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The therascreen® PIK3CA RGQ RT-PCR Kit is a real-time, qualitative PCR assay for the detection of 11 mutations in the PIK3CA gene.
If you have an Integrated Oncology account, order PIK3CA Mutation Analysis by completing the on-line Prognostic/Therapeutic requisition, save to desktop and print.
If not a current client, contact Integrated Oncology to set up an account and to order a test.
The test is intended to aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY® (alpelisib).
PIQRAY® is FDA-approved for use in combination with FDA-approved endocrine therapy fulvestrant, to treat postmenopausal women, and men, with HR+/HER2-, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen.3
The SOLAR-1 clinical trial of PIQRAY® (alpelisib) plus fulvestrant vs. fulvestrant alone in previously treated postmenopausal patients (n=572) with HR+/HER2- advanced breast cancer demonstrated:
These results translate into a 35% reduction in the risk of progression or death, with a hazard ratio of 0.65 in favor of alpelisib in the PIK3CA-mutant cohort (95% CI, 0.50-0.85; P=<0.001).
Testing for PIK3CA mutations may be useful in various clinical settings, including4:
Please see the test menu for specimen requirements.
1. Sabine VS, Crozier C, Brookes CL, et al. Mutational analysis of PI3K/AKT signaling pathway in tamoxifen exemestane adjuvant multinational pathology study. J Clin Oncol. 2014;32(27):2951-2958. doi:10.1200/JCO.2013.53.8272.
2. Aleskandarany MA, Rakha EA, Ahmed MAH, et al. PIK3CA expression in invasive breast cancer: a biomarker of poor prognosis. Breast Cancer Res Treat. 2010;122(1):45-53. doi:10.1007/s10549-009-0508-9.
3. PIQRAY® (alpelisib) [package insert]. East Hanoever, NJ: Novartis Pharmaceuticals Corporation; 2019.
4. Andre F, Ciruelos E, Campone M, et al. Alpelisib for PIK3CA-mutant, HR-positive advanced breast cancer. N Engl J Med. 2019;380:1929-1940. doi:10.1056/NEJMoa1813904.