TEST:

ClearSEEK™ PIK3CA Panel

Mutational hotspots are a recurrent feature in both genes which, due to positive selection during tumorigenesis, can be potentially exploited by targeted treatments, as has been demonstrated by the US Food and Drug Administration (FDA)-approved PI3K inhibitor alpelisib in advanced hormone-receptor positive (HR+) breast cancer... The AGENA ClearSEEK PIK3CA and TP53 Panels combine low hands-on time requirements with accurate data assessment, and provide a reliable tool for clinical trial evaluation of known actionable PIK3CA mutations and response to PI3K inhibitors in breast cancer, as well as for investigating the oncogenic activities of TP53 hotspot mutations and patient selection e.g., for cell cycle targeting therapies.

Mutational hotspots are a recurrent feature in both genes which, due to positive selection during tumorigenesis, can be potentially exploited by targeted treatments, as has been demonstrated by the FDA-approved PI3K inhibitor alpelisib in advanced hormone-receptor positive (HR+) breast cancer... The Agena ClearSEEK PIK3CA and TP53 Panels combine low hands-on time requirements with accurate data assessment and provide a reliable tool for clinical trial evaluation of known actionable PIK3CA mutations and response to PI3K inhibitors in breast cancer, as well as for investigating the oncogenic activities of TP53 hotspot mutations and patient selection, e.g., for cell cycle targeting therapies.

Of the three variants not detected by UltraSEEK®, two were not included in the panel and one was included but not detected. Of the seven variants found in tissue, five could also be detected in the matching saliva samples (71%), either by utilizing ClearSEEK™ or UltraSEEK® The detection of PIK3CA hotspot mutations in OSCC and their simultaneous occurrence in saliva underline the potential benefit of liquid biopsies for non-invasive cancer detection and follow-up care of OSCC patients.

"The PI3K inhibitor alpelisib has been recently approved for the treatment of HR+/HER2- metastatic breast cancer with PIK3CA mutations (PIK3CAmut)... The AGENA ClearSEEK PIK3CA Panel combines both low DNA input and hands-on time requirements with accurate data assessment and provides a high-sensitive and reliable tool to perform PIK3CA analysis of clinically actionable mutations in breast cancer tumors."