FDA approves therascreen KRAS kit with colorectal cancer drug

Qiagen has announced that its therascreen KRAS RGQ PCR Kit (therascreen KRAS test) has received US Food and Drug Administration (FDA) approval to guide the treatment of metastatic colorectal cancer patients with Amgen’s Vectibix (panitumumab). This marks the third FDA approval of a companion diagnostic from Qiagen that has been paired with a novel medicine.

KRAS mutations, occurring in approximately 40% of colorectal cancer patients, influence response to anti-EGFR therapies such as Vectibix and Erbitux. Screening colorectal cancer patients with therascreen KRAS detects the most frequent mutations in the KRAS gene and helps to guide treatment planning.

“The US approval of our therascreen KRAS test with Amgen’s EGFR inhibitor, Vectibix, marks a further milestone for Qiagen’s global growth in companion diagnostics for personalised healthcare,” said Qiagen CEO Peer M Schatz.

Personalised healthcare is a strategic growth driver for Qiagen, with the company expanding its pipeline of biomarkers and technologies to address the continuously evolving needs of the market. Qiagen is co-developing a range of companion diagnostics under more than 20 project agreements with pharmaceutical and biotech companies, including five master collaboration agreements.

“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 commercialisation of companion diagnostics,” said Schatz.

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