Bio-Rad Announces Innovative Test to Aid in the Diagnosis of Lyme Disease with the FDA Clearance of the BioPlex 2200 Lyme Total Assay

Date: 04/02/2019

HERCULES, Calif.–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.

Bio-Plex and Bio-Rad are trademarks of Bio-Rad Laboratories, Inc. in certain jurisdictions

About Bio-Rad
Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb) is a global leader in developing, manufacturing, and marketing a broad range of innovative products for the life science research and clinical diagnostic markets. With a focus on quality and customer service for over 65 years, our products advance the discovery process and improve healthcare. Our customers are university and research institutions, hospitals, public health and commercial laboratories, biotechnology, pharmaceutical, as well as applied laboratories that include food safety and environmental quality. Founded in 1952, Bio-Rad is based in Hercules, California, and has a global network of operations with more than 8,000 employees worldwide. Bio-Rad had revenues exceeding $2.2 billion in 2018. For more information, please visit www.bio-rad.com.

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Press Contact:
Bio-Rad Laboratories, Inc.
Tina Cuccia, Corporate Communications
510-724-7000
tina_cuccia@bio-rad.com