Leica Biosystems Strengthens Portfolio with FDA Clearance of Class II Mismatch Repair (MMR) Panel

The BOND MMR Antibody Panel is now available for clinical use on BOND-III and BOND-MAX Immunohistochemistry (IHC) automated instruments.

NEWCASTLE, United Kingdom, April 3, 2023 /PRNewswire/ -- Leica Biosystems today announced the US Food and Drug Administration (FDA) 510(k) clearance of the BOND MMR Antibody Panel, providing customers with a high-performing IHC Mismatch Repair (MMR) option when screening colorectal cancer patients for the identification of probable Lynch syndrome.

"Pathologists can utilize the Leica Biosystems BOND MMR Antibody Panel on the BOND-III for clear, accurate assessment of mismatch repair protein status in only 2.5 hours," said Dr. Robert Monroe, Chief Medical Officer at Leica Biosystems. "With this panel, clinicians can feel increased confidence in their MMR results."

Colorectal cancer (CRC) is the third most diagnosed cancer worldwide. Approximately 3-5% of all cases are thought to be due to Lynch syndrome, a rare inherited cancer susceptibility syndrome that increases the likelihood of developing colorectal cancer.[1]

Current cancer treatment guidelines support the importance of screening for MMR status with all newly diagnosed CRCs as a preliminary screening method for Lynch syndrome. IHC is one of the suggested methods of testing, used increasingly in clinical practice.  

"Leica Biosystems is proud to help our customers continue the fight against cancer through the fast, accurate results of the BOND MMR Antibody Panel, which provides the clinicians an important piece of the diagnostic puzzle in aiding the detection of Lynch syndrome," said Gustavo Perez-Fernandez, President of Leica Biosystems. "Our test enables targeted treatment for patients, supporting our mission of Advancing Cancer Diagnostics, Improving Lives."

Leica Biosystems has more than 20 years of experience developing and manufacturing IHC stains at its Newcastle, UK facility. With the 2006 acquisition of Novocastra, the company expanded its menu of antibodies and continues to innovate to offer laboratories clinically relevant antibodies for the most demanding workload. The BOND MMR Antibody Panel with 510(k) clearance is the company's latest offering.

About Leica Biosystems

Leica Biosystems is a cancer diagnostics company and a global leader in workflow solutions. Only Leica Biosystems offers the most comprehensive portfolio that spans the entire workflow from biopsy to diagnosis. With unique expertise, we are dedicated to driving innovations that connect people across radiology, pathology, surgery and oncology. Our experts are committed to delivering Improved Quality, Integrated Solutions, and Optimized Efficiencies leading to breakthrough advances in diagnostic confidence. Our mission of "Advancing Cancer Diagnostics, Improving Lives" is at the heart of our corporate culture. Visit LeicaBiosystems.com for more information.

For In Vitro Diagnostics Use

SOURCE Leica Biosystems