Bio-Rad Receives FDA Emergency Use Authorization for Droplet Digital PCR SARS-CoV-2 Test Kit
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 SARS-CoV-2 Droplet Digital PCR (ddPCR) test kit has been granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA). The SARS-CoV-2 Droplet Digital PCR (ddPCR) test runs on Bio-Rad's QX200 and QXDx ddPCR systems.
The high sensitivity of the test makes it well suited to screening upper respiratory samples in patients with a low viral load, including individuals in the early stages of infection as compared to classical quantitative PCR tests. The test can also play an important role in surveillance by detecting minimal residual disease in people recovering from COVID-19 informing them if they are negative for the virus. Bio-Rad’s single-well SARS CoV-2 ddPCR test provides clinicians with a high degree of sensitivity that can significantly improve the accuracy of reported results.
According to the World Health Organization, regular, accurate testing of COVID-19 is a key component in the fight against the global pandemic.
"We are pleased to receive Emergency Use Authorization for our SARS-CoV-2 ddPCR test that offers high sensitivity in detecting infection of COVID-19 at an early stage," said Simon May, Senior Vice President of Bio-Rad’s Digital Biology Group. "We believe the test will be a powerful complement to current diagnostics, helping clinicians and public health officials accurately identify infected individuals in a timely manner. With the EUA, our test is now available to clinical labs in the U.S.," he said.
Thousands of hospitals and molecular testing labs in the U.S. and around the world have Bio-Rad’s QX200 and QXDx ddPCR systems installed and have the capacity to perform SARS-CoV-2 ddPCR testing. The SARS-CoV-2 ddPCR test represents the latest addition to Bio-Rad’s product offerings related to COVID-19. This is the second EUA Bio-Rad has been granted for COVID-19. Last week, the company received an EUA for a serology test to detect antibodies to the virus.
BIO-RAD, DROPLET DIGITAL PCR, and ddPCR, 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.
The SARS-CoV-2 ddPCR Test Kit has been authorized for emergency use by FDA under an EUA as described in this document.
This device is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the SARS-CoV-2 ddPCR Test Kit under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the authorization is terminated or revoked sooner.
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 belief that our SARS-CoV-2 ddPCR test will be a powerful complement to current diagnostics, helping clinicians and public health officials accurately identify infected individuals in a timely manner, and 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