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BioWorld - Monday, August 3, 2026
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Home » Qiagen's Therascreen wins supplemental PMA to be used as CDx with BI's Gilotrif
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Qiagen's Therascreen wins supplemental PMA to be used as CDx with BI's Gilotrif

Jan. 22, 2018
By Omar Ford
Qiagen NV has received an expanded PMA indication for its Therascreen diagnostic test to be used in conjunction with Boehringer Ingleheim GmbH's lung cancer therapy, Gilotrif (afatinib). The approval extends the labeling claim to include detection of EGFR mutations L681Q, G719X and S768I to aid the identification of metastatic non-smal-cell lung cancer (NSCLC) patients for whom Gilotrif is indicated.
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