Identify the PIK3CA mutations that matter

PIK3CA in metastatic breast cancer

The Phosphoinositide 3-kinase (PI3K) pathway is one of the most frequently altered pathways in human cancer1. PIK3CA is a gene that encodes a subunit of the PI3K protein, and mutant PIK3CA has been implicated in the pathogenesis of several cancers, including HR+, HER2-  metastatic breast cancer.

Testing for clinically relevant biomarkers, such as PIK3CA, using standardized workflows can help clinicians and patients make informed treatment decisions.

The therascreen PIK3CA RGQ PCR Kit is a clinically validated in vitro diagnostic (IVD) test to identify breast cancer patients that may be eligible for treatment with the ∝-selective PI3K-inhibitor PIQRAY (alpelisib), based on the detection of a PIK3CA mutation.

Reliably detect actionable mutations

The therascreen PIK3CA RGQ PCR Kit is a unique molecular test, based on the detection of specific PIK3CA mutations in tumor DNA isolated from either FFPE tumor tissue or plasma samples. It has proven analytical and clinical validity, and enables detection of all 11 mutations known to be predictive of positive response to PIQRAY (alpelisib), having been evaluated in 572 patients during the independent SOLAR-1 clinical trial. The kit detects 11 mutations in exons 7, 9, and 20 of the PIK3CA gene (exon 7: C420R; exon 9: E542K; E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R; and exon 20: H1047L, H1047R, H1047Y).