Roche Tissue Diagnostics Media Relations
Senior Manager, External Communications
Tucson, AZ, November 14, 2017 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced US Food & Drug Administration (FDA) clearance of 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 certain proteins associated with a DNA repair mechanism called mismatch repair (MMR), and aid in differentiating between sporadic colorectal cancer and probable Lynch syndrome, a hereditary form of colorectal cancer. About 3 percent of colorectal cancers are associated with Lynch syndrome.2
The panel of five assays includes four that target MMR proteins MLH1, MSH2, MSH6 and PMS2, as well as the VENTANA BRAF V600E (VE1) 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 US and the second leading cause in men, is expected to result in more than 50,000 deaths in the US in 2017.3 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 percent lifetime risk of developing colorectal cancer,4 making it important to identify the syndrome in colorectal cancer patients and at-risk familymembers. Identification of the syndrome may result in early detection and possible cancer prevention among those with the inherited mutation.5
“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 VENTANA MMR IHC Panel is available for use on the BenchMark ULTRA instrument.
The FDA-cleared VENTANA MMR IHC Panel consists of VENTANA anti-MLH1 (M1), VENTANA anti-PMS2 (A16-4), VENTANA anti-MSH2 (G219-1129), VENTANA anti-MSH6
(SP93) antibodies, for patients diagnosed with colorectal cancers for the detection of mismatch repair protein deficiency as an aid in the identification of probably Lynch syndrome, and VENTANA BRAF V600E (VE1) antibody as an aid to differentiate between sporadic colorectal cancer and probable Lynch syndrome.
The VENTANA MMR IHC Panel is the first panel of this type to receive FDA clearance.
The inclusion of the VENTANA BRAF V600E (VE1) antibody helps refine the number of patients who may 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 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.
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VENTANA, BENCHMARK, ULTRA and OPTIVIEW are trademarks of Roche. Other product names and trademarks are the property of their respective owners.