PIK3CA mutation testing – quick and easy! That this is possible was shown by our successful participation in the round robin test of PIK3CA (tissue and liquid biopsy) organized by QuiP, the external quality assessment service in Germany.

Due to the recent approval of alpelisib by the European Commission for the treatment of patients with HR +/HER2- advanced breast cancer, it is necessary that the laboratories are able to provide validated tests for PIK3CA mutations, as they will decide whether patients are eligible for treatment with alpelisib or not.

  • EasyPGX® ready PIK3CA is a Real Time PCR-based CE-IVD test for the mutational analysis of the PIK3CA gene.
  • EasyPGX® ready PIK3CA detects the most frequent mutations of codons 345, 420, 542, 545, 546, 1047, 1049 of the PIK3CA gene.
  • EasyPGX® ready PIK3CA can be used with DNA isolated from fresh, frozen or FFPE tissue or from plasma.
  • EasyPGX® ready PIK3CA turnaround time, from sample to result, is less than 3 hours with a hands-on time of 10 minutes. 
  1. PIK3CA Mamma Gewebe (Molpath) certificate
  2. PIK3CA Mamma Liquid Biopsy – artifizielle Proben (Fragmente 490 bp) certificate