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Qiagen, Amgen Collaborate to Develop CDx for Investigational NSCLC Drug

NEW YORK – Qiagen said after the close of the market on Monday that it is collaborating with Amgen to develop tissue-based companion diagnostics for Amgen's investigational treatment AMG 510 for non-small cell lung cancer (NSCLC).

The Therascreen CDx test will use real-time PCR to identify patients with cancers that have the KRAS G12C mutation, one of the most common causes of cancer. The RAS gene family includes the most frequently mutated oncogenes in cancers with KRAS being the most prevalent driver in NSCLC.

Qiagen will pursue global regulatory approvals, including premarket approval from the US Food and Drug Administration.

Qiagen said that the agreement focuses initially on CDX tests for NSCLC but allows for further development of tests for Amgen's other oncology clinical development programs.

"Amgen is committed to driving broad accessibility to biomarker testing in order to select appropriate patients who will directly benefit from targeted treatments,” David Reese, executive vice president of R&D at Amgen, said in a statement. "With 1 in 8 patients with NSCLC having KRAS G12C, there's a critical need to improve access to high-quality diagnostics and more routine screening."

Qiagen and Amgen have a long-standing collaboration for CDx development. In 2014 the US Food and Drug Administration approved Qiagen's Therascreen KRAS RGQ PCR test to identify best responders to panitumumab (Amgen's Vectibix).

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