Product Press Release
HERCULES, CA – July 6, 2017 – Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global provider of life science research and clinical diagnostic products, today announced FDA clearance for its BioPlex 2200 ToRC IgM Assay.
The BioPlex 2200 ToRC IgM Assay is a fully automated assay for the detection of IgM class antibodies to Toxoplasma gondii, rubella, and cytomegalovirus (CMV) offered in a multiplexed panel. When used together with the BioPlex 2200 System, the BioPlex 2200 ToRC assays, both the IgG and IgM, provide a rapid and comprehensive prenatal testing solution for three of the most clinically significant diseases. Toxoplasma gondii, rubella, and CMV are pathogens commonly associated with congenital diseases and therefore tested during the first trimester of pregnancy.
"The launch of the BioPlex 2200 ToRC IgM panel complements the existing BioPlex 2200 ToRC IgG Assay and provides laboratories with a full serological profile for these markers in an efficient multiplex format," said John Hertia, Bio-Rad President, Clinical Diagnostics Group.
The release of the BioPlex 2200 ToRC IgM Assay is the latest offering for the BioPlex 2200 System, a fully automated multiplex 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-Rad and BioPlex are trademarks of Bio-Rad Laboratories, Inc. in certain jurisdictions.
About Bio-Rad
Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb) develops, manufactures, and markets a broad range of innovative products and solutions for the life science research and clinical diagnostic markets. The company is renowned for its commitment to quality and customer service among university and research institutions, hospitals, public health and commercial laboratories, as well as the biotechnology, pharmaceutical, and food safety industries. Founded in 1952, Bio-Rad is based in Hercules, California, and serves more than 100,000 research and healthcare industry customers through its global network of operations. Bio-Rad employs more than 8,350 people worldwide and had revenues exceeding $2 billion in 2016. For more information, please visit www.bio-rad.com.
Bio-Rad Forward-Looking Statements
This release may be deemed to contain certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements we make regarding plans to introduce products to the molecular diagnostics testing market and our development and launch of new products. Forward-looking statements generally can be identified by the use of forward-looking terminology such as "plan", "believe," "expect," "anticipate," "may," "will," "intend," "estimate," "continue," or similar expressions or the negative of those terms or expressions, although not all forward-looking statements contain these words. Such statements involve risks and uncertainties, which could cause actual results to vary materially from those expressed in or indicated by the forward-looking statements. These risks and uncertainties include our ability to develop and market new or improved products, our ability to compete effectively, international legal and regulatory risks, and product quality and liability issues. For further information regarding our risks and uncertainties, please refer to the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operation" in Bio-Rad’s public reports filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and our Quarterly Report on Form 10-Q. Bio-Rad cautions you not to place undue reliance on forward-looking statements, which reflect an analysis only and speak only as of the date hereof. We disclaim any obligation to update these forward-looking statements.
Press contact:
Bio-Rad Laboratories, Inc.
Tina Cuccia, Corporate Communications
510-724-7000
Email: tina_cuccia@bio-rad.com