CAMBRIDGE, Mass.– Accure Health, a developer of rapid digital diagnostics, today announced the online publication of preliminary data showing that its novel saliva assay can assess individual immune response to COVID-19 vaccines, monitor neutralizing antibody levels over time, and model immune protection against SARS-Cov-2 variants.
The publication, titled A Rapid Saliva Test for Monitoring Immune Protection against SARS -CoV-2 and its Variants was made available on open-access preprint repository MedRxiv on July 14, 2021.
In a pilot study involving 111 participants, Accure Health demonstrated the potential of its TiMES digital platform and TiMES-Now assay in monitoring the neutralizing antibody levels against SARS-CoV-2 in saliva samples. TiMES-Now outperformed conventional blood tests in several key areas. Compared to enzyme-linked immunosorbent assay (ELISA), TiMES-Now was 100 times more sensitive, while also being considerably faster (30 mins vs. several days) and less expensive than standard laboratory blood tests.
“Critical questions such as the durability of COVID-19 immunity or the clinical efficacy of vaccines require large datasets to generate meaningful insights. However, many immunity assays are complex and require blood-drawing specialists and are therefore mostly limited to small-scale clinical studies,” said Dr. Cesar M. Castro, Associate Professor of Medicine at Harvard Medical School and Director of the Cancer Program within the Center for Systems Biology at the Massachusetts General Hospital. “At the other end of the spectrum are at-home finger-stick tests which only offer a qualitative “yes/no” reading and thus have limited utility. Accure Health’s novel saliva test has strong potential to fill the gap with a portable device that provides easy access to timely information making ongoing immune surveillance more feasible which is especially important for vulnerable populations.”
“With Accure Health’s newly-developed TiMES-Now saliva assay, we were able to rapidly assess SARS-CoV-2 immunity following infection or vaccination, monitor neutralizing antibody levels over time, and generate valuable datasets to model immune protection against major variants,” said Jessica Sang, Ph.D., co-founder, and CEO of Accure Health. “The test also allowed a closer examination on how different subpopulations, particularly immunocompromised patients, responded to the vaccines. And it’s not just neutralizing antibodies – additional immune biomarkers can be examined too. TiMES-Now provides an affordable, data-driven and highly-accurate solution for the rapid assessment of personalized immune response as well as population immunity, that can help inform vaccination strategy.”
Accure’s TiMES (Technology-integrated Magneto-Electronic Sensing) is a fully integrated digital diagnostic platform incorporating proprietary reagents, circuits, and algorithms into one compact, easy-to-use system. By converting molecular data from biological fluid directly into electrical signals, Accure bypasses the limitations of existing optical diagnostic devices and significantly improves the speed and sensitivity of its tests.
The technology was initially developed at the Harvard Medical School and Massachusetts General Hospital. It has been previously demonstrated to accurately detect cancer and other diseases from blood or urine specimens. A new study on colorectal cancer detection was concurrently published in Nature Biomedical Engineering. Accure has obtained a worldwide exclusive license to commercialize the technology. The TiMES-Now saliva test is currently only available through clinical studies approved by an Institutional Review Board.
