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Bio-Rad Lyme Assay FDA Cleared

NEW YORK (360Dx) – Bio-Rad Laboratories announced today its assay for Lyme disease has received clearance from the US Food and Drug Administration.

The Lyme Total Assay is an immunoassay that detects multiple targets using ligand-coated beads. It runs on the firm's BioPlex 2200 System, an automated and random-access multiplex platform.

The system enables users to load a tray of primary tubes and walk away, and it can automatically process 100 samples per hour with first results available after about 60 minutes and subsequent samples completed every 30 seconds, according to the firm's website.

"The addition of the BioPlex 2200 Lyme Total assay broadens our BioPlex 2200 System infectious disease menu, offering laboratories the ability to detect Lyme disease at an early stage and thus fulfilling an important medical need in the management of Lyme disease," said John Hertia, president of Bio-Rad's clinical diagnostics group.

The menu for the BioPlex 2200 also includes multiplex panels for autoimmune diseases and other infectious diseases. Last year Bio-Rad received clearance for its BioPlex 2200 25-OH Vitamin D Kit for assessing vitamin D sufficiency.