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IGeneX Gets New York State Approval for Tick-Borne Relapsing Fever Immunoblot Tests

NEW YORK – IGeneX, a maker of tick-borne disease tests, announced yesterday its immunoblot assays for tick-borne relapsing fever have been approved by the Division of Laboratories of the Department of Health of the State of New York. The assays are now immediately available to New York practitioners.

The Tick-Borne Relapsing Fever (TBRF) ImmunoBlots (IgM and IgG) detect antibodies to Borrelia species, including B. hermsii, B. miyamotoi, and B. turicatae.

Tick-borne relapsing fever is considered a "Lyme disease imitator," the firm noted in a statement. Like Lyme, which is thought to be caused by B. burgdorferi species, TBRF can result after a bite from an infected tick, and infection causes high fever, chills, and headache.

But, the TBRF infection can also produce a relapsing-remitting pattern of fevers, according to the US Centers for Disease Control and Prevention.

Jyotsna Shah, president of Milpitas, California-based IGeneX noted that the tests can also help patients who may have Lyme and TBRF Borrelia mixed infections. 

The firm said the tests have a specificity of approximately 99 percent for IgM and IgG based on a study performed on 212 well characterized samples, of which 50 were provided by the CDC. Additionally, the TBRF ImmunoBlots can detect the full spectrum of infection and disease, including early and active infections and late-stage disease.

IGeneX's Lyme disease assay for several species of B. burgdorferi received New York State approval last year.