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Cell Microsystems and UNC’s HIV Cure Center will continue their work on developing an automated assay that can measure single cells for latent HIV, thanks to a two-year, $1.65 million contract from the National Institutes of Health. The new contract, a highly competitive phase II Small Business Innovation Research award, affirms the partners’ success resulting from a phase I SBIR award in September 2018.

The research helps address a key challenge in the decades-long quest for a cure to HIV: fighting the virus’ ability to hide in the body in a dormant state. This latent viral reservoir persists in people living with HIV despite years of antiretroviral therapy, and it allows the virus to rebound if therapy is ever interrupted.

Ed Browne Jessica Hartman head shots “We want to identify and eliminate the remaining virus in people living with HIV on therapy, but we haven’t been able to easily measure or quantify the viral reservoir,” says Edward Browne, PhD, assistant professor of infectious diseases who is leading the research for the Cure Center. “As we develop new tools to attack and clear the viral reservoir, we need a reliable way to measure the amount of infectious virus that remains in each person.”

Remaining infected cells are rare and hard to detect, so the measuring tool has to be highly sensitive. “The main existing assay for measuring latent HIV in people, QVOA, is time consuming and technically difficult, so it can’t be practically scaled up for use in large clinical trials,” Browne says. Instead, he has been working with Cell Microsystems scientists and engineers to build an assay that miniaturizes the QVOA assay into an array of nanoliter-sized wells and uses a fluorescent reporter cell line to detect the virus. “We’re hoping that this assay will be faster and easier to perform than QVOA without losing accuracy.”

Phase II funding allows researchers to explore a project’s commercial and scientific viability. “Phase I showed that this assay can work in principle to accurately detect and quantify very small numbers of rare HIV-infected cells,” Browne says. “Our plan with phase II is to validate this approach using samples from people living with HIV and compare our assay to QVOA. We used off-the-shelf technology for phase I. For phase II, we plan to work with the team at Cell Microsystems on a custom design.”

“Phase II funding provides an opportunity to design and build an automated platform uniquely suited to performing the new assay,” says Gary Pace, PhD, JD, CEO of Cell Microsystems. The company, which commercializes instruments and consumables for single-cell workflows, has worked on a number of collaborations with UNC researchers on NIH-funded programs. “Led by Jessica Hartman, PhD, as Cell Microsystem’s principal investigator for the project, we’re aiming for a commercial product that can be used in drug screening, as a diagnostic tool for clinical trials, and someday become useful in a patient setting.”

About UNC’s Institute for Global Health & Infectious Diseases
The Institute for Global Health & Infectious Diseases works to harness the full resources of the University and its partners to solve global health problems, reduce the burden of disease, and cultivate the next generation of global health leaders.

About UNC HIV Cure Center
The HIV Cure Center focuses on finding a cure for HIV/AIDS by working closely with academic and industry partners. HIV eradication is a complex health challenge due to the long-lived persistence of the virus in the body, which hides in latently infected cells that are able to escape the body’s immune system. The HIV Cure Center research portfolio is focused on reactivation of the latent virus combined with clearance strategies to effectively purge the HIV reservoir to effect a cure for HIV.

About Cell Microsystems
Cell Microsystems is an early growth stage company that brings innovation to single cell biology, cell culture, and cloning workflows. By gently sorting on our CytoSort™ Arrays, single cells are more viable and have less perturbed phenotypes compared to traditional methods. Coupled with our automated CellRaft® AIR System, a user can select a cell in real time and ‘track and trace’ that cell through imaging, collection and downstream analysis. The platform enables a complete workflow from single cells, such as generating CRISPR gene edited clones, cell line development, antibody discovery, T-cell screening, and image-based phenotyping.

This project has been funded in whole or in part with federal funds from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, Department of Health and Human Services, under Contract No. 75N93020C00050 awarded to Cell Microsystems with the UNC HIV Cure Center as the subcontractor.