> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Qiagen Gains FDA Approval for Expanded Therascreen Use
- URL: https://www.fdaweb.com/qiagen-gains-fda-approval-for-expanded-therascreen-use/
- Published: 2018-01-19T12:00:00.000Z
- Updated: 2026-09-14T23:15:24.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140550

FDA has approved a Qiagen PMA supplement extending the indications for use of the company’s Therascreen EGFR companion diagnostic to guide the use of Boehringer Ingelheim’s targeted therapy Gilotrif (afatinib) for first-line treatment of metastatic non-small cell lung cancer (NSCLC) with non-resistant epidermal growth factor receptor (EGFR) mutations. The approval extends the labeling claim to include detection of EGFR mutations L681Q, G719X and S768I to aid the identification of NSCLC patients for whom Gilotrif (afatinib) is indicated.