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FDA clears Roche panel for colorectal cancer

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Nov. 14, 2017Roche announced today FDA clearance of the Ventana MMR IHC Panel, which provides clinicians with a group of immunohistochemistry tests for patients diagnosed with colorectal cancer. The tests detect certain proteins associated with a DNA repair mechanism called mismatch repair and aid in differentiating between sporadic colorectal cancer and probable Lynch syndrome, a hereditary form of colorectal cancer. About three percent of colorectal cancers are associated with Lynch syndrome.

The panel of five assays includes four that target MMR proteins MLH1, MSH2, MSH6, and PMS2 and the Ventana BRAF V600E (VE1) assay. This is the first FDA clearance of an IHC panel of this type, the company says.

“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,” Ann Costello, head of Roche tissue diagnostics, said in a statement. “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 panel is available for use on the BenchMark Ultra instrument.

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