Companion Dx Test for Iressa Receives Marketing Approval

Qiagen announced that it has received marketing approval from the Food and Drug Administration (FDA) for its therascreen EFGR RGQ PCR Kit as a companion diagnostic to Iressa (geftinib; AstraZeneca) for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC). The therascreen EGFR test is intended to help doctors identify eligible NSCLC patients who are positive for epidermal growth factor receptor (EGFR) mutations.

The therascreen EGFR test consists of a plasma kit that analyzes EGFR mutation status from blood. It is the first “liquid biopsy” regulatory registration of a companion diagnostic to help solid-tumor patients for whom surgical biopsies are not assessable. Iressa, a tyrosine kinase inhibitor, was approved on July 13, 2015 as first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.

RELATED: Iressa Approved as First-Line Metastatic NSCLC Tx

This marks the second approved use for the therascreen EGFR test in NSCLC.

For more information visit Qiagen.com.

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