Accure Health has announced positive data for its TiMES-Now assay from a proof-of-concept study assessing immune response to Covid-19 vaccines.

The technology-integrated magneto-electronic sensing (TiMES) is a digital diagnostic platform that integrates reagents, circuits, and algorithms into one compact system.

The study, entitled ‘A Rapid Saliva Test for Monitoring Immune Protection against SARS -CoV-2 and its Variants’ was published on open-access preprint repository MedRxiv.

According to the study data, the novel saliva assay can monitor neutralising antibody levels, and model immune protection against SARS-Cov-2 variants.

Accure Health co-founder and CEO co-founder Jessica Sang said: “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 neutralising antibody levels over time, and generate valuable datasets to model immune protection against major variants.

“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 Health validated its TiMES digital platform and TiMES-Now assay in a pilot study, monitoring the immune response levels against SARS-CoV-2 in 111 saliva samples.

TiMES-Now assay outperformed standard laboratory blood tests in many ways, and showed 100 times more sensitivity compared to ELISA, said the company.

The technology used in Accure’s tests was initially developed at the Harvard Medical School and Massachusetts General Hospital.

It converts molecular data from biological fluid directly into electrical signals, to eliminate the limitations of existing diagnostic devices, and improves the speed and sensitivity of the tests.

Accure has secured an exclusive global license to commercialise the technology, which was proven to detect cancer and other diseases from blood or urine specimens.

Harvard Medical School associate professor of medicine Cesar M Castro said: “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.

“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.”