WALTHAM, Mass., Oct. 12, 2020 /PRNewswire/ -- Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today introduced two new SARS-CoV-2 antibody tests: the Thermo Scientific OmniPATH COVID-19 Total Antibody ELISA test, and the Thermo Scientific EliA SARS-CoV-2-Sp1 IgG test. These new tests for detecting COVID-19 antibodies expand the company's leading response to the pandemic, which ranges from molecular diagnostic tests and sample collection products, to personal protective equipment, to support of therapy and vaccine development and manufacturing.
"Thermo Fisher is committed to providing a range of innovative solutions, including new serology tests that complement our PCR-based tests," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "The addition of COVID-19 antibody tests to our broad portfolio further enables our support of the pandemic response on multiple fronts."
OmniPATH COVID-19 Total Antibody ELISA test
The OmniPATH COVID-19 Total Antibody ELISA test, developed in conjunction with the Mayo Clinic and WuXi Diagnostics as previously announced, has been granted Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for qualitative detection of total antibodies to SARS-CoV-2, including immunoglobulin M (IgM), immunoglobulin A (IgA) and immunoglobulin G (IgG).
EliA SARS-CoV-2-Sp1 IgG test
The EliA SARS-CoV-2-Sp1 IgG test is commercially available in accordance with the FDA's "Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)". The EUA is currently under review by the FDA. The EliA test is designed for automated processing of up to 60 results per hour on the Thermo Scientific Phadia 250 instrument. The EliA test is quantitative within markets that accept the CE mark and semi-quantitative in the U.S. Individual IgM and IgA EliA tests are also available now for research use only.
Both of these new antibody tests are designed to meet the need for open ELISA and automated workflows. This flexibility enables laboratories to run the tests at customizable speed and throughput while using automated instruments already in place, minimizing initial costs and reducing the time needed to begin testing. Additionally, these tests are now available in Europe and countries accepting the CE Mark.
About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.