SBIR-STTR Award

Antiretroviral therapy (ART) reduces mortality and morbidity in HIV infected individuals but specific HIV mutations DRMs are associated with resistance. It is now known that certain DRMs can contribute to virological failure even at very low concentrations but standard tests are inadequately sensitive to detect these minor variants. Methods to detect minor variants that contribute to HIV virological failure are needed. In Phase I Aldatu expanded the capabilities of its core PANDAA technology to develop ExPAND which uniquely enables real time PCR for drug resistance detection in HIV and further has enhanced sensitivity specificity and selectivity performance for optimized and quantitative detection of HIV minor variants ExPAND reagents assays were validated using clinical isolates. In Phase II Aldatu will develop and manufacture a validated product for HIV minor variant detection. DR HIV ExPAND assays will be multiplexed into HIV drug class modules Aim after which Aldatu will work with CMO partners to optimize and manufacture qDR HIV kits under GMP conditions which will be extensively validated in house. Aim internal quality systems implementation and automated analysis interpretation software development for qDR HIV will be concurrent with product development work qDR HIV kit end user utility and ease of use will be evaluated at multiple partner sites Aim

Antiretroviral therapy ART reduces mortality and morbidity in HIV infected individuals but specific HIV mutations DRMs are associated with resistance. It is now known that certain DRMs can contribute to virological failure even at very low concentrations but standard tests are inadequately sensitive to detect these minor variants. Methods to detect minor variants that contribute to HIV virological failure are needed. In Phase I Aldatu expanded the capabilities of its core PANDAA technology to develop ExPAND which uniquely enables real time PCR for drug resistance detection in HIV and further has enhanced sensitivity specificity and selectivity performance for optimized and quantitative detection of HIV minor variants ExPAND reagents assays were validated using clinical isolates. In Phase II Aldatu will develop and manufacture a validated product for HIV minor variant detection. DR HIV ExPAND assays will be multiplexed into HIV drug class modules Aim after which Aldatu will work with CMO partners to optimize and manufacture qDR HIV kits under GMP conditions which will be extensively validated in house. Aim internal quality systems implementation and automated analysis interpretation software development for qDR HIV will be concurrent with product development work qDR HIV kit end user utility and ease of use will be evaluated at multiple partner sites Aim