Feb. 21, 2020—Qiagen announced the CE marking and launch of its Therascreen PIK3CA RGQ PCR Kit in Europe as an aid in identifying breast cancer patients with a PIK3CA mutation. The Therascreen PIK3CA test was approved in 2019 by the FDA and launched in the U.S. as a companion diagnostic for Piqray (alpelisib).
“We are convinced that our Therascreen PIK3CA Kit, which expands our market-leading Therascreen portfolio of companion diagnostics, will provide a valuable testing option for those seeking new ways to combat advanced breast cancer,” Jonathan Arnold, vice president, head of oncology and precision diagnostics, at Qiagen, said in a press release. “We are committed to making the Therascreen PIK3CA Kit available immediately so that leading laboratories in Europe can provide patients with the test as soon as possible.”
The assay detects 11 clinically actionable PIK3CA mutations and enables testing of DNA from formalin-fixed, paraffin-embedded tissue or plasma specimens.