Qiagen Nabs CE Mark for Breast Cancer Mutation Diagnostic

Qiagen has received CE Mark certification for its Therascreen PIK3CA RGQ PCR diagnostic kit, a test used to identify breast cancer patients with a certain mutation.

The real-time qualitative PCR assay is used with Qiagen’s Rotor-Gene Q MDx instrument and in vitro diagnostic DNA sample preparation kits to detect 11 clinically actionable PIK3CA mutations.

The mutations are estimated to be present in approximately 40 percent of hormone receptor-positive, HER2-negative advanced breast cancer cases.