Analytical and clinical validation of a novel CE-IVD kit for <i>PIK3CA</i> hotspot mutations in liquid biopsy samples.

ABSTRACT: PIK3CA mutations have been implicated in the prognosis and therapeutic response in HER2-positive early breast cancer, with variants located in exon 9 and exon 20 shown to modulate sensitivity to neoadjuvant chemotherapy. Several molecular diagnostic platforms based on PCR or NGS have been developed for the detection of PIK3CA mutations in both tumor tissues and plasma-derived cfDNA, and some commercially available assays have already received FDA approval. The aim of this study was to evaluate the analytical and clinical performance of a novel CE-IVD molecular assay (Oncolipsy, PIK3CA kit, Pharmassist, Greece) for hotspot PIK3CA mutations (p.E542K, p.E545K, p.E545Q, p.H1047R) in liquid biopsy (LB) specimens. Analytical validation included assessment of sensitivity, spe

SUBMITTER: Stergiopoulou D 

PROVIDER: S-EPMC12933448 | biostudies-literature | 2026 Mar

REPOSITORIES: biostudies-literature