Invivoscribe is pleased to announce that its wholly owned subsidiary, the Laboratory for Personalized Molecular Medicine® (LabPMM), has received New York State (NYS) approval for its NPM1 MRD Assay. This significant milestone comes just two months after obtaining NYS approval for the FLT3 ITD MRD Assay, further expanding LabPMM’s portfolio of cutting-edge diagnostic tools for patients with acute myeloid leukemia (AML), healthcare providers, and pharmaceutical partners. The latest approval reinforces Invivoscribe’s commitment to delivering highly accurate, standardized measurable residual disease (MRD) testing worldwide.
The NPM1 MRD Assay represents a crucial advancement in AML management, utilizing ultra-sensitive next-generation DNA sequencing to detect minimal residual disease in patients carrying NPM1 mutations. These mutations, present in approximately 30% of adult AML cases, are stable over time and serve as a highly specific target for MRD assessment. The presence of NPM1 mutations at allele fractions ≥0.01% has been strongly associated with increased relapse risk and decreased overall survival. Recent studies increasingly support the role of MRD testing for both NPM1 and FLT3-ITD mutations in identifying patients at higher risk of relapse, particularly in the pre-transplant setting.
By enabling precise MRD monitoring, LabPMM’s assays are transforming the clinical research landscape, offering pharmaceutical companies the ability to use MRD as a surrogate endpoint in clinical trials. This approach has the potential to expedite drug development, particularly for aggressive diseases like AML where early intervention can significantly impact patient outcomes.
“We are honored to receive New York State approval for our NPM1 MRD Assay using NGS, marking our second approval this year,” stated Jordan Thornes, Vice President of Global Clinical Laboratory Operations at LabPMM. “This achievement reflects our unwavering dedication to advancing precision diagnostics in oncology. With this latest approval, we continue to provide clinicians with highly sensitive and standardized tools to guide treatment decisions with greater confidence.”
LabPMM’s NPM1 and FLT3 ITD MRD assays complement the widely adopted LeukoStrat® CDx FLT3 Mutation Assay, enhancing treatment selection and disease monitoring for AML patients. These advanced, standardized testing services are now available across the U.S., European Union, and Asia, ensuring global access to high-quality diagnostics and supporting the development of innovative cancer therapies. LabPMM remains committed to driving precision medicine forward and improving outcomes for patients worldwide.