CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
June 3, 2019—Qiagen announced the launch of its Therascreen PIK3CA RGQ PCR Kit after it received U.S. regulatory approval as a companion diagnostic to aid in identifying breast cancer patients eligible for treatment with alpelisib (Piqray, Novartis), which was co-approved by the FDA.
The Therascreen PIK3CA Kit is the first companion diagnostic assay to obtain premarket approval from the FDA for use in any cancer indication for detection of activating mutations in the PIK3CA gene, the company said, and the first FDA-approved assay for guiding treatment decisions using plasma specimens as a liquid biopsy. The assay detects 11 PIK3CA mutations, which are estimated to be present in approximately 40 percent of hormone receptor–positive advanced or metastatic breast cancer patients.