IMMUNETICS, INC. — Department of Health and Human Services SBIR Phase II: NIAID

Description

DESCRIPTION provided by applicant Lyme disease is the most prevalent vector borne disease in the U S with about cases per year reported by CDC and a range now covering states Early diagnosis and treatment of Lyme disease is important to prevent the disease from progressing to a systemic infection characterized by chronic arthritis carditis or neurological disorders Where a patient does not truly have Lyme disease an accurate negative test result would be valuable in promptly directing a physician to seek other causes of illness and hopefully minimize unnecessary antibiotic therapy No Lyme rapid test suitable for physicianandapos s office use is commercially available and the current laboratory based two tier Lyme testing algorithm ELISA followed by Western blot suffers from high cost slow time to results days subjective interpretation and low sensitivity for early infections Accordingly there s a critical need for a rapid Lyme diagnostic test with improved performance The overall objective of the proposed project is the development and clinical validation of a rapid point of care test for Lyme disease that will for the first time make accurate Lyme testing accessible to any physicianandapos s office In Phase I we have developed a prototype Lyme rapid test with minute total turnaround time which exhibited andgt specificity and sensitivity equal to or greater than that of FDA cleared ELISA tests in both early and late stage infections In particular the Lyme C C rapid test provided high detection sensitivity for very early Lyme infections andlt week post onset of erythema migrans rash significantly better than several FDA cleared Lyme ELISA tests The rapid Lyme test is based on three innovative components novel detection chemistry with ELISA equivalent sensitivity a combination of C and C synthetic peptide antigens yielding high sensitivity for early infections and an immunoassay format that overcomes previous limitations of rapid tests for sensitive antibody detection In Phase II we will optimize and validate the rapid test for both whole blood and serum plasma samples to enable its use as a CLIA waived test in a physicianandapos s office environment Performance of the rapid test will be compared to that of the current two tier Lyme testing algorithm in prospective and retrospective clinical studies to support a k submission for FDA clearance Based on the high sensitivity and specificity which we expect to demonstrate in these studies we will propose an FDA claim that the Lyme rapid test may substitute for one or both steps of the two tier protocol The Lyme C C rapid test will be the first commercial implementation of our novel rapid test technology and will for the first time enable accurate same day Lyme disease diagnostic results which could lead to a basic paradigm shift in the standard protocol for Lyme testing PUBLIC HEALTH RELEVANCE Each year over people in the U S become infected with Lyme disease LD which is transmitted by tick bites If LD is not detected and treated at an early stage it may lead to serious health problems including arthritis heart disease or nerve disorders Current LD lab tests require a day wait for results which means that many physicians may prescribe antibiotics for patients with Lyme like symptoms without having lab test results to support the diagnosis We propose to develop a min point of care rapid test for Lyme disease that will provide highly sensitive and accurate test results that doctors can use to more quickly diagnose Lyme disease and prescribe the best treatment