HERCULES, Calif. —Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global leader of life science research and clinical diagnostic products, today announced the launch of the Reliance SARS-CoV-2 RT-PCR Kit (IVD) for European markets after having met the CE-IVD mark requirements. The Reliance SARS-CoV-2 RT-PCR Kit is a real-time reverse-transcription PCR (RT-PCR) test that can detect nucleic acid in SARS-CoV-2, the virus associated with COVID-19 disease. A version of the assay kit is also available in the United States under an U.S. Food and Drug Administration (FDA) emergency use authorization (EUA).
The Reliance SARS-CoV-2 RT-PCR Kit (IVD) is designed for clinical diagnostic labs that conduct COVID-19 testing. The assay kits offers the qualitative detection of two separate target regions in the nucleocapsid gene (N1 and N2 regions) of SARS-CoV-2 in nasopharyngeal swab specimens from individuals suspected of being infected by COVID-19. Because they are designed to target the nucleocapsid gene, the assay’s performance is not affected by known coronavirus variants as determined by in-silico analysis. The assay kit contains Bio-Rad’s standard and negative molecular controls as well as assay reagents, and it is validated to run on Bio-Rad’s CFX96 Dx RT-PCR system, as well as RT-PCR systems from other manufacturers.
"We are excited about the European launch of our SARS-CoV-2 RT-PCR Kit (IVD), a reliable, sensitive, and accurate solution for COVID-19 testing," said Steven Blakely, Bio-Rad Global Director of Marketing, Life Science Group, Gene Expression. "Testing laboratories worldwide use Bio-Rad’s RT-PCR systems for the detection of SARS-CoV-2. The assay kit is the latest addition to our COVID-19 offering of research and testing products, reflecting our ongoing commitment to helping in the fight against COVID-19," he said.
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 expectations about our products and regarding our ongoing commitment to helping in the fight against COVID-19. 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.