LabPMM Launches Global KMT2A MRD Testing Service to Support Precision Monitoring and Clinical Development in Acute Leukemia
LabPMM®, a global reference laboratory and subsidiary of Invivoscribe®, has announced the worldwide availability of its new KMT2A measurable residual disease (MRD) testing service, expanding its portfolio of advanced molecular diagnostics for hematologic malignancies. The newly introduced service is designed to provide highly sensitive molecular monitoring for patients with acute leukemias carrying KMT2A rearrangements, while also supporting clinical research and the development of next-generation targeted therapies.
The new testing service is now accessible to healthcare providers, academic researchers, and biopharmaceutical companies through LabPMM’s international laboratory network. In the United States, testing is performed in laboratories accredited by the College of American Pathologists (CAP) and certified under the Clinical Laboratory Improvement Amendments (CLIA), ensuring compliance with rigorous quality and regulatory standards.
The launch comes at a time when precision medicine is rapidly transforming leukemia treatment. With the emergence of targeted therapies such as menin inhibitors, clinicians and drug developers increasingly require highly sensitive diagnostic tools capable of accurately detecting measurable residual disease, evaluating treatment response, and monitoring patients for relapse over extended periods.
Addressing an Important Need in Acute Leukemia
Acute leukemias remain among the most aggressive forms of blood cancer, requiring rapid diagnosis and intensive treatment. Despite advances in chemotherapy, stem cell transplantation, and targeted therapies, many patients continue to experience disease recurrence due to residual cancer cells that remain undetectable using conventional diagnostic techniques.
Measurable residual disease (MRD), previously referred to as minimal residual disease, has become one of the most important biomarkers for evaluating treatment effectiveness in leukemia. MRD testing enables physicians to identify extremely small numbers of remaining leukemia cells after treatment—often long before clinical symptoms or standard laboratory tests indicate disease recurrence.
Detecting these residual malignant cells allows clinicians to assess the depth of remission, identify patients at increased risk of relapse, and make more informed treatment decisions regarding consolidation therapy, transplantation, or targeted therapeutic interventions.
LabPMM’s newly launched KMT2A MRD testing service has been developed specifically to address this growing clinical need by providing highly sensitive and standardized molecular monitoring for patients with KMT2A-rearranged leukemias.
Understanding KMT2A Rearrangements
The KMT2A gene, formerly known as MLL (Mixed Lineage Leukemia), plays an essential role in regulating normal blood cell development. However, chromosomal rearrangements involving KMT2A can produce abnormal fusion genes that drive the uncontrolled growth of leukemia cells.
These KMT2A rearrangements (KMT2Ar) are recognized as major oncogenic drivers in both acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL).
Although relatively uncommon across the overall leukemia population, KMT2A rearrangements are particularly significant because they are associated with aggressive disease biology and poor clinical outcomes.
Approximately 80 percent of infant leukemia cases harbor KMT2A rearrangements, making them one of the defining molecular abnormalities in pediatric leukemia. They are also identified in roughly 5 to 15 percent of childhood and adult AML and ALL cases.
Patients with KMT2A-rearranged leukemia often experience reduced sensitivity to conventional chemotherapy, higher relapse rates, and lower long-term survival compared with patients lacking these genetic abnormalities.
Because of these clinical challenges, KMT2A has become an important therapeutic target for drug developers seeking more effective treatment options.
The Rise of Menin Inhibitors
One of the most exciting recent developments in leukemia research has been the emergence of menin inhibitors.
Menin is a protein that interacts closely with KMT2A fusion proteins, helping sustain leukemia cell growth. By disrupting this interaction, menin inhibitors interfere with critical signaling pathways that leukemia cells rely upon for survival and proliferation.
The therapeutic promise of this approach has attracted significant interest from biotechnology and pharmaceutical companies developing targeted therapies for AML and ALL.
Momentum increased substantially following the U.S. Food and Drug Administration’s first approval of a menin inhibitor for patients with relapsed or refractory acute leukemia carrying KMT2A translocations. That approval provided important clinical validation for the drug class and accelerated additional research programs worldwide.
Today, multiple pharmaceutical companies are evaluating menin inhibitors in earlier treatment settings, combination regimens, and frontline therapy.
As these clinical programs expand, reliable molecular diagnostics capable of identifying KMT2A rearrangements and monitoring treatment response have become increasingly important.
Supporting Precision Medicine Through Advanced MRD Testing
LabPMM’s new KMT2A MRD testing service has been designed specifically to meet the evolving requirements of precision oncology and targeted drug development.
The assay targets the most frequently occurring KMT2A partner fusion genes observed in AML and ALL, allowing physicians and researchers to accurately identify molecular abnormalities central to many current menin inhibitor clinical development programs.
Unlike conventional testing methods that primarily determine whether leukemia is present, the new assay provides quantitative molecular measurements.
Results are reported as the percentage of KMT2A rearrangements relative to a standardized housekeeping gene, allowing physicians to precisely monitor changes in disease burden over time.
