ExPAND for Rapid, Sensitive, Cost-effective Detection of Drug-resistant HIV Minority Variants

Aldatu Biosciences, Inc., Watertown MA

Investigators

Abstract

Method for the Detection of Minority Populations of Drug Resistant HIV: The goal of this solicitation is to develop an assay to detect minor populations of resistant variants in blood specimens from HIV-infected individuals with HIV RNA viral loads above 1000 copies/ml. The test must detect resistant variants that comprise 1% or more of the virus population or quasispecies, and must detect mutations causing resistance to NNRTIs, NRTIs, PIs and INIs in all subtypes of HIV. Sensitivity for qualitative detection of the minor variant at 1% or more must be at least 95% and specificity at least 98%, but the method must also yield quantitative results, showing the percentage of each resistant variant in the overall quasispecies. The method must be appropriate for use in centralized clinical laboratories with a target turn-around-time of less than 1 week and an initial target cost of $100 or less.