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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.

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