Invivoscribe Launches Test to Accelerate Next-Gen Leukemia Drug Development

SAN DIEGO, CA – August 04, 2026 – In a significant move to advance the treatment of aggressive leukemias, Invivoscribe subsidiary LabPMM has launched a globally available testing service designed to precisely track a high-risk form of the disease. The new KMT2A measurable residual disease (MRD) test leverages highly sensitive digital PCR technology, providing a critical tool for clinicians and pharmaceutical companies developing a promising new class of drugs known as menin inhibitors.

The launch addresses a pressing need for more accurate molecular monitoring in acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL), particularly for patients with rearrangements in the KMT2A gene. These genetic alterations are notorious for driving chemotherapy resistance and high relapse rates, making them one of the most challenging targets in hematologic oncology. By offering a standardized, ultra-sensitive method to detect minute traces of cancer cells, LabPMM aims to transform both patient care and the drug development pipeline.

The Clinical Urgency for a Better Test

KMT2A-rearranged (KMT2Ar) leukemias represent a formidable clinical challenge. While accounting for about 5-15% of childhood and adult acute leukemias, their prevalence skyrockets to nearly 80% of cases in infants, where they are associated with a particularly grim prognosis. Historically, patients with these leukemias face poor outcomes due to the cancer's aggressive nature and its resistance to standard chemotherapy regimens. Relapse is common and often rapid, highlighting the inadequacy of conventional monitoring methods.

For decades, clinicians have relied on methods like cytogenetics and fluorescence in situ hybridization (FISH) to identify KMT2Ar. However, these techniques can miss cryptic or complex rearrangements, potentially leading to misdiagnosis and suboptimal treatment strategies. The ultimate goal after initial treatment is to achieve a state of deep remission, defined by the absence of measurable residual disease (MRD)—the small number of cancer cells that can remain after therapy and lead to a relapse. Achieving MRD negativity is one of the strongest predictors of long-term survival.

This is where LabPMM's new service enters the picture. The test provides a quantitative result with sensitivity down to 0.005%, a level of precision that can detect disease persistence far below the threshold of many conventional methods. This capability is crucial for KMT2Ar leukemias, where even a tiny number of residual cells can rapidly repopulate and cause a full-blown relapse. With a potential turnaround time as fast as 48 hours for results, clinicians can make more timely and informed decisions, such as escalating therapy for patients with persistent MRD or confirming deep responses that may allow for de-escalation, sparing patients from unnecessary toxicity.

Fueling the Next Wave of Leukemia Therapies

The timing of this launch is strategically aligned with a paradigm shift in leukemia treatment: the rise of menin inhibitors. These targeted therapies work by disrupting a critical interaction between the menin protein and the KMT2A fusion protein, effectively switching off the oncogenic engine that drives the leukemia. The recent FDA approval of the first menin inhibitor, revumenib, for relapsed or refractory KMT2A-rearranged acute leukemia has validated this approach and ignited a wave of clinical development.

As pharmaceutical companies advance their menin inhibitor programs into frontline and combination studies, the need for a reliable, standardized biomarker test has become paramount. LabPMM's KMT2A MRD service is purpose-built to meet this demand. By targeting the most common KMT2A partner fusion genes, the assay directly aligns with the biology central to these new drugs.

“Menin inhibitors are creating important new possibilities for patients with KMT2A-rearranged leukemia, but continued development requires a partner that can deliver highly sensitive, standardized molecular data across clinical programs and geographies,” said Jeff Miller, CEO and CSO of Invivoscribe. “By making KMT2A MRD testing available through LabPMM, we are helping clinicians and biopharmaceutical partners measure meaningful responses earlier, monitor their durability, and ultimately improve patient care.”

This synergy between advanced diagnostics and targeted therapy is a cornerstone of modern drug development. A highly sensitive MRD test allows drug developers to stratify patients for clinical trials, ensuring the right patients receive the investigational drug. It provides an early and accurate readout of drug efficacy, allowing for quicker go/no-go decisions. Furthermore, tracking the depth and durability of molecular response with a tool like LabPMM's test can provide the robust data needed to support regulatory submissions, potentially using MRD as a surrogate endpoint to accelerate the approval process and bring life-saving drugs to patients faster.

Setting a Global Standard in Precision Diagnostics

The launch is more than just a new test; it represents Invivoscribe's broader strategy to create an integrated, global ecosystem for precision diagnostics. By making the KMT2A MRD service available through its worldwide network of CAP/CLIA-accredited laboratories in the U.S., Germany, Japan, and China, the company is tackling a major hurdle in global clinical trials: data variability. A standardized test that generates consistent, high-quality molecular data across continents ensures that results from a trial site in Europe are directly comparable to those from a site in North America or Asia.

This standardization reduces development risk for biopharmaceutical sponsors, who can make more confident, data-driven decisions throughout the clinical trial process. The technological foundation of the service—digital PCR—is key to this consistency, offering absolute quantification of cancer-related gene fusions with exceptional accuracy and reproducibility.

This new offering expands Invivoscribe’s comprehensive myeloid testing portfolio, which already includes globally standardized assays for other critical leukemia biomarkers like FLT3 and NPM1, as well as AML MRD assessment by multiparametric flow cytometry. This positions the company as a one-stop-shop partner for hematologic oncology drug development, offering a vertically integrated suite of services from diagnostic development and clinical trial testing to regulatory expertise and commercialization of companion diagnostics. By providing the critical tools to measure what matters, Invivoscribe is not only enabling better patient care today but also paving the way for the next generation of precision cancer medicines.