QIAGEN and Amgen receive FDA approval for Vectibix/therascreen KRAS

May 28, 2014

QIAGEN, a provider of sample & assay technologies, and Amgen, an independent biotechnology company, have announced that QIAGEN’s therascreen KRAS RGQ PCR Kit (therascreen KRAS test) has received FDA approval to guide the treatment of metastatic colorectal cancer patients with Amgen’s Vectibix (panitumumab) a fully human anti-EGFR antibody.

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 may help guide treatment planning.

This announcement comes ahead of the American Society of Clinical Oncology (ASCO) conference, May 30 through June 3, where discussions will focus on the cost and value of cancer treatment. Healthcare professionals’ ability to target and prove value with therapies through companion diagnostics (CDx), such as the therascreen KRAS test, will be an important topic of conversation at ASCO.

The CDx test for Vectibix is the latest U.S. approval of therascreen KRAS and marks the third FDA approval of a CDx from QIAGEN that has been paired with a novel medicine. Prior approvals include the therascreen KRAS test paired with the 2012 approval with Erbitux, and QIAGEN’s therascreen EGFR RGQ PCR Kit (therascreen EGFR test), which was approved by the FDA in 2013 to guide the use of GILOTRIF (afatinib) for treatment of metastatic non-small cell lung cancer (NSCLC). Read the full press release from QIAGEN.

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