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Roche Gets FDA Clearance for Colorectal Cancer IHC Panel

NEW YORK (360Dx) – Roche said today that the US Food and Drug Administration has granted clearance for its Ventana MMR IHC panel, which provides clinicians with "a comprehensive group of immunohistochemistry tests" for patients diagnosed with colorectal cancer.

The tests detect proteins associated with a DNA mismatch repair mechanism, and aid in differentiating between sporadic colorectal cancer and probable Lynch syndrome, a hereditary form of colorectal cancer.

The newly cleared 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.

She noted that the FDA clearance is a milestone because this type of testing impacts not just the patient, but family members who could "benefit from further genetic testing and advanced monitoring to detect colorectal cancer at its earlier stages, when it is more treatable."

The cleared panel has five assays — the firm's Ventana BRAF V600E assay and four other assays that target the MMR proteins MLH1, MSH2, MSH6, and PMS2.

Roche said that the inclusion of the Ventana BRAF V600E (VE1) antibody helps refine the number of patients who could receive additional testing for Lynch syndrome by aiding in the differentiation between sporadic colorectal cancer and probable Lynch syndrome in the absence of MLH1 protein expression.

The cleared panel of assays is available for use on the Roche BenchMark Ultra instrument.

The FDA's green light marks the first for an IHC panel of this type, Roche said.

About 3 percent of colorectal cancers are associated with Lynch syndrome, according to the firm.