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Tuesday, April 2, 2019

BioRad: Innovative Lyme Disease Diagnostic Test with FDA Clearance

Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global leader of life science research and clinical diagnostic products, today announced that it has received U.S. Food and Drug Administration (FDA) clearance for its BioPlex 2200 Lyme Total Assay, an innovative multiplex test method to aid in the diagnosis of Lyme disease.
Lyme disease is the most common tick-borne illness in the United States. Many signs and symptoms of the disease are similar to other conditions so diagnosis can be challenging; however, individuals immediately treated for the disease usually recover rapidly and completely. The BioPlex 2200 Lyme Total Assay can simultaneously detect multiple targets, providing laboratories valuable information in the early stages of Lyme disease so patients are able to receive treatment as quickly as possible.
“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, Bio-Rad President, Clinical Diagnostics Group.
The release of the BioPlex 2200 Lyme Total assay is the latest offering in Bio-Rad’s infectious disease menu for the BioPlex 2200 System, an automated multiplex technology platform. The BioPlex 2200 System provides clinical laboratories the capability to rapidly process or “multiplex” multiple individual tests that are traditionally processed separately, conserving patient sample volume and simplifying workflow.

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