Evaluation Program (CLEP), the Department of Health has determined that LabPMM meets the required standards and granted approval to offer the FLT3 ITD MRD Assay in New York State. This approval underscores the assay's robust analytical performance and clinical utility in the detection of MRD in patients with FLT3 ITD-mutated AML.
"This milestone reflects our commitment to improve patient lives with precision diagnostics," said Jordan Thornes, V.P. Global Clinical Operations at LabPMM ®. "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."
The FLT3 ITD MRD assay is a targeted, highly sensitive next-generation sequencing (NGS) assay that detects and tracks internal tandem duplication (ITD) mutations in the fms-like tyrosine kinase 3 (FLT3) gene at an allele sensitivity of 5 x 10 -5. FLT3 ITD mutations are the most prevalent mutations found in AML and are characterized by an aggressive phenotype with a high prevalence of relapse. 1,2 Detection of residual FLT3 ITD allows clinicians to identify patients that can benefit from continuation or modification of treatment and predict clinical outcomes. 1,2,3
For more information about the FLT3 ITD MRD Assay and LabPMM's full test menu, please visit https://invivoscribe.com/clinical-lab-services/ or contact us at inquiry@invivoscribe.com and follow us on LinkedIn.
About Invivoscribe
Invivoscribe ® is a global, vertically integrated biotechnology company dedicated to Improving Lives with Precision Diagnostics ®. For thirty years, Invivoscribe has improved the quality of healthcare worldwide by providing high quality standardized reagents, tests, and bioinformatics tools to advance the field of precision medicine. Invivoscribe has a successful track record of partnerships with pharmaceutical companies interested in clinical trial testing via our global lab network located in the US, Germany, Japan and China, and in developing and commercializing companion diagnostics, with our rigorous expertise in both regulatory and laboratory services. Providing distributable kits, as well as clinical trial services through its globally located clinical lab subsidiaries (LabPMM ®), Invivoscribe is an ideal partner from diagnostic development, through clinical trials, regulatory submissions, and commercialization.
Dillon, L., et al. JAMA. 2023;329(9):745-755.
Dillon, L., et al. JAMA Oncol. 2024;10(8):1104-1110.
Levis, MJ et al. (2018) Blood Advances. 2: 825-831.
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