- Genetron Holdings (NASDAQ:GTH) announces that its Ayvakit (avapritinib) companion diagnostic (CDx) kit, developed in partnership with CStone Pharmaceuticals (OTCPK:CSPHF) has entered the priority review and approval process in China.
- Shares down 3% premarket at $18.00.
- During the process, the Center for Medical Device Evaluation carries out a priority technical review, working closely with the company to expedite the process.
- Provincial food and drug authorities also make the review of the product a priority throughout their registered quality management systems.
- The product then goes through a priority administrative process which approves the product at the end.
- Ayvakit has demonstrated remarkable efficacy and acceptable safety in Chinese patients with gastrointestinal stromal tumor (GIST) harboring PDGFRA exon 18 mutations, including D842V.
- As a proprietary companion diagnostic for AYVAKIT, the CDx kit can be used to effectively detect PDGFRA D842V gene mutation in GIST patients, providing accurate molecular diagnosis for targeted drug application.