Recently, the National Medical Products Administration (NMPA) announced that Geneseeq’s “EGFR/KRAS/MET Gene Mutation Detection Kit (Reversible Terminator Sequencing Method)” has entered the Special Review and Approval of Innovative Medical Device pathway. This marks the first time such a product has been included in this program in China’s NGS liquid biopsy field.
International oncology guidelines, such as those from NCCN, ESMO and CSCO, recommend the use of liquid biopsy as an alternative when tumor tissue samples are inaccessible. Currently, most approved NGS IVD kits on China’s market are designed for tumor tissue testing. Geneseeq’s NGS liquid biopsy kit is capable of identifying mutations in multiple key tumor driver genes in a single test with world-leading detection performance, and provides companion diagnostics for a range of targeted therapies. This kit is expected to fill the gap and marks a pioneering step in China’s precision oncology healthcare.
The kit uses advanced non-invasive liquid biopsy testing technology to accurately identify tumor-driving mutations by analyzing circulating tumor DNA (ctDNA) in the blood, without the need for tumor tissue samples. As a valuable complement to traditional tumor tissue testing, it greatly assists clinicians for timely treatment-decision making and drives personalized precision medicine.
Dr. Xiaonan Wang, CTO of Geneseeq, stated, “This kit is the third NGS IVD product from Geneseeq to enter the NMPA Innovative Medical Device program, following the previous NMPA approvals of the ‘EGFR/ALK/ROS1/BRAF/KRAS/HER2 Mutation Detection Kit‘ and the ‘GeneseeqPrime NGS TMB Testing Kit‘ for tumor tissue testing. From 6 genes to 400+ genes, from tumor tissue to liquid biopsy testing, Geneseeq has always been patient-need driven, continuously exploring the translation of cutting-edge technologies into clinical practice. The successful inclusion of this kit in the Innovative Medical Device program highlighted Geneseeq’s R&D strength and innovation capability in the field of precision medicine. We believe that with the continuous technology innovation and clinical application, more and more patients will benefit from the technological advancements for life quality improvement.”
