Netherlands-based Qiagen has obtained approval from the US Food and Drug Administration (FDA) for its therascreen KRAS RGQ PCR kit to guide the treatment of metastatic colorectal cancer patients with Amgen’s Vectibix (panitumumab).
Qiagen claims that screening colorectal cancer patients with therascreen KRAS detects the most frequent mutations in the KRAS gene and helps to guide treatment planning.
Qiagen CEO Peer Schatz said that the US approval of the company’s therascreen KRAS test with Amgen’s EGFR inhibitor, Vectibix, marks a further milestone for its global growth in companion diagnostics for personalized healthcare.
"Our success in this long-standing collaboration with Amgen is a further demonstration of QIAGEN’s capabilities as a preferred partner of pharmaceutical and biotech companies for co-development and commercialization of companion diagnostics," Schatz added.
Qiagen received FDA approval in 2013 for the therascreen EGFR RGQ PCR kit to guide the use of Gilotrif (afatinib) for treatment of metastatic non-small cell lung cancer.