Novel Viral Load Diagnostic for Resource-Limited Settings

DESCRIPTION (provided by applicant): The lack of affordable and practical HIV diagnostics, including assays to monitor HIV RNA levels ("viral load") has been identified as a major barrier to HIV care worldwide. An inexpensive, rugged and easy-to- use diagnostic able to measure viral load with rapid time-to-result would revolutionize HIV monitoring and infant diagnosis in the resource-scarce regions most impacted by HIV disease, helping to narrow the health care quality gap between the developed and developing world. In the awarded Phase I, BioScale, Inc. and Dr. William Rodriguez of Massachusetts General Hospital (MGH) teamed up to initiate development of an HIV viral load diagnostic suited for resource-limited settings, in response to SBIR-AT-NIAID, which called for the advancement of assays for infectious and immunological disease diagnosis on novel advanced technology platforms. We believe that the unique properties of BioScale's sensor system meet the rigorous needs of an HIV viral load diagnostic for point-of- care use in resource-poor settings: rapid, easy-to-use, automatable sample preparation, inexpensive, rugged with low-power consumption. We have successfully completed the specific aims in our Phase I program and plan to continue development and validation of a field-deployable HIV viral load diagnostic. The specific aims of our Phase II application are: 1. To evaluate the accuracy, threshold of detection and usability of a laboratory prototype instrument (alpha unit) and version 1.0 assay in clinical samples, in comparison to gold standard HIV viral load assays. 2. To develop a field deployable prototype instrument (beta unit), and 3. To evaluate the field deployable unit for accuracy, detection threshold and usability for infant HIV diagnosis and adult HIV viral load quantification. As with existing gold standard HIV viral detection methods, such as RT-PCR, BioScale's proposed assay has two distinct applications: quantitative measurement of HIV viral load in adults for disease monitoring; and qualitative infant diagnosis to determine the presence or absence of HIV infection in infants below 15 months of age. Both diagnostic assays are urgently needed in resource-limited settings. The lack of affordable and practical HIV diagnostics, including assays to monitor HIV RNA levels ("viral load") is a major barrier to HIV care worldwide. BioScale's proposed inexpensive, rugged and easy-to-use diagnostic for measuring viral load with rapid time- to-result would revolutionize HIV monitoring and infant diagnosis in the resource-scarce regions most impacted by HIV disease, helping to narrow the health care quality gap between the developed and developing world.