CLN - Regulatory Roundup

Roche Receives CE Mark for Test to Identify Hereditary Colon Cancer

Regulatory Roundup: March 2018

The CE mark has been granted to Roche’s Ventana MMR IHC panel, a comprehensive group of immunohistochemistry tests for patients diagnosed with colorectal cancer (CRC). The panel detects proteins associated with a DNA repair mechanism called mismatch repair (MMR) in order to differentiate between sporadic CRC and probable Lynch syndrome, a hereditary condition that confers a 50 to 80% lifetime risk of developing CRC. Identifying patients with Lynch syndrome helps their family members make informed decisions about further genetic testing and advanced monitoring to detect colorectal cancer early. The Ventana MMR IHC panel includes four assays that target the MMR proteins MLH1, PMS2, MSH2, and MSH6, as well as the Ventana BRAF V600E (VE1) assay. The Ventana BRAF V600E (VE1) antibody helps refine the identification of patients who should receive additional testing for Lynch syndrome in the absence of MLH1 protein expression.

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