A Rapid Portable HIV Detection and Monitoring System for Low Resource Settings

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44AI089389-05
Agency Tracking Number: R44AI089389
Amount: $2,809,346.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA12-088
Solicitation Year: 2013
Award Year: 2013
Award Start Date (Proposal Award Date): 2013-08-07
Award End Date (Contract End Date): 2016-07-31
Small Business Information
25 Cabernet Circle, Fairport, NY, 14450-4613
DUNS: 148233393
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (585) 425-4888
Business Contact
Phone: (585) 248-9598
Email: jgrover@thermalgradient.com
Research Institution
DESCRIPTION provided by applicant Rapid Portable HIV Detection and Monitoring System The long term objectives of this project are Develop a prototype of a rapid portable instrument for detecting and measuring the amount of Human Immunodeficiency Viruses HIVandapos s in samples of patient blood particularly in low resource settings Carry out a pilot study to establish the effectiveness and comparative performance of the instrument against an established reference system The aim is to provide clinicians tools to diagnose and monitor HIV that exist in resource abundant settings but are not readily available in low resource settings In particular the instrument system will provide clinicians with detection methods that could be helpful in identifying acute HIV early diagnosis of infection in pregnant women and infants monitoring viral load following treatment and monitoring for the emergence of antiretroviral resistance Viral load monitoring of patients on antiretrovirals is a good example of the difference in treatment between resource abundant and low resource settings Routinely done in the former because of the threat to patients and community should they develop a drug resistant strain of HIV millions of recipients of antiretroviral therapy currently are not being monitored de to its cost and complexity These aims are congruent with those parts of the mission of DAIDS andquot to bring an end to the HIV AIDS epidemic by supporting the advancement of therapies for HIV infection and its complications andquot This project will achieve its stated goals by completing the design of a compact portable system based on the ultra fast Thermal Gradient real time PCR and nucleic acid sample preparation technologies developed in the original R grant They will be combined in an integrated test cartridge capable of carrying out a viral load test in minutes and a multi color fluorescent imaging system will be developed to measure the real time PCR output simultaneously Finally the performance of the system instrument cartridge and assay will be validated first in internal tests using prepared blood samples and then a significant pilot study PUBLIC HEALTH RELEVANCE Rapid Portable HIV Detection and Monitoring System A rapid HIV POC diagnostic and monitoring device would facilitate diagnosis and monitoring of antiretroviral therapy in resource limited settings POC tests can make HIV testing accessible in areas with limited laboratory facilities and can provide immediate test results that are needed to make clinical decisions In particular easy to use HIV tests could transform the management of pediatric HIV AIDS in developing countries averting millions of infant deaths and help alleviate the threat to public health represented by the current practice of treating millions of HIV patient with antiretrovirals without monitoring their viral loads

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

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