The Food and Drug Administration (FDA) has approved the therascreen® BRAF V600E RGQ PCR Kit (Qiagen) as a companion diagnostic to help identify metastatic colorectal cancer patients eligible for treatment with Braftovi® (encorafenib; Pfizer) in combination with cetuximab. The combination was recently approved for this indication based on results from the phase 3 BEACON trial.

According to the product labeling, confirmation of the presence of a BRAF V600E mutation in tumor specimens is required prior to initiating therapy with Braftovi, as in vitro experiments have demonstrated paradoxical activation of MAP-kinase signaling and increased cell proliferation in BRAF wild-type cells exposed to BRAF inhibitors. Braftovi is not indicated for treatment of patients with wild-type BRAF colorectal cancer.

The therascreen BRAF V600E RGQ PCR Kit consists of 1 mutation and 1 control reaction mix used to detect the V600E mutation in the BRAF gene in tumor tissue taken from a patient with colorectal cancer. The clinical performance of the test was determined in the BEACON study.

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“Using our new test to help guide treatment decisions in colorectal cancer will address a high unmet medical need among patients,” said Jonathan Arnold, Vice President and Head of Partnering for Precision Diagnostics at Qiagen. “The new therascreen BRAF V600E Kit will be available to accelerate the availability of innovations in precision medicine.”

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