SensID Control Materials for Qiagen Therascreen PIK3CA RGQ PCR Kits

SensID, a Germany-based provider of controls and reference materials for clinical genomics, has introduced a set of controls for Qiagen's US Food and Drug Administration-approved and CE-IVD marked Therascreen PIK3CA RGQ PCR kits. Qiagen's kit was launched in Europe in February 2020 to aid in the identification of activating PIK3CA mutations in FFPE or blood plasma samples from patients with advanced breast cancer. The kit received FDA approval in 2019 and has been commercialized in the US as a companion diagnostic test for alpelisib (Novartis' Piqray).

SensID and Qiagen collaborated to develop the new control materials, which include 11 clinically actionable PIK3CA mutations estimated to be present in approximately 40 percent of HR+/HER2- advanced breast cancer cases and to confer a greater likelihood of responding positively to PI3K inhibitors. The control set contains seven vials (DNA in buffer) in a format matched to the reaction mixes of the Therascreen kit, and each set provides sufficient materials for about 40 runs, the company said. SensID also offers certified DNA-free human plasma that can be used in conjunction with the sample set, if suitable plasma is not available locally.