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Leica Biosystems Nabs 510(k) Clearance for Lynch Syndrome Test

NEW YORK – Danaher subsidiary Leica Biosystems said Monday that it secured US Food and Drug Administration 510(k) clearance for its Bond MMR Antibody Panel to help identify potential Lynch syndrome in colorectal cancer patients.

The cancer diagnostics firm said its Bond MMR Antibody Panel provides IHC mismatch repair protein status within 2.5 hours. The firm said cancer treatment guidelines support screening for MMR status with newly diagnosed colorectal cancers as a preliminary screening method for Lynch syndrome, which is a hereditary disorder involving mutations in DNA repair genes.

Leica President Gustavo Perez-Fernandez said in a statement that the test provides fast, accurate results that help clinicians detect Lynch syndrome.

"Our test enables targeted treatment for patients, supporting our mission of advancing cancer diagnostics, improving lives," he said.