Invivoscribe is pleased to announce that the NPM1 MRD Assay developed by its wholly owned subsidiary, the Laboratory for Personalized Molecular Medicine ® (LabPMM), has been approved by the State of New York. This approval comes just two months after the FLT3 ITD MRD Assay was approved by the State of New York. Both tests will provide critical tools for acute myeloid leukemia (AML) patients, clinicians, and pharmaceutical companies. This approval further demonstrates Invivoscribe’s commitment to providing highly accurate, standardized minimal residual disease (MRD) testing solutions worldwide.
The NPM1 MRD test is a major breakthrough in the diagnosis and treatment of AML. It uses ultrasensitive DNA sequencing technology to accurately detect trace amounts of residual leukemia cells in patients with NPM1 gene mutations. NPM1 mutations are considered an ideal target for MRD assessment because they are present in approximately 30% of adult AML cases1 and tend to stabilize over time2 . If the allele ratio in the blood is ≥ 0.01%, it is associated with increased relapse rate and reduced overall survival3 . Recent studies have shown that pre-transplant MRD testing for NPM1 and FLT3 -ITD can identify patients with remitted AML who are most likely to relapse or have poor survival3,4,5 .
With this approval, LabPMM will reshape the landscape of AML research, treatment, and drug development. Pharmaceutical companies can significantly accelerate the development of new drugs by using MRD as an alternative endpoint for clinical trials (rather than relying solely on overall survival [OS]). This is especially important for acute leukemias with a very short treatment window, and early intervention can significantly improve patient prognosis.
“We are proud to announce the approval of our NGS-based NPM1 MRD test in New York State, our second approval this year,” said Jordan Thornes, Vice President of Global Clinical Laboratory Operations at LabPMM. “This milestone reflects our continued commitment to advancing precision cancer diagnostics. This newly approved test will provide clinicians with a highly sensitive and reliable tool to help detect residual disease and guide precise treatment decisions.”
LabPMM’s NPM1 and FLT3 ITD MRD assays, both using standardized next-generation sequencing (NGS) technology, complement the LeukoStrat ® CDx FLT3 mutation assay used to guide treatment selection for AML patients. These services are available in the U.S., EU, and Asia, ensuring high-quality, standardized testing for patients around the world and supporting the development of cutting-edge cancer therapies. LabPMM remains committed to advancing precision medicine and improving outcomes for patients around the world. To learn more about the NPM1 MRD assay and LabPMM’s full testing program, visit https://invivoscribe.com/clinical-lab-services/ or contact us at inquiry@invivoscribe.com and follow us on LinkedIn.
About Invivoscribe
Invivoscribe ® is a vertically integrated global biotechnology company dedicated to Improving Lives with Precision Diagnostics ® . For nearly three decades, Invivoscribe has advanced precision medicine by providing high-quality standardized reagents, assays, and bioinformatics tools, thereby improving the quality of healthcare worldwide. Invivoscribe has an outstanding track record of success in partnering with pharmaceutical companies for clinical trial testing through its global network of laboratories in the United States, Germany, Japan, and China. The company has also achieved a strong track record in the development and commercialization of companion diagnostics, which is supported by its deep expertise in both regulatory affairs and laboratory services. Providing distributable test kits and clinical trial services through its global clinical laboratory subsidiary (LabPMM ® ), Invivoscribe is an ideal partner for the entire process from diagnostic development, clinical trials, regulatory submissions, and commercialization.
