Qiagen therascreen EGFR RGQ PCR Kit

Qiagen has received approval by the US FDA to market the therascreen EGFR test as a companion diagnostic to guide the use of Boehringer Ingelheim’s targeted therapy GILOTRIF (afatinib) for treatment of metastatic NSCLC in patients whose tumours have certain EGFR gene mutations. The test enables doctors to identify EGFR mutation-positive patients eligible for treatment with GILOTRIF (afatinib).

EGFR (the epidermal growth factor receptor) is a protein found on the surface of cells. In some patients, genetic mutations involving EGFR lead to constant activation, which is associated with uncontrolled cell division and development of advanced NSCLC. By using a companion diagnostic to identify patients whose cancer involves these EGFR mutations, oncologists can determine who is likely to benefit from targeted therapy that inhibits the EGFR protein.

Analytical performance of the therascreen EGFR test has been established for 21 EGFR mutations, including the most prevalent resistance mutation (T790M). The test also includes certain features that are valuable for pathologists, such as the detection of EGFR mutations in separate tubes.

The kit covers the complete workflow, from sample preparation to detection technology, through the generation of test reports by the Rotor-Gene Q MDx, a molecular detection instrument that uses real-time PCR technology. This standardised workflow delivers reproducible and objective results for oncologists. Qiagen will provide laboratories with conversion and validation support for the EGFR test, plus ongoing assistance with co-marketing and reimbursement.