The therascreen PDGFRA RGQ PCR kit was approved by the FDA as a companion diagnostic in the assistance of identifying patients with gastrointestinal stromal tumors (GIST) who could be candidates for avapritinib. The approval was supported by results from the phase 1 NAVIGATOR trial, as well as safety data from a collection of trials assessing avapritinib. Jonathan Arnold, who is the vice president and head of Translational Science and Precision Diagnostics at Qiagen, stated that the therascreen PDGFRA kit delivers results within a quick turnaround time, enabling physicians to receive prompt results and make timely and effective treatment decisions for their patients with GIST.
Reference: Rosa K. FDA Green Lights Companion Diagnostic for Avapritinib in Gastrointestinal Stromal Tumors. OncLive. Published August 8, 2023. Accessed January 12, 2024. https://www.onclive.com/view/fda-green-lights-companion-diagnostic-for-avapritinib-in-gastrointestinal-stromal-tumors
