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IGeneX Lyme Disease Tests Win NY State Approval

NEW YORK (360Dx) — IGeneX said today that the New York State Department of Health has approved the company's Lyme disease detection assays.

The approval allows IGeneX to make the assays available to New York residents.

Launched in late 2017, Lyme ImmunoBlot IgM and IgG are designed to detect several species of Borrelia burgdorferi, the tick-borne parasite primarily responsible for all Lyme disease cases in the US, as well as other Borrelia species including B. mayonii, B. spielmanii, B. californiensis, B. valaisiana, B. afzelii, and B. garinii. IGeneX said that the tests can detect early, active, and late-stage disease with high sensitivity and specificity.

"The Lyme ImmunoBlot is intentionally more inclusive for Borrelia burgdorferi sensu lato than the currently available Western blots because we now know that other species … all cause disease in the US," IGeneX Jyotsna Shah said in a statement. "With the increase of international travel in the last 10 years, people can get infected at home, other parts of the US, or Europe depending on their lifestyle. Thus, it is important to have available a test that can detect the infection irrespective of where it was acquired."