Business & Finance
Bio-Rad's SARS-CoV-2 (COVID-19) Serology Test Granted FDA Emergency Use Authorization
1 May 2020 - - US-based life science research and clinical diagnostic products provider Bio-Rad Laboratories, Inc. (NYSE: BIO) has been granted US Food and Drug Administration Emergency Use Authorization for the company's SARS-CoV-2 Total Ab test, the first total antibody test receiving EUA from the FDA, the company said.

Bio-Rad's blood-based immunoassay test can help clinicians identify if an individual has developed antibodies against SARS-CoV-2, the virus associated with COVID-19 disease.

The test has also met the CE mark requirements for Europe.

Clinical evaluation of the SARS-CoV-2 Total Ab test has demonstrated diagnostic specificity of more than 99% and diagnostic sensitivity of 98%.

Cross-reactivity testing demonstrated specificity of 100% with no reactivity against other interfering specimens including non-CoV-2 coronaviruses.

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 Laboratories, Inc. (NYSE: BIO) is in developing, manufacturing, and marketing a range of innovative products for the life science research and clinical diagnostic markets.

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 USD 2.3bn in 2019.