Novel Diagnostic Sequencing System for HIV Resistance Testing

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 2R44AI074232-03A1
Agency Tracking Number: R44AI074232
Amount: $2,952,955.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA10-123
Solicitation Year: 2011
Award Year: 2011
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
34 Bear Hill Rd., Waltham, MA, -
DUNS: 170777770
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (781) 354-3354
Business Contact
Phone: (781) 466-8050
Research Institution
DESCRIPTION (provided by applicant): As of 2008 the CDC estimated that there were approximately 1.1 million persons in the U.S. infected with HIV- 1 and about 56,000 new cases are diagnosed each year. During the mid-to-late 1990s, advances in treatment slowed the progression of HIV to AIDS and related deaths. Unfortunately, the treatment often leads to the emergence of drug resistant mutants of HIV-1. The knowledge of the HIV-1 variants present in a patient is extremely important to effectively plan diseasemanagement. It is estimated that about 10% of HIV-1 infections in the US is caused by drug resistant HIV-1 variants and current guidelines recommend HIV-1 resistance genotyping before therapy and to monitor therapy effectiveness. However, current tests that rely on conventional DNA sequencing methods do not detect low-levels (lt 20%) of drug-resistant strains and therefore may not provide the necessary diagnostic information for effective treatments. The goal of this proposal is to develop a highly sensitive comprehensive and cost-effective system for HIV-1 resistance genotyping based on IBS' high-speed massively parallel DNA sequencing system (RESIQ ). IBS' sequencing-by-synthesis system is based on the use of cleavable fluorescent nucleotides with reversible terminator technology. These features enable efficient removal of fluorescent signals and sequencing of repeats. During Phase II, a prototype sequencing instrument prototype will be constructed and extensive validation of the prototype using validatedclinical samples will be performed. Dr. Daniel Kuritzkes, an expert in the HIV-1 treatment and resistance will serve as a consultant for this project. Successful accomplishment of the Phase II project will result in the development of highly effective andcomprehensive RESIQ system for rapid, sensitive cost-effective HIV-1 drug resistance genotyping. 0 PUBLIC HEALTH RELEVANCE: The proposed research is aimed at the development of a high-sensitivity sensitive, cost-effective HIV-1 resistance genotyping system which is powered by massively parallel DNA sequencing by synthesis (SBS). Compared to current technology based on DNA sequencing, the Intelligent Bio-Systems' approach will be able to rapidly detect low levels (1-20%) of multiple drug resistant HIV-1 variants in patient's plasma. The major application of the SBS-GEN HIV-1 genotyping product will be the detection of the presence, at levels 1-20%, of the viral population with drug-resistance. The SBS-GEN HIV-1 genotyping system will be used in patients undergoing anti-retroviral drug therapy to monitor its effectiveness, changing the treatment regimen, or patients newly diagnosed with HIV-1 infection. 0

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

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