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FDA clears Leica Biosystems MMR antibody panel

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April 2023—Leica Biosystems announced FDA 510(k) clearance of the Bond mismatch repair antibody panel for use in screening patients who have colorectal cancer for the identification of Lynch syndrome. The panel is for in vitro diagnostic use on Leica’s Bond-III and Bond-Max immunohistochemistry automated instruments. Turnaround time is 2.5 hours on the Bond-III and about 3.5 hours on the Bond-Max.

Leica Biosystems, 312-565-6737

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