On June 18, the “Human KRAS/BRAF/PIK3CA Gene Mutation Combined Detection Kit (Reversible Terminator Sequencing Method)”, independently developed by JUSBIO SCIENCES (SHANGHAI) CO., LTD., was officially approved for market by the National Medical Products Administration (NMPA). This kit is based on DNA probe capture technology and high-throughput sequencing using the reversible terminator sequencing method.

The kit is intended for the qualitative detection of multiple mutations in the KRAS, BRAF, and PIK3CA genes in samples from patients with colorectal cancer (CRC). Among these, KRAS wild‑type results are used as a companion diagnostic for cetuximab injection.

The development and approval of this kit mark another important milestone for JUSBIO in the field of precision oncology diagnostics. Clinical data demonstrate that for the gene mutation sites covered by the kit, the positive percent agreement (PPA), negative percent agreement (NPA), and overall agreement (OA) with the comparator method (digital PCR) all exceed 98%, showing excellent analytical performance and reliability.

Looking ahead, JUSBIO will continue to deepen its efforts in precision oncology diagnostics, leveraging its multi‑omics R&D platform to launch more high‑quality companion diagnostic products, thereby providing comprehensive technical support for clinical precision medicine.