FDA clears Immunetics' ELISA for Lyme disease:
This article was originally published in Clinica
Executive Summary
Immunetics has gained US FDA 510(k) clearance to market its ELISA kit for Lyme disease. The C6 Borrelia burgdorferi test kit is based on a peptide, termed C6, which has been shown to be a highly accurate marker for the disease, says the Cambridge, Massachusetts firm. Studies have also revealed that the test substantially reduces the false negative and false positive results associated with current screening tests, claims Immunetics. Significantly, it does not yield false positive results on individuals vaccinated with GlaxoSmithKline Biologicals' Lymerix vaccine, the company adds.