HERCULES, Calif. – Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global leader of life science research and clinical diagnostic products, continues to support the worldwide effort to fight SARS-CoV-2, the virus associated with COVID-19 disease. The company offers instruments, tests, and its SARS-CoV-2 Standard to help labs validate their COVID-19 assay results and accelerate access to testing.
Droplet Digital PCR SARS-CoV-2 Test Kit Offers High Sensitivity
Bio-Rad’s Droplet Digital PCR SARS-CoV-2 Test Kit was granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA). This Droplet Digital PCR (ddPCR) SARS-CoV-2 test runs on Bio-Rad’s QX200 and QXDx Droplet Digital PCR Systems. The high sensitivity of the test makes it well suited to screening upper respiratory samples from patients with a low viral load, including individuals in the early stages of infection, compared with classical quantitative PCR tests.
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Bio-Rad’s Highly Sensitive and Specific Antibody Test
Bio-Rad’s Platelia SARS-CoV-2 Total Ab Assay helps clinicians identify whether an individual has developed antibodies against SARS-CoV-2. Clinical evaluation of the Platelia SARS-CoV-2 Total Ab Assay has demonstrated diagnostic specificity of more than 99 percent and diagnostic sensitivity of 98 percent when specimens were collected more than 8 days after onset of symptoms. Cross-reactivity testing has demonstrated specificity of 100 percent with no reactivity against potentially interfering specimens, including other common coronaviruses. This assay has been granted EUA by the U.S. FDA, and it has met CE Mark requirements to be used in Europe.
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Partnering with Testing Labs Worldwide for COVID-19 Testing
Many testing laboratories around the world are utilizing Bio-Rad’s real-time qPCR (RT-qPCR) products for the detection of SARS-CoV-2. These products include Bio-Rad’s CFX Real-Time PCR Detection Systems and reagents such as the company’s Reliance One-Step Multiplex RT-qPCR Supermix.
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Bio-Rad’s Exact Product Line Offers a SARS-CoV-2 Standard for COVID-19
Through its Exact Diagnostics product line, Bio-Rad launched a SARS-CoV-2 Standard to support laboratory assay validation of COVID-19 testing. Bio-Rad’s SARS-CoV-2 Standard helps labs validate their COVID-19 assay results and accelerate access to testing. The Clinical Laboratory Improvement Amendments (CLIA) federal regulatory standards require clinical laboratories to establish and document their own performance specifications for laboratory-developed tests prior to implementation of a test to ensure accurate and precise results. The SARS-CoV-2 Standard contains synthetic COVID-19 RNA transcripts and human genomic DNA, allowing laboratories to test the entire process of a molecular assay, including extraction, amplification, and detection of the virus.
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To learn more about how Bio-Rad’s products support physicians and facilitate SARS-CoV-2 testing and research, please visit SARS-CoV-2 / COVID-19 Assay and Research Solutions.
BIO-RAD, DDPCR, and DROPLET DIGITAL PCR are trademarks of Bio-Rad Laboratories, Inc. in certain jurisdictions. PLATELIA is a trademark of Bio-Rad Europe GmbH in certain jurisdictions. All trademarks used herein are the property of their respective owner.
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 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 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.
Bio-Rad Laboratories, Inc.
Tina Cuccia, Corporate Communications