Ventana MMR IHC Panel for Patients Diagnosed With Colorectal Cancer Receives FDA Clearance

On November 14, the U.S. Food & Drug Administration (FDA) granted clearance to the Ventana MMR IHC Panel, which provides clinicians with a comprehensive group of immunohistochemistry (IHC) tests for patients diagnosed with colorectal cancer. The tests detect proteins associated with the DNA mismatch repair (MMR) mechanism and aid in differentiating between sporadic colorectal cancer and probable Lynch syndrome. About 3% of colorectal cancers are associated with Lynch syndrome.

The panel of five assays includes four that target the MMR proteins MLH1, MSH2, MSH6, and PMS2, as well as the Ventana BRAF V600E assay. This is the first FDA clearance of an IHC panel of this type.

Colorectal cancer, the third leading cause of cancer-related deaths in women in the United States and the second leading cause in men, is expected to result in more than 50,000 deaths in the United States in 2017. Increasingly, guidelines, including those from the National Comprehensive Cancer Network, are recommending universal screening of all newly diagnosed colorectal cancers for Lynch syndrome.

Lynch syndrome results in a 50% to 80% lifetime risk of developing colorectal cancer, making it important to identify the syndrome in colorectal cancer patients and at-risk family members. Identification of the syndrome may result in early detection and possible cancer prevention among those with the inherited mutation.

“The Ventana MMR IHC Panel provides clinicians with an additional tool to perform universal tumor screening for probable Lynch syndrome as recommended by medical guidelines,” said Ann Costello, Head of Roche Tissue Diagnostics. “The FDA clearance is a major milestone because this testing impacts not just the patient, but family members who may benefit from further genetic testing and advanced monitoring to detect colorectal cancer at its earlier stages, when it is more treatable.”

The ready-to-use Ventana MMR IHC Panel is optimized for use with the OptiView DAB IHC Detection Kit, OptiView Amplification Kit, and ancillaries on the fully automated BenchMark ULTRA system.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.




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