LabPMM Launches Global KMT2A Measurable Residual Disease Testing Service to Advance Precision Monitoring in Acute Leukemia
LabPMM®, a subsidiary of Invivoscribe®, has announced the worldwide launch of its new KMT2A measurable residual disease (MRD) testing service, expanding access to highly sensitive molecular monitoring for patients with acute leukemia. The new digital polymerase chain reaction (dPCR)-based testing service is now available through LabPMM’s global laboratory network, including CAP/CLIA-accredited testing services in the United States, providing healthcare providers, clinical researchers, and biopharmaceutical companies with a standardized solution for monitoring disease progression and treatment response in patients with KMT2A-rearranged leukemias.
The launch comes at a pivotal time in hematology and oncology as precision medicine continues to transform the treatment of acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). Advances in targeted therapies, particularly the development of menin inhibitors, have increased the need for highly sensitive molecular diagnostics capable of detecting minimal levels of residual disease after treatment. LabPMM’s new testing service is designed to address this growing clinical demand by providing rapid, standardized, and highly sensitive detection of KMT2A rearrangements, enabling clinicians and researchers to monitor disease burden with greater precision throughout the course of treatment.
Meeting an Emerging Need in Leukemia Care
The introduction of the KMT2A MRD testing service reflects the increasing importance of molecular diagnostics in modern leukemia management. While traditional diagnostic techniques remain essential for identifying leukemia at diagnosis, advances in targeted therapies have created a growing need for more sophisticated tools capable of monitoring extremely small amounts of residual disease that remain after treatment.
Measurable residual disease, often referred to as minimal residual disease, represents the small number of cancer cells that may persist in the body even after patients achieve clinical remission. Although these remaining cells are often undetectable using conventional microscopic examination, they can eventually lead to disease relapse if not identified and managed appropriately.
Highly sensitive MRD testing has therefore become an increasingly valuable component of leukemia care, helping physicians evaluate treatment effectiveness, estimate relapse risk, and make more informed therapeutic decisions.
LabPMM’s newly introduced service is specifically designed to support these objectives while providing globally standardized molecular testing across international clinical programs.
Understanding KMT2A Rearrangements
The new assay focuses on detecting KMT2A rearrangements (KMT2Ar), important genetic abnormalities that play a major role in several forms of acute leukemia.
The KMT2A gene, previously known as MLL (Mixed Lineage Leukemia), regulates gene expression involved in normal blood cell development. When chromosomal rearrangements disrupt this gene, abnormal fusion proteins are created that drive leukemia formation.
These genetic alterations are recognized as powerful oncogenic drivers in both acute myeloid leukemia and acute lymphoblastic leukemia.
KMT2A rearrangements occur with particularly high frequency in infant leukemia, where they are present in approximately 80 percent of cases.
Although less common in older patients, they are still identified in approximately 5 to 15 percent of childhood and adult leukemia cases.
Patients whose leukemia carries KMT2A rearrangements often experience more aggressive disease characterized by resistance to conventional chemotherapy, increased risk of relapse, and generally poorer long-term outcomes compared with many other leukemia subtypes.
Because of these clinical challenges, KMT2A has become an important target for both molecular diagnostics and therapeutic innovation.
The Growing Role of Menin Inhibitors
Recent advances in targeted therapy have dramatically changed the treatment landscape for patients with KMT2A-rearranged leukemia.
One of the most promising developments has been the emergence of menin inhibitors, a new class of targeted medicines designed to interfere with the interaction between menin proteins and KMT2A fusion proteins.
Disrupting this interaction may slow or halt leukemia cell growth while allowing normal blood cell development to resume.
The therapeutic potential of this approach received important validation following the first U.S. Food and Drug Administration approval of a menin inhibitor for patients with relapsed or refractory acute leukemia carrying KMT2A translocations.
Since that approval, multiple pharmaceutical companies have expanded development programs investigating menin inhibitors across earlier stages of treatment, combination regimens, and additional patient populations, including those with NPM1-mutated leukemia.
As these clinical programs continue to evolve, the need for standardized molecular monitoring has become increasingly important.
Researchers require reliable diagnostic tools capable of accurately measuring treatment response while detecting even extremely low levels of remaining leukemia cells.
Supporting Precision Medicine
The introduction of LabPMM’s KMT2A MRD testing service is intended to support precision medicine approaches throughout clinical development and routine patient care.
Unlike conventional laboratory techniques that primarily establish diagnosis, MRD testing enables ongoing monitoring of disease burden during and after treatment.
This information can help physicians evaluate whether therapies are successfully eliminating leukemia cells, determine the depth of molecular response achieved, and monitor patients for early signs of disease recurrence.
Such insights have become particularly valuable as targeted therapies produce increasingly deep remissions that require highly sensitive testing technologies to evaluate.
Highly Sensitive Digital PCR Technology
The new service utilizes advanced digital polymerase chain reaction (dPCR) technology, one of the most sensitive molecular diagnostic methods currently available for detecting rare genetic abnormalities.
Digital PCR works by partitioning biological samples into thousands of individual reactions before amplification, allowing extremely precise quantification of target genetic sequences.
