FDA Approves Qiagen’s therascreen as Companion Diagnostic Test for Lung Cancer Treatment
Qiagen, the provider of sample and assay technologies for various diagnostic purposes has now announced the FDA approval of its therascreen EGFR RGQ PCR Kit is an FDA-approved, qualitative real-time PCR assay for the detection of specific mutations in the EGFR oncogene.
The kit includes reagents designed for rapid and sensitive detection of 21 somatic mutations of the human EGFR gene using the QIAamp® DSP DNA FFPE Tissue Kit and the Rotor-Gene Q MDx instrument.
A PMA supplement has been received, 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.
“We are pleased to provide benefits to more lung cancer patients with these additional biomarkers in our clinically proven therascreen EGFR RGQ PCR Kit,” Jonathan Arnold, VP and head of Qiagen’s Partnering for Precision Diagnostics unit, said in a statement.
“In addition to detecting the most comprehensive panel of EGFR mutations in which the safety and efficacy of Gilotrif 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,
” Arnold added.