This quantitative approach enables clinicians to evaluate whether treatment is effectively reducing leukemia cells while also detecting subtle molecular changes that may indicate disease recurrence before clinical relapse occurs.
Exceptional Analytical Sensitivity
One of the most significant strengths of the new testing service is its analytical sensitivity.
The assay utilizes advanced digital polymerase chain reaction (digital PCR or dPCR) technology capable of detecting measurable residual disease at levels as low as 0.005 percent.
This extremely high level of sensitivity allows clinicians to identify tiny populations of residual leukemia cells that may remain after therapy.
Compared with less sensitive diagnostic methods, digital PCR provides greater precision when monitoring deep molecular responses, making it particularly valuable during maintenance therapy and long-term patient follow-up.
Equally important, LabPMM reports turnaround times of as little as 48 hours, enabling physicians to receive actionable molecular information quickly enough to support timely treatment decisions.
Rapid reporting can be especially valuable for patients with aggressive leukemias where clinical management often depends on fast access to accurate laboratory results.
Expanding Invivoscribe’s Comprehensive Myeloid Testing Portfolio
The introduction of KMT2A MRD testing further strengthens Invivoscribe’s growing portfolio of standardized molecular diagnostic solutions for hematologic malignancies.
The company’s integrated testing ecosystem already includes assays and laboratory services supporting detection and measurable residual disease monitoring for several clinically important biomarkers.
These include FLT3 mutation testing, NPM1 mutation analysis, KMT2A rearrangement detection, and AML MRD assessment using multiparametric flow cytometry.
Together, these complementary technologies provide clinicians and pharmaceutical developers with comprehensive molecular monitoring capabilities spanning diagnosis, treatment selection, response assessment, and long-term disease surveillance.
Rather than relying on isolated laboratory tests, healthcare providers can utilize a coordinated diagnostic platform capable of delivering consistent molecular data throughout the patient’s treatment journey.
Enabling Global Clinical Trials
Beyond patient care, standardized MRD testing plays an increasingly important role in clinical research and pharmaceutical development.
As new targeted therapies move through clinical trials, investigators require highly reproducible laboratory data that remain consistent across multiple hospitals, research centers, and countries.
Variability between laboratories has historically complicated interpretation of MRD data, making standardization an important priority for regulatory agencies and drug developers.
LabPMM addresses this challenge through its globally harmonized laboratory network, allowing sponsors to generate standardized molecular data regardless of geographic location.
Such consistency becomes especially valuable in multinational clinical trials evaluating innovative therapies such as menin inhibitors.
Reliable MRD measurements can help investigators determine whether treatments produce meaningful molecular responses, evaluate the durability of those responses, and identify patient populations most likely to benefit from specific therapies.
Supporting Drug Development from Discovery to Commercialization
Invivoscribe and LabPMM emphasize that their integrated capabilities extend well beyond laboratory testing.
Together, the organizations provide pharmaceutical companies with comprehensive support that includes standardized molecular diagnostics, regulatory expertise, companion diagnostic development, and global laboratory services.
Highly sensitive MRD testing increasingly serves several important roles throughout drug development.
These include measuring treatment response depth, evaluating long-term remission, supporting patient stratification strategies, and potentially serving as surrogate clinical endpoints in clinical trials.
The ability to generate robust molecular data earlier during clinical development can help sponsors make better-informed decisions regarding dose selection, patient enrollment, trial expansion, and regulatory planning.
As regulators continue recognizing molecular biomarkers as important indicators of treatment benefit, standardized MRD testing may also contribute to more efficient clinical development pathways for innovative oncology therapies.
Leadership Perspective
Jeff Miller, Chief Executive Officer and Chief Scientific Officer of Invivoscribe, highlighted the growing importance of molecular diagnostics in the era of targeted leukemia treatments.
He noted that the emergence of menin inhibitors is creating significant new therapeutic opportunities for patients with KMT2A-rearranged leukemia. However, realizing the full potential of these therapies requires highly sensitive, standardized molecular testing capable of generating reliable clinical data across global development programs.
According to Miller, expanding LabPMM’s testing portfolio with KMT2A MRD analysis enables clinicians and pharmaceutical partners to identify meaningful treatment responses earlier, monitor response durability more accurately, and ultimately improve patient outcomes through better-informed clinical decisions.
Advancing Precision Oncology
The launch of LabPMM’s global KMT2A MRD testing service represents another important advancement in precision oncology and molecular diagnostics for acute leukemia. By combining highly sensitive digital PCR technology with standardized global laboratory operations, the service provides clinicians, researchers, and biopharmaceutical companies with a powerful tool for monitoring disease burden and evaluating treatment effectiveness.
As targeted therapies such as menin inhibitors continue reshaping the treatment landscape for AML and ALL, accurate molecular monitoring will become increasingly essential for guiding patient care, supporting clinical research, and accelerating drug development. Through its expanding portfolio of molecular diagnostics, Invivoscribe and LabPMM are helping advance precision medicine by delivering reliable, standardized testing solutions that support better clinical decision-making and contribute to the development of innovative therapies for patients with challenging hematologic cancers.
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.