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DiaSorin Submits Lyme Disease Test for FDA Approval

NEW YORK – DiaSorin on Thursday said it has submitted for US Food and Drug Administration approval an immunoassay for the early identification of Lyme disease.

The Saluggia, Italy-based firm said the submission was made last month.

The Liaison LymeDetect test incorporates three chemiluminescent assays for the detection of IgG, IgM, and T-cell mediated responses to Borrelia burgdorferi infections. It is used in conjunction with clinical signs and symptoms of Lyme disease.

The test, which DiaSorin developed in partnership with Qiagen, leverages that firm's QuantiFeron interferon-gamma release assay (IGRA) technology for use with DiaSorin's Liaison analyzers. The partnership also included the development of the Liaison QuantiFeron-TB Gold Plus Test for the detection of latent tuberculosis infections.

DiaSorin noted that Lyme disease, or borreliosis, is the most common vector-borne disease in the US, and about 476,000 patients are treated for the disease each year. Early symptoms can include fever, headache, fatigue, and an expanding rash that often forms a bull's-eye pattern, and untreated Lyme can lead to the development of arthritis with severe joint pain, neurological symptoms, cardiac inflammation, and irregular heartbeat.

DiaSorin Chief Commercial Officer Chen Even said in a statement that the Liaison LymeDetect assay will enhance the firm's immunodiagnostic offerings in the US market.