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DiaSorin Obtains CE Mark for 10-Minute SARS-CoV-2 Antibody Test

NEW YORK ─ DiaSorin said on Tuesday that it has obtained CE marking for its Liaison IQ immunodiagnostic point-of-care reader and Liaison Quick Detect COVID TrimericS Ab test and has launched them in countries that accept the designation.

Saluggia, Italy-based DiaSorin said that its Liaison Quick Detect COVID TrimericS Ab test is its first available on the Liaison IQ reader. The test uses capillary blood from a fingerstick to detect specific IgG antibodies against the SARS-CoV-2 spike protein in 10 minutes, the firm said.

It developed the platform and test with Sarasota, Florida-based Lumos Diagnostics.

CE marking of "Liaison IQ and its first test provide us access to the growing lateral flow business in the point-of-care market, allowing DiaSorin to follow the decentralization trend of diagnostics," Carlo Rosa, CEO of DiaSorin, said in a statement.

DiaSorin said it intends to access the market by starting with a program in Italy that targets pharmacies through agreements with distributors to obtain placements for the platform and antibody assay.

DiaSorin added that its test had a specificity of 97.5 percent and a sensitivity of 98.0 percent in clinical studies, and it anticipates applying to the US Food and Drug Administration for Emergency Use Authorization and CLIA waiver for the test and reader.

The point-of-care test uses the full-length trimeric form of the SARS-CoV-2 spike protein, which is also part of DiaSorin's recently launched Liaison SARS-CoV-2 TrimericS IgG chemiluminescent immunoassay.

Last November, the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority announced that it had awarded $820,000 to DiaSorin to develop that test.

DiaSorin and Lumos plan to obtain CE marking and apply for FDA EUA in the second quarter of this year for a SARS-CoV-2 antigen test they are developing.