Agilent Technologies Inc. (NYSE: A) today announced the launch of the Agilent Dako SARS-CoV-2 IgG Enzyme-Linked Immunosorbent Assay (ELISA) kit intended for the qualitative detection of immunoglobulin G (IgG) antibodies to SARS-CoV-2 in human serum or plasma. The kit, which marks Agilent’s entrance into SARS-CoV-2 testing in the US, has completed the notification process to FDA in accordance with Section IV.D of FDA’s “Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)”. The assay is planned to be registered in other markets in 2021 including Canada, Europe, and selected Asia Pacific and Latin American countries.
The kit is a qualitative two-step indirect ELISA for the detection of human IgG antibodies to the SARS-CoV-2 S1 RBD protein. It is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. In Agilent’s clinical study, the SARS-CoV-2 IgG ELISA kit is a highly accurate immunoassay with 98.9% sensitivity and 98.8% specificity.
The ELISA kit includes consumables that meet the needs for small to medium-sized clinical labs to ensure easy and sustainable access to serology tests when the demands arise. By providing a kit that contains all the necessary reagents – including negative, positive, and cut-off controls – Agilent has developed a ready-to-use solution that enables labs to consistently execute dependable SARS-COV-2 serological testing.
"Implementing new technologies into clinical workflows can be daunting, and the pressures of the SARS-CoV-2 pandemic have further exacerbated the need for technology solutions that are quick and easy to implement,” said Sam Raha, president of Agilent’s Diagnostics and Genomics Group. “Providing turnkey solutions eases the implementation and validation resources for clinical labs, which helps lower the barrier to the adoption of additional SARS-CoV-2 tests.”
With its recent acquisition of BioTek, Agilent has further strengthened its position as a comprehensive provider of the hardware, software, assays, and support that labs need to seamlessly perform serological assays. Agilent has developed the SARS-CoV-2 IgG ELISA assay using BioTek microplate liquid handlers and plate readers.
Agilent is a premier provider of high-quality antibodies and assay solutions for many top IVD manufacturers globally. Leveraging this expertise, Agilent is introducing a high-performance kit as its initial entry into SARS-CoV-2 serological testing.
Agilent is committed to supporting its customers throughout the world by providing solutions for detecting SARS-CoV-2. This is the first of multiple tests that are planned to support the management of this disease in patients who have been exposed to COVID-19. In addition to this immunoassay test, Agilent is developing a quantitative RT-PCR SARS-CoV-2 test, which will be CE marked in Europe, as well as registered in additional countries throughout the world.
This news release contains forward-looking statements as defined in the Securities Exchange Act of 1934 and is subject to the safe harbors created therein. The forward-looking statements contained herein include, but are not limited to, information regarding expansion into other markets, regulatory authorizations, and future growth plans. These forward-looking statements involve risks and uncertainties that could cause Agilent’s results to differ materially from management’s current expectations. Such risks and uncertainties include, but are not limited to, unforeseen changes in the strength of Agilent’s customers’ businesses; unforeseen changes in the demand for current and new products, technologies, and services; unforeseen changes in the currency markets; customer purchasing decisions and timing, and the risk that Agilent is not able to realize the savings expected from integration and restructuring activities. In addition, other risks that Agilent faces in running its operations include the ability to execute successfully through business cycles; the ability to meet and achieve the benefits of its cost-reduction goals and otherwise successfully adapt its cost structures to continuing changes in business conditions; ongoing competitive, pricing and gross-margin pressures; the risk that its cost-cutting initiatives will impair its ability to develop products and remain competitive and to operate effectively; the impact of geopolitical uncertainties and global economic conditions on its operations, its markets and its ability to conduct business; the ability to improve asset performance to adapt to changes in demand; the ability of its supply chain to adapt to changes in demand; the ability to successfully introduce new products at the right time, price and mix; the ability of Agilent to successfully integrate recent acquisitions; the ability of Agilent to successfully comply with certain complex regulations; the adverse impacts of and risks posed by the COVID-19 pandemic and other risks detailed in Agilent’s filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the fiscal year ended October 31, 2020. Forward-looking statements are based on the beliefs and assumptions of Agilent’s management and on currently available information. Agilent undertakes no responsibility to publicly update or revise any forward-looking statement.
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