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 is indicated.
| QIAGEN Receives FDA Approval to Expand Use of EGFR Test in Lung Cancer Extended labeling claim adds detection of three additional gene mutations to provide the most comprehensive mutation panel for GILOTRIF® |
| [18-January-2018] |
| GERMANTOWN, Maryland and HILDEN, Germany, January 18, 2018 /PRNewswire/ -- QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the U.S.Food and Drug Administration (FDA) has approved a PMA supplement extending the indications for use of QIAGEN’s therascreen(R) EGFR RGQ PCR Kit as a companion diagnostic to guide the use of Boehringer Ingelheim’s targeted therapy GILOTRIF(R) (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(R) (afatinib) is indicated. The therascreen(R) EGFR RGQ PCR Kit now detects the most comprehensive panel of EGFR mutations in which the safety and efficacy of GILOTRIF(R) (afatinib) have been established. Click here [https://corporate.qiagen.com/newsroom/press-releases/2017/20180118_therascreen_EGFR?sc_lang=en ] for the full press release. https://corporate.qiagen.com/newsroom/press-releases/2017/20180118_therascreen_EGFR?sc_lan g=en [https://urldefense.proofpoint.com/v2/url?u=https-3A__corporate.qiagen.com_newsroom_press-2Dreleases_2017_20180118-5Ftherascreen-5FEGFR-3Fsc-5Flang-3Den&d=DwMGaQ&c=qwStF0e4-YFyvjCeML3ehA&r=ooUNN5xnz7ArPD5-0mcOWB6L8hlzM7cOxW_ACjFAmlY&m=qwwIHRivEAJtFUD_TlTIq0ZwrCimX299ExKMd5HJuhg&s=mzE9oVeRYTDz4CW9g_43UpBj8HTMIZYPZs9GPryGp4g&e= ] Contacts: QIAGEN Investor Relations John Gilardi e-mail: ir@QIAGEN.com +49-2103-29-11711 Public Relations Dr. Thomas Theuringer e-mail: pr@QIAGEN.com +49-2103-29-11826 SOURCE QIAGEN N.V. | ||
Company Codes: Frankfurt:QIA, NYSE:QGEN, Bloomberg:QGEN@US, Bloomberg:QIA@GR, RICS:QGEN.F, ISIN:NL0000240000 |
