NEW YORK – DiaSorin said Monday it secured CE marking for an immunoassay for the bacteria that cause Legionnaires' disease.
The Saluggia, Italy-based firm's Liaison Legionalla Urinary Antigen Immunodiagnostic Assay provides high-throughput qualitative detection of Legionella antigens LPS and PAL to aid the identification of Legionella pneumophila and Legionella longbeachae and targeted antimicrobial treatment. It is designed for use on the company's highly automated Liaison CLIA analyzers, with results in 35 minutes.
The firm noted that Legionella infections are a common cause of community-acquired pneumonia requiring hospitalization, and misdiagnosis can rapidly increase mortality risk, especially among immunosuppressed patients.
"The launch of this new assay confirms our ability to position DiaSorin as a specialty player, able to provide innovative solutions with a high medical value," DiaSorin Chief Commercial Officer Chen Even said in a statement. "We are confident that our new assay will strongly contribute in discriminating etiological factors in severe atypical pneumonia."