HERCULES, Calif. –Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global leader of life science research and clinical diagnostic products, today announced the commercial launch of its SARS-CoV-2 Total Ab test, a blood-based immunoassay kit to help determine if an individual has developed antibodies to SARS-CoV-2, the virus associated with COVID-19 disease. Bio-Rad has applied for Emergency Use Authorization offered by the U.S. Food and Drug Administration and has met the CE mark requirements for Europe.
Bio-Rad’s SARS-CoV-2 Total Ab test can help clinicians identify if an individual has been infected by SARS-CoV-2 and therefore has developed an immune response against the virus. The test detects IgG, IgM, and IgA antibodies, an approach that appears to be more sensitive than assays against a single immunoglobulin1. Clinical evaluation of the SARS-CoV-2 Total Ab test has demonstrated diagnostic specificity of more than 99 percent and diagnostic sensitivity of 98 percent. Cross-reactivity testing demonstrated specificity of 100 percent with no reactivity against other interfering specimens including non-CoV-2 coronaviruses.
Broad-based antibody testing can provide a more complete picture of infection rates and immunity to help public health officials in their efforts to reduce containment orders.
"We are pleased to introduce our SARS-CoV-2 Total Ab test to support COVID-19 diagnosis and population screening," said Dara Wright, Bio-Rad Clinical Diagnostics Group EVP & President. "Having applied for FDA Emergency Use Authorization and meeting the requirements for CE marking, we have begun shipping the test and are in the process of scaling up manufacturing to meet demand in the weeks and months ahead," she said.
The SARS-CoV-2 Total Ab test can be used manually or on an automated immunoassay platform, such as Bio-Rad’s EVOLIS System, which offers high throughput processing and sample traceability.
BIO-RAD and EVOLIS are trademarks of Bio-Rad Laboratories, Inc., in certain jurisdictions.
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 8,100 employees worldwide. Bio-Rad had revenues exceeding $2.3 billion in 2019. 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 regarding 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.
Bio-Rad Laboratories, Inc.
Tina Cuccia, Corporate Communications