China NMPA Approves Promega MSI Detection Kit as Companion Diagnostic for KEYTRUDA®
3.2.2026 13:00:00 CET | Business Wire | Press release
The National Medical Products Administration (NMPA) has approved the OncoMate® Microsatellite Instability (MSI) Detection Kit as a Class III in vitro diagnostic medical device in China. It is intended for use as a companion diagnostic to identify MSI-High (MSI-H) solid tumor patients for treatment with KEYTRUDA® (pembrolizumab), Merck & Co., Inc., Rahway, NJ, USA’s anti-PD-1 therapy. This is the first Promega companion diagnostic to receive NMPA approval.
“This approval represents a step toward more personalized and effective cancer treatment in China,” says Alok Sharma, Global Clinical Market Director at Promega. “We are proud to collaborate with pharmaceutical companies to deliver global solutions that expand access to innovative technologies and life-saving, effective therapies.”
China continues to face one of the world’s highest cancer burdens, with solid tumors representing the vast majority of diagnoses nationwide. Despite advances in oncology care, most patients with advanced solid tumors ultimately progress after first-line therapy, creating a critical need for tools that can guide more effective alternative treatment strategies. The OncoMate® MSI Detection Kit is a PCR-based assay designed to evaluate MSI status in tumor tissue. MSI status can be used to guide treatment decisions and support precision oncology strategies in solid tumors.
The approval was supported through a collaboration with Merck & Co., Inc., Rahway, NJ, USA, which markets KEYTRUDA. The collaboration reflects a shared commitment to improving access to diagnostics that guide therapeutic decision-making.
Promega MSI technology has received additional regulatory approvals in China, the European Union and the United States. OncoMate® MSI Dx Analysis System was recently approved by the FDA as a companion diagnostic designed to identify patients with microsatellite stable (MSS) endometrial carcinoma who may benefit from treatment with KEYTRUDA plus LENVIMA® (Lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai.
OncoMate® MSI Detection Kit will soon be available for purchase in China.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Learn more about Promega MSI technology here.
About Promega Corporation
Promega Corporation is a leader in providing innovative solutions and technical support to the life sciences industry. The company’s portfolio of over 4,000 products supports a range of life science work across areas such as cell biology; DNA, RNA and protein analysis; drug development; human identification and molecular diagnostics. These tools and technologies have grown in their application over the last 45 years and are used today by scientists and technicians in labs for academic and government research, forensics, pharmaceuticals, clinical diagnostics and veterinary, agricultural and environmental testing. Promega is headquartered in Madison, WI, USA with branches in 16 countries and over 50 global distributors. Learn more at promega.com.
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