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Qiagen Obtains CE Mark for PIK3CA Mutation Assay

NEW YORK – Qiagen said on Monday that it has obtained CE marking for its Therascreen PIK3CA RGQ PCR kit to aid in identifying breast cancer patients with a PIK3CA mutation.

As such, the test is now commercially available in Europe. The real-time qualitative PCR assay is performed on Qiagen's Rotor-Gene Q MDx instrument and uses the company's QIAamp in vitro diagnostic DNA sample prep kits for formalin-fixed paraffin-embedded tissue and plasma.

The assay detects 11 clinically actionably PIK3CA mutations, which are estimated to be present in about 40 percent of hormone receptor-positive, HER2-negative advanced breast cancer cases. Qiagen has a worldwide co-exclusive license from Johns Hopkins University for PCR-based companion diagnostics based on detection of mutations in PIK3CA.

Qiagen codeveloped the test in collaboration with Novartis in the US as a companion diagnostic for alpelisib (Piqray). The assay received US Food and Drug Administration approval for this use in May.

"We are convinced that our Therascreen PIK3CA Kit … will provide a valuable testing option for those seeking new ways to combat advanced breast cancer," Jonathan Arnold, vice president and head of oncology and precision diagnostics at Qiagen, said in a statement.