Thermo Fisher Scientific Further Expands COVID-19 Test Portfolio with Two New Antibody Tests

Rhea-AI Summary

Thermo Fisher Scientific (NYSE: TMO) has launched two new SARS-CoV-2 antibody tests: the OmniPATH COVID-19 Total Antibody ELISA and EliA SARS-CoV-2-Sp1 IgG tests. The OmniPATH test has received Emergency Use Authorization (EUA) from the FDA for detecting total antibodies, while the EliA test is commercially available with its EUA currently under review. These tests enhance the company’s portfolio in response to the COVID-19 pandemic, allowing laboratories to conduct testing with greater efficiency and flexibility. Thermo Fisher's annual revenue exceeds $25 billion.

Positive

• Launch of two new antibody tests for COVID-19 enhances product portfolio.
• OmniPATH test granted Emergency Use Authorization by the FDA.
• EliA test designed for automated processing, increasing testing efficiency.

Negative

• EliA test's EUA is still under review, causing uncertainty in availability.
• Dependence on regulatory approvals may delay market penetration.

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.

Media Contact Information:
Ron O'Brien
Phone: 781-622-1242
E-mail: ron.obrien@thermofisher.com

Investor Contact Information:
Ken Apicerno
Phone: 781-622-1294
E-mail: ken.apicerno@thermofisher.com

 

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SOURCE Thermo Fisher Scientific

FAQ

What are the new tests introduced by Thermo Fisher Scientific?

Thermo Fisher introduced the OmniPATH COVID-19 Total Antibody ELISA test and the EliA SARS-CoV-2-Sp1 IgG test.

What is the significance of the OmniPATH test's Emergency Use Authorization?

The EUA allows the OmniPATH test to be used for the qualitative detection of total antibodies to SARS-CoV-2 in the U.S.

What is the current status of the EliA SARS-CoV-2-Sp1 IgG test?

The EliA test is commercially available, but its Emergency Use Authorization is currently under review by the FDA.

How do these new tests impact Thermo Fisher Scientific's market position?

The introduction of these tests expands Thermo Fisher's COVID-19 response capabilities, reinforcing its leadership in the biomedical industry.

Where are Thermo Fisher's new antibody tests available?

The new tests are available in Europe and other countries that accept the CE Mark.