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Validation of a Diagnostic Test for Borrelia miyamotoi

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41AI134497-01
Agency Tracking Number: R41AI134497
Amount: $574,217.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIAID
Solicitation Number: PA16-303
Timeline
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-08-14
Award End Date (Contract End Date): 2019-07-31
Small Business Information
300 GEORGE ST STE 309
New Haven, CT 06511-6662
United States
DUNS: 142406110
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 MICHEL LEDIZET
 (203) 503-0383
 mledizet@l2dx.com
Business Contact
 MARTIN MATTESSICH
Phone: (203) 393-9439
Email: mmattessich@l2dx.com
Research Institution
 UNIV OF MASSACHUSETTS MED SCH WORCESTER
 
55 LAKE AVENUE NORTH
WORCESTER, MA 01655-0002
United States

 Nonprofit college or university
Abstract

ABSTRACT
Borrelia miyamotoi is a tick transmitted spirochete recently shown to cause infection and disease in the United
StatesEurope and AsiaA member of the relapsing fever group of Borreliathis pathogen has been proven to
cause most commonly a nonspecificflu like illness with feverfatiguemyalgiaand headacheDisease can be
particularly severe and involve the central nervous system in immunocompromised patientsThe true extent of
disease due to this bacterium is difficult to assess because of the lack of a fully validated diagnostic assayConverselydevelopment of a clinically useful test is difficult because of the lack of a large cohort of clinically
well characterized patients infected with BmiyamotoiWe have access to two populations of well characterized
patients from which we can identify cases of active diseaseOur goal over Phases I and II of this project is to
assemble a collection of up toserum samples from patients known to have been exposed to and or infected
with BmiyamotoiThe first cohort of patients consists of individuals who have been bitten by ticks and who
have submitted these ticks for analysis to our collaborator DrRichIf the tick is found to be infected with Borrelia
miyamotoiwe will contact the patient and obtain blood and serum samplesThe second group of patients will
consist of individuals who consulted their healthcare professional with symptoms of febrile illness in the spring
and summer and who are suspected of having a tickborne illnessWe have developed a prototype multiplexed
serological assay for Borrelia miyamotoi infection based on seven published or proprietary antigensWe propose
to validate this assay by analyzing serum samples from both cohorts of infected patientsStatistical methods
will be used to identify the most useful diagnostic antigens and to develop an algorithm optimizing the sensitivity
and specificity of the assayPatients infected with Borrelia miyamotoi will be identified by a PCR reaction that
is positive for this pathogenor by evidence of seroconversion between acute and convalescent samplesA
statistical approach will allow us to identify those antigens that are diagnostically informative and to develop
validated criteria to correctly diagnose Bmiyamotoi infection using our multiplex assay

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

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