Compared with traditional PCR methods, digital PCR offers enhanced sensitivity, improved reproducibility, and highly accurate measurement of low-abundance genetic alterations.
According to LabPMM, the new assay achieves a detection sensitivity of 0.005 percent, enabling identification of exceptionally small amounts of residual leukemia.
This level of analytical performance allows clinicians to detect molecular disease long before it becomes clinically apparent through conventional diagnostic methods.
Rapid Results for Clinical Decision-Making
In addition to its high analytical sensitivity, the testing service is designed to provide rapid turnaround times.
LabPMM reports that results can be delivered in as little as 48 hours, allowing physicians and researchers to receive timely molecular information that may influence treatment decisions.
Rapid reporting is particularly important during active clinical management, where treatment adjustments often depend upon current disease status.
The assay produces quantitative results expressed as the percentage of KMT2A rearrangements relative to a housekeeping gene, providing standardized measurements suitable for longitudinal monitoring across multiple testing time points.
Such quantitative reporting facilitates consistent assessment of treatment response throughout the course of therapy.
Comprehensive Coverage of Common Fusion Partners
The assay has been developed to detect the most common KMT2A partner fusion genes observed in patients with AML and ALL.
By targeting these clinically significant rearrangements, the testing platform aligns closely with the molecular biology underlying many current menin inhibitor clinical development programs.
This broad coverage enhances the utility of the assay for both clinical care and pharmaceutical research, allowing consistent evaluation across diverse patient populations.
Expanding Invivoscribe’s Myeloid Testing Portfolio
The launch of the KMT2A MRD service further strengthens Invivoscribe’s growing portfolio of molecular diagnostics for hematologic malignancies.
The company’s existing offerings already include globally standardized molecular assays and laboratory services supporting both diagnostic screening and MRD monitoring for several important leukemia biomarkers.
These include testing for FLT3 mutations, NPM1 mutations, and KMT2A rearrangements, as well as measurable residual disease assessment using multiparametric flow cytometry.
By combining molecular diagnostics with advanced laboratory services, Invivoscribe and LabPMM provide integrated testing solutions covering multiple stages of leukemia diagnosis, treatment monitoring, and clinical research.
Supporting Global Drug Development
Beyond routine clinical care, the new testing service is expected to play an increasingly important role in global pharmaceutical development.
As targeted therapies become more precise, clinical trials increasingly rely upon molecular biomarkers to evaluate treatment effectiveness.
Highly sensitive MRD testing enables researchers to measure the depth of molecular response, assess durability of remission, and potentially use MRD status as a surrogate endpoint for evaluating investigational therapies.
Standardized testing across international study sites is particularly important for multinational clinical trials, ensuring consistent laboratory methodologies regardless of geographic location.
This harmonization improves data quality while facilitating regulatory review across multiple healthcare systems.
Integrated Companion Diagnostic Expertise
Invivoscribe and LabPMM also provide expertise extending beyond laboratory testing.
Their integrated ecosystem includes regulatory support, companion diagnostic development, and standardized global laboratory operations designed to support pharmaceutical sponsors from early clinical research through commercialization.
Companion diagnostics have become increasingly important in precision oncology because they help identify patients most likely to benefit from targeted therapies while supporting regulatory approval strategies.
By combining molecular diagnostics with regulatory expertise, the organizations aim to reduce development risk while accelerating access to innovative treatments.
Leadership Highlights Clinical Impact
Jeff Miller, Chief Executive Officer and Chief Scientific Officer of Invivoscribe, emphasized that the rapid advancement of menin inhibitors has created important new treatment opportunities for patients with KMT2A-rearranged leukemia.
He noted, however, that successful clinical development requires highly sensitive and standardized molecular testing capable of generating consistent data across international studies.
According to Miller, making KMT2A MRD testing available through LabPMM’s global laboratory network enables healthcare providers and biopharmaceutical partners to detect meaningful treatment responses earlier, monitor their durability over time, and ultimately improve patient care through more informed clinical decision-making.
Advancing Precision Oncology Through Standardized Molecular Testing
The global launch of LabPMM’s KMT2A measurable residual disease testing service represents another important advancement in precision diagnostics for acute leukemia. As targeted therapies such as menin inhibitors continue reshaping the treatment landscape, highly sensitive molecular monitoring has become increasingly essential for evaluating treatment response, detecting early relapse, and guiding personalized patient care.
By combining advanced digital PCR technology, rapid turnaround times, global laboratory standardization, and integrated regulatory expertise, LabPMM and Invivoscribe are expanding the tools available to clinicians, researchers, and pharmaceutical developers working to improve outcomes for patients with AML and ALL. The new service strengthens the organizations’ comprehensive hematology testing portfolio while supporting the continued evolution of precision medicine in leukemia through accurate, standardized, and clinically actionable molecular diagnostics.
About Invivoscribe
Invivoscribe® is a global, vertically integrated biotechnology company dedicated to Improving Lives with Precision Diagnostics®. For over 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 U.S., Germany, Japan, and China, and in developing and commercializing companion diagnostics, with 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.