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FDA approves Qiagen PIK3CA CDx

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“We are making the Therascreen PIK3CA Kit available immediately following this FDA approval through leading laboratories in the U.S. as a result of Qiagen’s Day-One Lab Readiness program for precision medicine,” Thierry Bernard, senior VP and head of Qiagen’s molecular diagnostics business area, said in a release. “We are convinced that our new Therascreen PIK3CA Kit, which expands our market-leading Therascreen portfolio of companion diagnostics, and the approval of Piqray together provide a valuable treatment option for those searching for new ways to combat advanced breast cancer.”

The real-time qualitative PCR kit is processed on the company’s Rotor-Gene Q MDx.

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