You are here

Urine Diagnostics for Aspergillosis

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R42AI115866-02A1
Agency Tracking Number: R42AI115866
Amount: $1,844,235.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: NIAID
Solicitation Number: PA16-303
Timeline
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-07-18
Award End Date (Contract End Date): 2019-06-30
Small Business Information
1450 S ROLLING RD
Halethorpe, MD 21227-3863
United States
DUNS: 079332340
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: No
Principal Investigator
 KIEREN MARR
 (703) 851-6757
 kmarr4@jhmi.edu
Business Contact
 KIEREN MARR
Phone: (443) 742-0250
Email: kierenmarr@mycomedtechnologies.com
Research Institution
 ONL THERAPEUTICS, INC.
 
1600 HURON PKWY
ANN ARBOR, MI 48109
United States

 Domestic Nonprofit Research Organization
Abstract

Invasive aspergillosisIAcontinues to cause morbidity and death in medically immune
compromised patientslargely because we lack sensitive diagnostic tests that are easy to
use during high risk periodsWe discovered that fungal galactofuranose containing
antigens are excreted in urine of infected animals and peopleusing a novel monoclonal
antibodymAbIn a phase I STTRwe engineered a lateral flow deviceLFDcalled
AspUTestand performance was tested using urine samples obtained from patients with
suspected and confirmed IAResults showed rtsensitivity and specificitymeeting
predefined metrics for continued developmentThis Phase II application is designed to
meet the following Specific AimsTo optimize production of the AspUTest deviceTo
determine performance characteristics of AspUTest as an aid to diagnose invasive
aspergillosis using batched samples obtained from patients with hematological
malignanciesandTo validate and test the performance of AspUTest in clinical
microbiology laboratoriesMeeting these aims will enable submission for FDA clearance
of AspUTestmarking an important advance towards decreasing IA morbidity with
expanded availability of a low costeasy to use urine diagnostic

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

US Flag An Official Website of the United States Government