# Development of Molecular Diagnostic Test for Early Onset of Lyme disease

> **NIH NIH R44** · BIOSCIENCE DEVELOPMENT, INC. · 2020 · $998,043

## Abstract

Project Summary/Abstract
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 “bulls-eye” rash only appearing and
clearly recognizable in approximately half of cases.
The standard types of infectious diagnostic tests – both culture and serology – require >3 weeks for a
positive result after the onset of infection with Lyme disease and serology only indicates exposure but
not active infection. 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 of too few bacteria and low copy numbers of DNA in the blood. We have
developed an approach that “enlarges the targetability”, by 160,000 fold, thereby increasing the
sensitivity of PCR test for B. burgdorferi. Our data show we are successfully accomplishing this by:
using a larger amount of blood to start (10 fold); then selectively multiplying the target by using
Borrelia-directed primers prior to PCR (2000 fold); and then probing the product for the B. burgdorferi
on a multi-loci PCR platform (8 fold).
To assure reliability and acceptance of a new test based on this approach, we formally consulted with
the FDA from the beginning. We obtained a Qsub (pre-IDE) approval with guidance as to what we
need for a cleared test. During this proposal we will continue to test blood samples (from eventually
confirmed Lyme cases and control subjects) with our PCR-based assay at the time the patient
presents to the doctor in order to prove the assay can detect the B. burgdorferi infection, earlier and
with greater sensitivity, than the FDA benchmark of two-tiered serology taken at the same time. If
successful, at the number agreed on with the FDA, this Phase II should result in a test that has FDA
clearance.
Our goal is deliver a functional and affordable 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.

## Key facts

- **NIH application ID:** 9858215
- **Project number:** 5R44AI114009-04
- **Recipient organization:** BIOSCIENCE DEVELOPMENT, INC.
- **Principal Investigator:** Barbara A. Body
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $998,043
- **Award type:** 5
- **Project period:** 2015-02-07 → 2024-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9858215

## Citation

> US National Institutes of Health, RePORTER application 9858215, Development of Molecular Diagnostic Test for Early Onset of Lyme disease (5R44AI114009-04). Retrieved via AI Analytics 2026-06-23 from https://api.ai-analytics.org/grant/nih/9858215. Licensed CC0.

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