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An Isothermal Method to Amplify RNA from Bloodborne Viruses

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43AI170123-01A1
Agency Tracking Number: R43AI170123
Amount: $290,196.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA22-176
Timeline
Solicitation Year: 2022
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-08-01
Award End Date (Contract End Date): 2024-07-31
Small Business Information
2501 Earl Rudder Freeway South
College Station, TX 77845-6023
United States
DUNS: 184758308
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 KARL GORZELNIK
 (979) 764-2200
 karl.gorzelnik@lynntech.com
Business Contact
 SHAWN RHODES
Phone: (979) 764-2200
Email: contract@lynntech.com
Research Institution
N/A
Abstract

PROJECT SUMMARY
Bloodborne RNA viruses, in particular HIV-1 and hepatitis C, are a major public health burden. The diagnostic
gold standard for these viruses is the use of RT-qPCR, which is expensive for use in developing countries.
Traditional tests for HIV-1 also cannot be used to assess antiretroviral efficacy, as RT-qPCR could pick up
integrated DNA and serological tests can detect antigens chromosomally expressed from integrated DNA. We
propose the development of a diagnostic assay that will amplify and detect the RNA of bloodborne RNA viruses
via a unique RNA amplification process. By developing a method to enrich viral RNAs over eukaryotic or
bacterial RNAs we can lower the limit of detection and potentially reduce the level of false positives and negatives
observed when using RT-based diagnostics. As this method is specific for viral RNA in general, it can be used
for other human ssRNA viral pathogens, such as Zika or Dengue. The broader impact/commercial potential of
this Small Business Innovation Research (SBIR) Phase I project will be the development of a new step in viral
RNA detection, usable for detecting the five bloodborne viruses we propose here, but also other ssRNA viruses.
By using an isothermal approach to amplify viral RNA our device will eliminate the need for expensive
equipment, which will increase access to testing. In the wake of the SARS-CoV-2 pandemic, the general
public learned that Point-of-Care (POC) tests for antibodies or antigens do not detect low levels of viral infections.
We propose to develop a test that will selectively amplify viral RNAs, which will bring the sensitivity of nucleic
acid amplification to POC providers. The proposed work will validate the specificity of the enzyme toward viral
RNAs, develop a system to extract and detect these RNAs, and lower the detection limit for POC diagnostics.

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

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