FDA Approves Promega OncoMate® MSI Dx Analysis System as Companion Diagnostic for KEYTRUDA® Plus LENVIMA® in Advanced Endometrial Carcinoma
The U.S. Food and Drug Administration (FDA) has officially approved the Promega OncoMate® MSI Dx Analysis System as a companion diagnostic to identify patients with microsatellite stable (MSS) endometrial carcinoma who may be eligible for treatment with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with LENVIMA® (lenvatinib), an orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai Co., Ltd.
This marks a significant milestone for Promega Corporation, as it is the company’s first companion diagnostic to receive FDA approval. The authorization represents an important step forward in advancing precision medicine and expanding access to diagnostics that help guide optimal treatment strategies for patients with advanced endometrial cancer.
A Milestone in Precision Oncology
The OncoMate® MSI Dx Analysis System is a polymerase chain reaction (PCR)-based assay designed to determine a tumor’s microsatellite instability (MSI) status, a key genomic biomarker that reflects defects in the DNA mismatch repair system. MSI testing plays a pivotal role in oncology today, helping clinicians identify tumors that are either MSI-high (MSI-H) or microsatellite stable (MSS), which can significantly influence treatment planning.
While MSI-H tumors often respond to certain immunotherapies, such as immune checkpoint inhibitors, MSS tumors typically require a different therapeutic approach. The newly approved OncoMate® MSI Dx companion diagnostic provides clinicians with a reliable and standardized method to distinguish between these tumor types, enabling them to determine whether a patient with advanced endometrial carcinoma may benefit from KEYTRUDA plus LENVIMA combination therapy.
By offering robust, reproducible MSI analysis through a streamlined PCR process, Promega’s OncoMate® system empowers laboratories and oncologists to make data-driven clinical decisions that enhance personalized treatment strategies and improve patient outcomes.
Clinical Relevance of MSI Testing in Endometrial Carcinoma
Endometrial carcinoma, a cancer originating in the lining of the uterus, is one of the most common gynecologic malignancies in the United States and worldwide. While many patients with early-stage disease respond well to surgery and local therapies, those with advanced or recurrent endometrial carcinoma face limited treatment options and often poor prognoses.
Recent advances in immunotherapy have transformed the treatment landscape, particularly for tumors with certain genetic signatures. However, identifying which patients are likely to respond to these therapies requires reliable companion diagnostics that can accurately assess tumor biology.
Microsatellite instability serves as one such biomarker. Tumors with MSI-H exhibit a high mutation rate due to defects in DNA mismatch repair, which can make them more immunogenic and responsive to checkpoint inhibition. Conversely, MSS tumors—those without high instability—tend to rely on other molecular pathways, necessitating different therapeutic combinations.
The KEYTRUDA plus LENVIMA regimen has demonstrated clinical benefit for certain patients with advanced MSS endometrial carcinoma. The FDA’s approval of Promega’s OncoMate® MSI Dx Analysis System as a companion diagnostic provides a crucial tool for identifying these patients, ensuring more precise and effective use of combination immunotherapy.
Industry Collaboration Driving Personalized Medicine
The FDA approval of OncoMate® MSI Dx as a companion diagnostic was achieved through a strategic collaboration between Promega and Merck, which markets KEYTRUDA in partnership with Eisai, the developer of LENVIMA. Together, these organizations share a common mission: to advance personalized medicine and expand access to high-quality diagnostics that enable clinicians to select the most appropriate treatments for individual patients.
“This approval underscores the critical role diagnostics play in accurately matching the right patients, at the right time, with the right therapy,” said Alok Sharma, Global Clinical Market Director at Promega. “We are committed to delivering reliable tools that guide clinical decisions and help improve patient outcomes. The OncoMate® MSI Dx companion diagnostic represents another step forward in our mission to make precision medicine accessible to more patients around the world.”
Through continued collaboration with pharmaceutical leaders, Promega aims to accelerate the integration of diagnostics and therapeutics, an approach often referred to as “theranostics.” Such partnerships exemplify the growing emphasis on co-development, where diagnostic tools are created alongside novel therapeutics to ensure that clinical benefits reach the right populations efficiently.
Expanding a Proven Technology Platform
The OncoMate® MSI Dx Analysis System is built upon Promega’s well-established MSI technology, which has been widely used in both research and clinical laboratories for over two decades. The assay utilizes five monomorphic mononucleotide repeat markers to determine MSI status in tumor tissue, offering a standardized, validated, and highly reproducible method of assessment.
The technology was previously recognized by the FDA when OncoMate® MSI Dx became the first PCR-based molecular diagnostic cleared for identifying colorectal cancer patients who may benefit from additional testing for Lynch syndrome, an inherited condition associated with a high risk of colorectal and other cancers.
The newly expanded indication for endometrial carcinoma extends the utility of the OncoMate® platform, allowing clinicians to leverage a familiar, FDA-approved technology for broader oncology applications.
In addition to U.S. regulatory clearance, Promega MSI technology has also received approvals in China and the European Union, further supporting global harmonization of diagnostic standards in oncology. This international recognition highlights the assay’s reliability, performance consistency, and value in guiding clinical decisions across diverse healthcare systems.
Supporting a Broader Vision for Oncology Care
The FDA’s decision reinforces the importance of companion diagnostics as an integral component of precision oncology. By helping clinicians identify the molecular characteristics of each tumor, companion diagnostics enable the selection of treatments most likely to be effective while minimizing unnecessary exposure to therapies that may not provide benefit.
In the case of advanced endometrial carcinoma, where therapeutic options have historically been limited, the ability to identify MSS tumors that could respond to the KEYTRUDA + LENVIMA combination represents a meaningful advance. The use of a standardized, FDA-approved assay such as OncoMate® MSI Dx enhances diagnostic confidence and facilitates consistent clinical decision-making across institutions.
Promega’s continued investment in molecular diagnostic technologies reflects its broader commitment to advancing cancer care. The company’s growing portfolio of clinical-grade assays, partnerships with leading pharmaceutical firms, and dedication to regulatory excellence position it as a trusted innovator in the evolving landscape of biomarker-driven medicine.
As oncology continues to evolve toward increasingly personalized treatment paradigms, diagnostic innovations like OncoMate® MSI Dx will play an ever more essential role. The integration of molecular diagnostics into standard clinical workflows ensures that therapies such as KEYTRUDA and LENVIMA are administered to patients most likely to derive benefit, improving both clinical outcomes and healthcare efficiency.
The FDA approval of the OncoMate® MSI Dx Analysis System as a companion diagnostic for the KEYTRUDA and LENVIMA combination in advanced endometrial carcinoma marks not only a milestone for Promega but also a broader victory for the precision medicine community. It demonstrates how collaborative science, rigorous validation, and regulatory diligence can converge to deliver real-world impact for patients facing complex cancers.
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