Leica Biosystems has received the US Food and Drug Administration (FDA) 510(k) approval for its Bond MMR Antibody Panel.
The move will offer clients a high-performing IHC Mismatch Repair (MMR) choice while screening colorectal cancer patients for the identification of probable Lynch syndrome.
Pathologists can evaluate the status of mismatch repair protein using the Leica Biosystems BOND MMR panel on the BOND-III in just 2.5 hours, the company claims.
Leica Biosystems chief medical officer Dr Robert Monroe said: “With this panel, clinicians can feel increased confidence in their MMR results.”
Globally, colorectal cancer (CRC) is the third most diagnosed cancer. Lynch syndrome is a rare inherited cancer susceptibility syndrome that raises the risk of getting colorectal cancer and is believed to be responsible for 3%-5% of all cases, according to the American Society of Clinical Oncology (ASCO).
The importance of checking for MMR status with all recently diagnosed CRCs as a preliminary Lynch syndrome screening technique is supported by current cancer treatment recommendations.
IHC is one of the recommended testing methods that is increasingly being used in clinical settings.
Leica Biosystems President Gustavo Perez-Fernandez said: “Leica Biosystems is proud to help our customers continue the fight against cancer through the fast, accurate results of the BOND MMR Panel, which provides the clinicians with an important piece of the diagnostic puzzle in aiding the detection of Lynch syndrome.
“Our test enables targeted treatment for patients, enabling our mission of ‘Advancing Cancer Diagnostics, Improving Lives’.”