Immunetics receives FDA approval for more accurate Lyme test without vaccine cross-reactivity

Immunetics, Inc. is pleased to announce that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its C6 B. burgdorferi (Lyme) ELISA Kit.  The kit is for in vitro diagnostic use in the detection of human antibodies specific to B. burgdorferi, the agent of Lyme disease.  The new test is based on a specific peptide termed “C6” which has been shown to be a highly accurate marker for Lyme disease.  The test has been shown to dramatically reduce the number of false positive results, while at the same time increasing the sensitivity of detection of Lyme disease in both early and late stages, in comparison with current screening tests.  These advantages will enable physicians to diagnose or rule out the disease more quickly, with less re-testing.  As an added benefit, the C6 test detects infection with European strains of the Lyme disease pathogen, and will thus serve an international market. 

Significantly, the test does not yield false positive results on individuals vaccinated with the Lymerix® vaccine (recombinant OspA vaccine against Lyme disease, manufactured by GlaxoSmithKline Biologicals).  False positive results are typically obtained with other screening tests on the market. 

“We believe that the availability of the C6 test will make a significant and positive impact on the accuracy of Lyme disease diagnosis today”, said Dr. Andrew Levin, Immunetics’ founder and Chief Executive Officer.  “This test represents the culmination of several years of work by our scientists in collaboration with our academic colleagues.  We have shown through our clinical trials that the C6 test substantially eliminates the large number of false positive and false negative results which in sum have led to the inaccurate and costly misdiagnosis of Lyme disease.  Patients and physicians will both benefit from a more definitive test.  We are pleased to report that we can now deliver it.” 

Immunetics offers state-of-the-art assay technology for infectious disease research and diagnosis, and for over 10 years has been a leading innovator of tests for Lyme and other tick-borne diseases.  The Company produces and markets a range of infectious disease immunoassay kits and instruments.