ALDATU BIOSCIENCES INC — Department of Health and Human Services SBIR Phase II: NIAID

Description

Antiretroviral therapyARTreduces mortality and morbidity in HIV infected individualsbut specific HIV mutationsDRMsare associated with resistanceIt is now known that certain DRMs can contribute to virological failure even at very low concentrationsbut standard tests are inadequately sensitive to detect these minor variantsMethods to detect minor variants that contribute to HIV virological failure are neededIn Phase IAldatu expanded the capabilities of its core PANDAA technology to develop ExPANDwhich uniquely enables real time PCR for drug resistance detection in HIVand further has enhanced sensitivityspecificityand selectivity performance for optimized and quantitative detection of HIV minor variantsExPAND reagents assays were validated using clinical isolatesIn Phase IIAldatu will develop and manufacture a validated product for HIV minor variant detectionqDR HIVExPAND assays will be multiplexed into HIV drug class modulesAimafter which Aldatu will work with CMO partners to optimize and manufacture qDR HIV kits under GMP conditionswhich will be extensively validated in houseAiminternal quality systems implementation and automated analysis interpretation software development for qDR HIV will be concurrent with product development workqDR HIV kit end user utility and ease of use will be evaluated at multiple partner sitesAim