German medical devices company Leica Biosystems has received the US Food and Drug Administration (FDA) 510(k) approval for its BOND MMR Antibody Panel.
The BOND MMR antibody panel is designed to run on the company’s fully automated multiplex immunohistochemistry (IHC) and (in-situ hybridisation) ISH staining system, BOND-III.
BOND-III is capable of processing up to 30 simultaneous slides to accurately evaluate mismatch repair protein status, within 2.5 hours.
Leica said that the panel provides customers with a high-performing IHC Mismatch Repair (MMR) option when screening colorectal cancer patients for suspected Lynch syndrome.
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 Antibody 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, supporting our mission of Advancing Cancer Diagnostics, Improving Lives.”
Lynch syndrome is a rare inherited cancer susceptibility syndrome that increases the chances of developing colorectal cancer.
Currently, cancer treatment guidelines suggest screening for MMR status with all newly diagnosed CRCs as a preliminary screening method for Lynch syndrome.
Leica said that BOND MMR Antibody Panel provides an IHC MMR option, which is one of the suggested methods of testing in clinical practice.
Established in 1989, Leica Biosystems has more than two decades of experience in developing and manufacturing IHC stains at its facility in Newcastle, UK.
In 2006, the German medical devices company acquired Novocastra to expand its antibodies offering.
In November last year, Leica acquired California-based biotechnology company Cell IDx, which offers multiplex staining panels, tissue staining, and imaging and analysis services.
Cell IDx provides UltraPlex technology that enables the simultaneous detection of various biomarkers, using fluorescent and chromogenic multiplex IHC staining technology.
