Qiagen N.V. announced that the US Food and Drug Administration (FDA) has approved a PMA supplement extending the indications for use of Qiagen’s therascreen EGFR RGQ PCR Kit as a 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. The therascreen EGFR RGQ PCR Kit now detects the most comprehensive panel of EGFR mutations in which the safety and efficacy of Gilotrif (afatinib) have been established.
“As precision medicine develops increasing sophistication to guide the use of medicines based on individual genomic variations, we are pleased to provide benefits to more lung cancer patients with these additional biomarkers in our clinically proven therascreen EGFR RGQ PCR Kit. Our collaboration with Boehringer Ingelheim, which led to FDA approvals of Gilotrif and our companion diagnostic in 2013, continues to improve personalized healthcare for patients around the world,” said Jonathan Arnold, vice president and head of Qiagen’s Partnering for Precision Diagnostics unit. “In addition to detecting the most comprehensive panel of EGFR mutations in which the safety and efficacy of Gilotrif (afatinib) have been established, the therascreen EGFR RGQ PCR Kit offers laboratories an efficient workflow on the Rotor-Gene Q MDx, the real-time PCR module in our widely-used QIAsymphony family of instruments.”
Qiagen is a pioneer in Personalized Healthcare and the global leader in collaborations with pharmaceutical and biotechnology companies to co-develop companion diagnostics, which detect genetic abnormalities to provide insights that guide clinical decision-making on the use of drugs in diseases such as cancer. In 2017, Qiagen announced that is working under master collaboration agreements with more than 25 pharmaceutical companies to develop companion diagnostic tests for their drug candidates. Qiagen expects more than 5 FDA submissions and/or US launches in 2018.
Qiagen N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life.