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Multiplex Lyme Disease Diagnostic

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43AI078570-01
Agency Tracking Number: AI078570
Amount: $100,001.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: N/A
Solicitation Number: PHS2007-2
Timeline
Solicitation Year: 2008
Award Year: 2008
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
AGAVE BIOSYSTEMS BOX 80010
AUSTIN, TX 78708
United States
DUNS: 022552900
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: Yes
Principal Investigator
 () -
Business Contact
Phone: (512) 656-6200
Email: nsalazar@agavebio.com
Research Institution
N/A
Abstract

DESCRIPTION (provided by investigator): Lyme disease, caused by the gram-negative spirochete Borrelia burgdorferi and transmitted by Ixodid tick species, is the leading vector-borne infectious disease in the United States, with a steady rise in the number
of cases reported each year. The most common Lyme disease symptom, the classic bull's-eye rash (erythema migrans or EM rash) in endemic areas, can indicate the need for immediate treatment without accompanying diagnostic testing. However, 3-10% of Lyme dis
ease cases proceed to less well diagnosed secondary symptoms without presentation or recognition of the EM rash. Current diagnostic testing consists of a two-tier system, as recommended by the Centers for Disease Control and Prevention. The first tier test
is an enzyme-linked immunosorbent assay (ELISA); the second tier consists of immunoblot (IB) analysis. The inherent flaw of the most commonly used first tier ELISA test, using whole cell sonicate (WCS), is its lack of specificity to B. burgdorferi antigen
s, yielding a high false positive rate. Additionally, the second-tier IB is costly, time-consuming, and technically challenging. As a result, recent efforts have focused on developing a single tier test format by increasing the specificity of the ELISA thr
ough the use of single or combinations of recombinant and peptide antigens. Although more than 70 serological Lyme disease tests have been developed and approved by the FDA, none has succeeded in replacing the WCS ELISA and the two-tier testing format, due
to similar levels of false positives and/or additional false negatives due to insufficient antigen presentation. Agave BioSystems has developed a wide range of multiplex microsphere assays, capable of simultaneously and quantitatively detecting individual
serum antibody responses to a panel of antigens. This technology enables high throughput evaluation of serum responses to individual antigens and combinations of antigens and has been validated against ELISA and IB results. Therefore, Agave BioSystems pro
poses to develop a Borrelia burgdorferi microsphere assay capable of replacing the Lyme disease two-tier test format. The microsphere assay will maintain the requisite level of sensitivity, while providing a significant improvement in specificity over the
WCS ELISA and broader antigen coverage compared to peptide and recombinant antigen ELISA assays. In the Phase II, a multiplex assay will be developed that allows quantifiable serum antibody response to over ten different antigens within a single multiplex
assay. PUBLIC HEALTH RELEVANCE: Lyme disease is the leading vector-borne infectious disease in the United States, with a steady rise in the number of cases reported each year. Current diagnostic testing consists of a two-tier system which is time-consuming
, technically challenging, and has a high false positive rate. Agave BioSystems proposes to develop a Borrelia burgdorferi microsphere assay capable of replacing the Lyme disease two-tier test format. This microsphere assay will maintain the requisite leve
l of sensitivity, while providing a significant improvement in specificity over the WCS ELISA and broader antigen coverage compared to peptide and recombinant antigen ELISA assays.

* Information listed above is at the time of submission. *

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