| 2019-05-24 16:57:02|
NVS, QGEN 16:57 05/24 05/24/19
Qiagen launches diagnostic for PIK3CA biomarkers in breast cancer
Qiagen (QGEN) 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 PIQRAY, a newly approved therapy developed and marketed by Novartis (NVS). 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. It is also the first FDA approved assay for guiding treatment decisions in breast cancer using plasma specimens as a liquid biopsy.