Labcorp and its Specialty Testing Group, a fully integrated portfolio of specialty and esoteric testing laboratories.
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 therascreen® PIK3CA RGQ RT-PCR Kit is a real-time, qualitative PCR assay for the detection of 11 mutations in the PIK3CA gene.
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.