Drug/Device Pipeline

FDA Clears New Test to Aid in Identifying Hereditary Colon Cancer

With further guidance to test all cases of colorectal cancer for possible genetic markers, the FDA cleared the latest test to help distinguish between sporadic and genetic colorectal cancer, according to a release from Roche.

The Ventana mismatch repair (MMR) immunohistochemistry (IHC) test detects proteins linked to MMR – namely MLH1, MSH2, MSH6, PMS2 – and the BRAF antibody to give an indication if the patient is at risk for Lynch Syndrome.

“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 the release. “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 test would point to probably Lynch Syndrome and give physicians further guidance to pursue additional testing.

 

Disclosures: Costello is an employee of Roche.

 

 

 

 

 

 

 

With further guidance to test all cases of colorectal cancer for possible genetic markers, the FDA cleared the latest test to help distinguish between sporadic and genetic colorectal cancer, according to a release from Roche.

The Ventana mismatch repair (MMR) immunohistochemistry (IHC) test detects proteins linked to MMR – namely MLH1, MSH2, MSH6, PMS2 – and the BRAF antibody to give an indication if the patient is at risk for Lynch Syndrome.

“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 the release. “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 test would point to probably Lynch Syndrome and give physicians further guidance to pursue additional testing.

 

Disclosures: Costello is an employee of Roche.