National Institutes of Health Awards Grant for More Accurate Lyme Disease Test

Cambridge Based Immunetics, Inc. Receives Support for New, Accurate Test That Eliminates False Positives

Immunetics, Inc. was awarded a Phase I SBIR grant by the National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health, to support a clinical trial comparison of its new Lyme disease test with the two-tier protocol currently used for Lyme diagnosis.  Immunetics’ test was approved last year by the FDA for use as a first-tier screening test.  This is the first Lyme disease test to make use of a peptide antigen termed “C6”, which screens out false positive results common to other tests for Lyme disease.  Earlier clinical trials have shown the C6 peptide to be a highly sensitive and specific marker for exposure to B. burgdorferi, the spirochetal agent of Lyme disease, in both U.S. and European patients.  The C6 test also eliminates false positive results which may be due to other conditions or to vaccination with Lymerix®, the vaccine from GlaxoSmithKline.

 Immunetics will join forces with researchers at Tulane University and other academic institutions under the new grant.  In the clinical trial, the sensitivity of the C6 Lyme test will be measured in groups of human patients followed over time, and in nonhuman primates which serve as an experimental model for human Lyme disease.

 “We have already demonstrated the superb sensitivity and specificity of the C6 test as a first tier screening test” said Dr. Andrew Levin, Immunetics’ founder and Chief Executive Officer.  “Our goal in this carefully controlled study, using a group of the world’s most well-characterized specimens from Lyme disease patients and primate subjects, is to determine whether the C6 test can replace the current two-tier protocol - a combination of screening and confirmatory testing for Lyme disease which is a time-consuming, expensive and still imperfect approach.  We believe that patients and health care practitioners will benefit from a single test that is more accurate, cost effective, faster and simpler than the two tier method.  We anticipate that the results of the study which is now underway will fully support the potential of the C6 test to supercede this method.  We are very pleased and honored that the National Institute of Allergy and Infectious Diseases has chosen to support this significant clinical trial which represents a key step on that path, and likewise to have the opportunity to collaborate on this grant with our colleagues at Tulane University and other leading Lyme disease research centers, thanks to whom the study specimens will be available to us.” 

 The C6 ELISA kit is available in the U.S. directly from Immunetics.  Physicians can locate the nearest laboratory offering the C6 test by calling Immunetics at 800-227-4765.

 Immunetics offers state-of-the-art assay technology for infectious disease research and diagnosis, and for over ten 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.