CSPHF - Genetron's CDx test Ayvakit enters priority review and approval process in China

Genetron Holdings (GTH) announces that its Ayvakit (avapritinib) companion diagnostic (CDx) kit, developed in partnership with CStone Pharmaceuticals (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.

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Genetron's CDx test Ayvakit enters priority review and approval process in China