Will OncoMate® MSI Detection Kit ease China’s cancer burden?

Introduction

The National Medical Products Administration (NMPA) is the main regulatory body of China. This regulatory body assesses the safety measures and represents medical devices, cosmetics and drugs. Further, those products continue to be commercialised in their respective vast markets legally. This government division is responsible for safety monitoring, registrations, inspections, licensing and checking standard volume to green light the products.

Announcement

The National Medical Products Administration (NMPA) has greenlighted the OncoMate® Microsatellite Instability (MSI) Detection Kit. The kit will be positioned as a class 3 in vitro diagnostic medical device in its home region (China). This kit might reduce the stress of the cancer population. It’s planned to join the diagnostic line to address the MSI-High (MSI-H) solid tumor patient population to prove the treatment with KEYTRUDA® (pembrolizumab).

The KEYTRUDA® is an anti-PD-1 therapy of Merck & Co., Inc., Rahway, NJ, USA. It’s the first time that NMPA approval was based on how the tools can contribute to the diagnosis throughout.

Good news for China Healthcare

In comparison to any other region, China is under a massive cancer burden, recording an infinite number of solid tumor diagnoses. There have been many upgradations in the oncology sector, be it patient care or drug development, but the patients don’t show satisfying recovery. Henceforth, the need for tools becomes essential for alternative treatment plans.

To this concern, OncoMate® MSI Detection Kit is the solution as it’s a PCR-related assay engineered to assess MSI activities in tumor tissue. These MSI activities will act as a guide to the major oncology treatment decisions and further contribute to the precision oncology approaches in solid tumors.

This approval was possible due to the partnership with Merck & Co., Inc., Rahway, NJ, USA, who commercialize KEYTRUDA. The partnership stands on the foundation of joint commitment and dedication to enhancing and easing the reach of diagnostics that will support therapeutic decision-making.

Global Clinical Market Director at Promega, Alok Sharma, said, “The approval is a level up for effective and personalised cancer treatment in China. We take pride in partnering with pharmaceutical companies to provide solutions worldwide. The solutions that will extend access to reviving, effective therapies and innovative technologies are a plus point.”

Where Promega MSI technology has already earned multiple regulatory approvals in China, the United States and the European Union, this new kit will also prove its responsibility to contribute to the Chinese Oncology Industry.