NEXT-GEN Oral test for monitoring HIV/AIDS in Point-of-Care

Period of Performance: 09/01/2017 - 08/31/2018

$374K

Phase 2 SBIR

Recipient Firm

Gaia Medical Institute, LLC
LA JOLLA, CA 92037
Principal Investigator
Principal Investigator
Principal Investigator

Abstract

? DESCRIPTION (provided by applicant): NEXT-GEN Oral test for monitoring HIV/AIDS in Point-of-Care The ultimate goal of this project is to develop a new point-of-care test for acute HIV screening and therapeutic monitoring of HIV/AIDS in Point-of-care. The commercial product will be a compact sample-to-answer system with disposable cartridges, capable of achieving CLIA waiver. The test will be rapid (<20 minutes) and inexpensive (<$2). The test will measure HIV viral load and host response biomarkers in whole saliva using a microchip device. The device consists of a label-free, multiplexed immunoassay on a disposable microfluidic microchip coupled with a nanoplasmonic reader. Phase I R&D produced core innovations for the proposed product: candidate saliva biomarkers with >96% diagnostic accuracy for acute and unsuppressed HIV infection, and a prototype microfluidic device. These Phase I deliverables provide a solid foundation for the proposed Phase II activities. Key technical objective is to clinically validate the microchip device based on a high diagnostic accuracy for acute and unsuppressed HIV infection in a cross-section of HIV/AIDS patients and controls. SA1 will obtain N=195 saliva samples from 7 cohorts of HIV/AIDS patients and controls. SA2 will validate the diagnostic accuracy of the candidate biomarkers using the clinical saliva samples from SA1. The biomarkers will be measured using a high throughput saliva IHC immunoassay, and confirmed using orthogonal assays: Western blot and SRM mass spectroscopy. SA3 will adapt the prototype microchip device to measure HIV viral load and the candidate biomarkers in whole saliva. The new platform will be validated analytically based on high sensitivity, accuracy and reliability. Clinical validation will be demonstrated based on ?99% diagnostic accuracy for unsuppressed and acute HIV in clinical saliva samples from SA1. This milestone will provide key GO criteria for the commercial product development in Phase III. The proposed product has potential to radically improve the test and treat HIV strategy, help to reduce new infections, increase access to care and improve health outcomes for people living with HIV.