TEST:

AYVAKIT® CDx test

"CStone Pharmaceuticals...announced that the AYVAKIT® (avapritinib) companion diagnostic (CDx) kit, known as 'Human platelet-derived growth factor receptor alpha (PDGFRA) Gene D842V Mutation Detection Kit', developed in partnership with Genetron Holdings Limited (Genetron Health) has been approved by the China National Medical Products Administration (NMPA). This CDx kit is the first companion diagnostic product co-developed through the bridging pathway in China to gain regulatory approval following the release of the companion diagnostic guidelines by NMPA. It is used to detect PDGFRA gene mutations in gastrointestinal stromal tumor (GIST) for patients receiving treatment with AYVAKIT."