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ID-FISH Technology has received FDA clearance for its Lyme immunoblot diagnostic kits (iDart Lyme IgM and IgG ImmunoBlot Kits), showing high sensitivity and specificity versus standard methods. Its malaria FISH assays received FDA approval in 2017. Extensive clinical studies with leading reference labs (IGeneX) and the Bay Area Lyme Foundation confirm robust diagnostic accuracy for tick-borne diseases[6][2][3].
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