Qiagen, Hilden, Germany, has launched  its novel Therascreen BRAF V600E RGQ PCR kit, following its approval by FDA as a companion diagnostic to the BRAF inhibitor, encorafenib (Braftovi). FDA previously approved encorafenib for use in combination with cetuximab for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.

Jonathan Arnold, Qiagen.

Jonathan Arnold, Qiagen.

Colorectal cancer is the third most common type of cancer, and approximately 150,000 patients a year in the United States are diagnosed with it. In primary and metastatic CRC, BRAF mutations (nearly always V600E) are present in up to 15% of patients and are thought to be key drivers of tumor growth.

Detection of the V600E mutation utilizing the Therascreen BRAF V600E assay will help identify patients eligible for treatment with the newly approved combination of encorafenib and cetuximab. The Therascreen BRAF V600E kit runs on Qiagen’s Rotor-Gene Q MDx instrument.

“We are very excited about the launch of the new Therascreen BRAF V600E kit, our first companion diagnostic test to obtain FDA approval for the detection of a mutation in the BRAF gene and our third companion diagnostic approval in colorectal cancer,” says Jonathan Arnold, vice president and head of partnering for precision diagnostics at Qiagen. “Using our new test to help guide treatment decisions in colorectal cancer will address a high unmet medical need among patients.”

For further information, visit Qiagen.