Invivoscribe is happy to announce that its wholly owned subsidiary, the Laboratory for Personalized Molecular Medicine® (LabPMM) has received approval from New York State (NYS) for the NPM1 MRD Assay. This approval comes just two months after gaining NYS approval for our FLT3 ITD MRD Assay. Together these tests represent a critical tool for patients with acute myeloid leukemia (AML), clinicians and pharmaceutical companies. This new approval underscores Invivoscribe's ongoing commitment to providing the most accurate, standardized measurable residual disease (MRD) testing solutions worldwide.
The NPM1 MRD Assay is a pivotal development in the fight against AML, offering an ultra-sensitive DNA sequencing method to accurately measure trace levels of residual leukemia cells in patients with the NPM1 mutation variants. NPM1 mutations are considered an ideal target for MRD assessment because they are present in ~30% of adult AML cases,1 stable over time,2 and, if present in blood at allele fractions ≥0.01%, are associated with increased relapse and worse overall survival.3 Recent studies show emerging evidence that pre-transplant MRD testing for NPM1 and FLT3-ITD identifies AML patients in remission who are most likely to relapse or experience poor survival.3,4,5
With this approval, LabPMM is helping to transform the landscape of AML research, treatment and drug development. By using MRD as a surrogate endpoint in clinical trials, instead of relying solely on overall survival (OS), pharmaceutical companies can accelerate their drug development timelines. This is particularly valuable in acute disease, where time is of the essence, and earlier intervention can dramatically improve patient outcomes.
"We are proud to receive New York State approval for our NPM1 MRD Assay by NGS, marking our second assay approved by New York State this year," said Jordan Thornes, V.P., Global Clinical Laboratory Operations at LabPMM. "This milestone reflects our continued dedication to advancing precision diagnostics in cancer care. With this latest approval, we're further empowering clinicians with sensitive, reliable tools to detect residual disease and guide treatment decisions with confidence."
LabPMM's NPM1 and FLT3 ITD MRD Assays are standardized next generation sequencing (NGS) tests that complement the LeukoStrat® CDx FLT3 Mutation Assay, which is used to guide treatment selection for patients with AML. These services are offered in the U.S., European Union, and across Asia to ensure patients around the world have access to high-quality, standardized testing and to support the development of cutting-edge cancer treatments. LabPMM remains committed to advancing precision medicine and improving outcomes for patients worldwide.
