LabCorp’s Integrated Oncology specialty laboratory announced it added therascreen PIK3CA PCR mutation analysis, a new companion diagnostic from QIAGE. The CDx identifies postmenopausal women and all men with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-), PIK3CA-mutated, advanced or metastatic breast cancer who could benefit from the Novartis drug Piqray.
Piqray, in combination with fulvestrant, and the therascreen PIK3CA PCR mutation analysis CDx received FDA approval on May 24. LabCorp is able to make the test available quickly after FDA approval through its participation in QIAGEN’s Day-One Lab Readiness program. The companies announced the collaboration under this new program in early April. It allowed LabCorp to begin test validation and development of operating protocols while the test was still under regulatory review speeding readiness of the test.
“Piqray (aplelisib), from Novartis, is the first and only therapy for HR+/HER2- advanced breast cancer with a PIK3CA mutation,” said Marcia Eisenberg, Ph.D., chief scientific officer, LabCorp Diagnostics, in a press release. “Through our collaboration with QIAGEN and participation in their Day-One Lab Readiness Program, LabCorp is able to quickly make new companion diagnostics available to help identify patients who are eligible for the most innovative treatments, individualized to their disease. Enabling patients to gain access to new treatments faster, furthering LabCorp’s mission to improve health and improve lives.”
In addition to the therascreen PIK3CA PCR mutation analysis assay, LabCorp has also recently launched the therascreen FGFR mutation assay by RGQ RT-PCR for bladder cancer through the Day-One program. Multiple other assays, including novel companion diagnostics for lung, colorectal, bladder and other cancers, and eventually pan-tumor disease areas, are currently in LabCorp’s Day-One Lab Readiness pipeline.
“The promise of precision medicine is delivering the right drug to the right patient at the right time, and it can be an absolute game-changer for cancer patients,” said Dr. Dot Adcock, chief medical officer, LabCorp Diagnostics. “LabCorp’s close relationships with numerous hospitals, health systems, cancer clinics and oncologists across the U.S. enables us to provide genetic testing for an increasing number of patients, helping them to more quickly access the targeted therapy that is right for them. We’re seeing extraordinary breakthroughs in precision medicine in oncology patients, and it’s exciting to be a part of these advances in patient care.”