Skip to main content
Premium Trial:

Request an Annual Quote

DiaSorin SARS-CoV-2 Serology Kit Receives FDA Emergency Use Authorization, BARDA Funding

NEW YORK ─ DiaSorin said Saturday it has received US Food and Drug Administration Emergency Use Authorization for the Liaison SARS-CoV-2 S1/S2 IgG serology assay, which identifies the presence of IgG antibodies in people who have been infected with SARS-CoV-2.

Saluggia, Italy-based DiaSorin also said that it recently inked a contract with the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) to obtain funding to making the test available in the US. Financial terms of the contract were not disclosed.

DiaSorin said its high-throughput serological test was validated at Policlinico San Matteo in Pavia. The test will run on the company's Liaison XL automated chemiluminescence analyzer, which has a throughput of 170 patient samples per hour. Five thousand Liaison XL platforms are installed worldwide, including 600 in US hospital and commercial labs, the firm said.

The company added that it is scaling up production capacity in its main facility in Saluggia to manufacture several million Liaison SARS-CoV-2 tests over the next few months and distribute them worldwide.

"Widely distributed tests are needed immediately to quickly identify not only people who have an active infection but also those who have recovered," BARDA's Acting Director Gary Disbrow said in a statement. "This knowledge is particularly important for healthcare providers and other critical infrastructure personnel to return to work after any potential exposure to SARS-CoV-2."

DiaSorin Molecular had received an FDA EUA in March for its Simplexa COVID-19 Direct assay running on the firm's sample-to-answer Liason MDX real-time PCR instrument.