ABSTRACT
The global HIV epidemic has profoundly impacted public health. HIV affects tens of millions of people worldwide,
including over a million in the United States. While antiretroviral therapy (ART) allows individuals to suppress the
virus and live normal lives, it is expensive, has side effects, and requires lifelong adherence. The need for a cure
has led to the development of new therapeutic strategies. However, large-scale clinical testing is hindered by
the low virus concentration in blood during ART and the lack of sensitive, cost-effective point-of-care (POC) tests
for measuring small changes in viral load on a regular basis. There is an urgent need for a test that can
quantitatively differentiate between individuals maintaining suppression after stopping ART and those
experiencing viral rebound, so as to enable quick detection of rebounds and re-initiation of therapy.
The goal of the project proposed here is to develop a POC-compatible quantitative test for accurate viral load
monitoring that could support large-scale clinical trials of HIV cure strategies. Our approach uses digital loop-
mediated isothermal amplification (dLAMP), which has been shown to provide precise viral load measurements
on raw, unpurified samples. Such capabilities make dLAMP well suited for POC settings. Our collaborative
network, composed of engineers, clinical experts, and researchers, will collaborate to create a groundbreaking
diagnostic platform that addresses major limitations in HIV testing and accelerates progress towards an HIV
cure. By leveraging the combined expertise and resources, we will develop a cost-effective microfluidic
consumable test and reusable assay instrument. Ultimately, this tool will improve HIV management and
eradication efforts.
This project will be led by Fluid Discovery, whose mission is to commercialize point-of-care pathogen diagnostics
based on digital LAMP technology. Through the support of Professor Adam Abate, who will also guide
development of the technology, the company will collaborate with UCSF and the Gladstone Institute
investigators. These include Dr. Charles Chiu (Director of the CLIA-certified Pathogen Testing Lab) and Dr.
Melania Ott (Director of Virology at the Gladstone Institute), who will support the validation process. Additionally,
the project will involve collaborations with Dr. Steven Deeks (Director of the Delaney AIDS Research Enterprise
to Find a Cure, which oversees and invests in clinical trials of new therapies) and Dr. Michael Busch (Director at
Vitalant Research Institute). The project will utilize authentic biospecimens from the SCOPE and RAVEN trials.
Working with Fluid Discovery, this team will apply the technology to demonstrate its utility for HIV load monitoring.
