Shanghai, May 14, 2024 – We are excited to announce that our cutting-edge product, ColonAiQ® – a targeted gene methylation combined detection reagent kit using the PCR-fluorescence probe method, has received official approval from the Chinese National Medical Products Administration (NMPA). This approval, resulting in a Class III medical device registration certificate, represents a monumental achievement in the early detection and diagnosis of colorectal cancer.
ColonAiQ® is the fruit of extensive research and innovation conducted by our dedicated R&D team. It signifies a significant leap forward in oncology by offering a non-invasive, highly sensitive, and specific approach for the early detection of colorectal cancer through methylation changes in specific genes. The NMPA certification reaffirms ColonAiQ®’s reliability, safety, and clinical relevance, establishing a new benchmark in cancer diagnostics.
Qiang Liu, COO of Singlera Genomics, expressed his enthusiasm, stating, “This accomplishment is a source of great pride for us and holds the potential to alter the lives of millions globally. The key to combating colorectal cancer lies in early detection, and ColonAiQ® brings us closer to making comprehensive, early screening a feasible goal. This certification not only recognizes our team’s unwavering commitment and perseverance but also marks a significant step in our continued dedication to enhancing personalized medicine and patient care.”
The NMPA’s approval of ColonAiQ® marks a crucial milestone for Singlera Genomics and the future of colorectal cancer screening. By offering a non-invasive and precise testing option, Singlera aims to promote earlier and more frequent screenings, ultimately aiming to save lives through timely detection and treatment.
