Development of Molecular Diagnostic Test For Early Onset of Lyme Disease

DESCRIPTION provided by applicant There is no validated assay to reliably detect the early onset of the Lyme disease infection at the time when antibiotic therapy has the best chance of a cure without sequelae Diagnosis is often difficult because most symptoms are often nebulous with the telltale andquot bulls eyeandquot rash only appearing and clearly recognizable in approximately half of cases The standard types of infectious diagnostic tests both culture and serology require andgt weeks for a positive result after the onset of infection with Lyme disease This introduces a significant delay in treatment While PCR for B burgdorferi DNA in the blood has potential for a rapid accurate result past tests have not had sufficient sensitivity because f few bacteria and low copy numbers of DNA in the blood We have developed an approach that andquot enlarges the targetandquot substantially increasing the sensitivity of PCR for B burgdorferi Our preliminary data show that we can accomplish this by obtaining a larger sample of blood than usual X increase in sensitivity selectively multiplying the target by using Borrelia directed primers prior to PCR X increase and probing for the B burgdorferi on a multi loci PCR platform X increase To assure reliability and acceptance of a new test based on this approach we have formally consulted with the FDA from the beginning and obtained a pre IDE approval with guidance as to what we need to do for a final cleared test In this proposal we will test blood samples from eventually confirmed Lyme cases with our PCR based assay at the time of patient presents to prove that it can detect the B burgdorferi infection earlier and with greater sensitivity specificity than two tiered serology taken at the same time Specificity will be assured by testing endemic area controls without Lyme disease If successful as our Preliminary and published data suggest we will follow with a Phase II proposal that analyzes greater number of Lyme disease and control samples to meet the full number for FDA clearance Our goal is deliver a functional diagnostic assay for Early Onset Lyme Disease that has superior sensitivity and specificity compared to two tiered serology The test will permit immediate diagnosis well before seroconversion or cultures become positive so treatment can be started right away PUBLIC HEALTH RELEVANCE The ability to accurately identify Lyme disease in the susceptible people will be important in management strategy of patients exposed or bitten by ticks It will help reduce rising costs to the patient and the public health system