QIAGEN launches therascreen BRAF test as companion diagnostic to a BRAFTOVI® (encorafenib) based regimen in metastatic colorectal cancer

(PresseBox) ( Germantown, Maryland /Hilden, )
• U.S. FDA approves therascreen BRAF V600E RGQ PCR assay as companion diagnostic
• Test will help identify patients eligible for treatment with the BRAF inhibitor, BRAFTOVI, which the FDA has approved for use in combination with ERBITUX® (cetuximab) in adults with previously treated metastatic colorectal cancer with a BRAF V600E mutation

QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced launch of its novel therascreen® BRAF V600E RGQ PCR Kit (therascreen BRAF V600E Kit) following U.S. Food and Drug Administration (FDA) approval as a companion diagnostic to the BRAF inhibitor, BRAFTOVI® (encorafenib), which the FDA has approved 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.

Colorectal cancer is the third most common type of cancer, and approximately 150,000 patients a year in the United States are diagnosed with CRC. 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 assays will help identify patients eligible for treatment with the newly approved combination of BRAFTOVI and cetuximab. The therascreen BRAF V600E kit runs on QIAGEN’s Rotor-Gene Q MDx, a member of the modular QIAsymphony family of automation solutions.

“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 CDx approval in colorectal cancer. 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.”

QIAGEN is a pioneer in precision medicine and the global leader in collaborations with pharmaceutical and biotechnology companies to co-develop companion diagnostics, which detect clinically relevant genetic abnormalities to provide insights that guide clinical decision-making on the use of drugs in diseases such as cancer. QIAGEN has an unmatched depth and breadth of technologies from NGS to PCR for companion diagnostic development and is currently working under master collaboration agreements with more than 25 companies to develop and commercialize companion diagnostic tests for their drug candidates. The recent therascreen BRAF V600E approval marks the 8th FDA approval of a therapy with a QIAGEN companion diagnostic assay.

For more information on QIAGEN’s companion diagnostics please visit www.qiagen.com/braf
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