Thermo Fisher Scientific Inc has 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 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.
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).
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.
“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.”
The company also plans to develop two new sterile filling lines in Singapore to extend capacity to the Asia-Pacific region for the development and manufacture of therapies and vaccines.
Established with the support of the Singapore Economic Development Board, the US$130M facility will be operated by Thermo Fisher and have the capability to manufacture pharmaceutical products to meet demand in the region and respond effectively to future health emergencies.
“The COVID-19 pandemic has shown us the importance of government and industry collaboration to protect citizens by ensuring the availability of critical diagnostic tests, therapies and vaccines,” said Casper. “This partnership enables us to expand our sterile fill finish network in the region while strengthening the Singapore government’s ability to respond quickly to future health crises.”
The new facility will initially include a high-speed sterile line approved for live virus filling – the first such large scale capability in Singapore – followed by an additional line for standard fill/finish. The facility will also have cleanroom capacity, labs, warehousing and offices to support production. Once operational in 2022, the facility could manufacture up to 30 million sterile doses per month and employ more than 300 people.