Bio-Rad’s Multi-Target Reliance SARS-CoV-2/FluA/FluB RT-PCR and Reliance SARS-CoV-2 RT-PCR Assay Kits Granted FDA Emergency Use Authorization
HERCULES, Calif. —Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global leader of life science research and clinical diagnostic products, today announced that its Reliance SARS-CoV-2/FluA/FluB RT-PCR and Reliance SARS-CoV-2 RT-PCR Assay Kits were granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA).
The multi-target Reliance SARS-CoV-2/FluA/FluB RT-PCR Assay Kit simultaneously detects and differentiates SARS-CoV-2 (the virus associated with COVID-19), influenza A, and influenza B in a single multiplex reaction. The highly sensitive respiratory pathogen panel is intended for use with nasopharyngeal swabs and anterior nasal swabs. The assay kit includes Bio-Rad positive and negative molecular controls and is validated to run on Bio-Rad's CFX Opus 96, CFX96 Touch, and CFX96 Dx qPCR Systems as well as qPCR systems offered by other manufacturers.
Bio-Rad’s Reliance SARS-CoV-2 RT-PCR Assay Kit is a multiplex test that targets two separate regions in the nucleocapsid gene (N1 and N2 regions) to ensure greater sensitivity and tolerance to potential mutations, which may occur within the viral genome over time, in the detection of SAR-CoV-2. The assay kit contains the company’s standard and negative molecular controls and is validated to run on the CFX Opus 96, CFX96 Touch, and CFX96 Dx qPCR Systems, the CFX Opus 384 and CFX384 Touch Systems for higher throughput testing and is validated to run on qPCR systems offered by other manufacturers.
Designed to target the nucleocapsid gene, the assays are not affected by known coronavirus variants as determined by in-silico analysis.
"As the pandemic continues and with flu season upon us, it’s critical that labs have access to sensitive and reliable tests to help physicians guide patient treatment decisions," said Annette Tumolo, Bio-Rad EVP and President, Life Science Group. "We are pleased to receive the EUA for these two high-performing COVID assays, additional examples of Bio-Rad’s response during the pandemic as well as our ongoing commitment to improving human health."
Testing laboratories worldwide use Bio-Rad qPCR systems for the detection of SARS-CoV-2. The assay kits are the latest additions to Bio-Rad’s portfolio of products related to COVID-19.
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 and pharmaceutical companies, 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 approximately 7,800 employees worldwide. Bio-Rad had revenues exceeding $2.5 billion in 2020. For more information, please visit bio-rad.com.
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 our ongoing commitment to improving human health and our expectations about our 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 the duration and severity of the COVID-19 pandemic, 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 Reports 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.
Tina Cuccia, Manager