Diomics, a San Diego-based biotech company, announced on Aug. 19 that it is developing the Diocheck Antibody Indicator, which provides a simple way for individuals to monitor for the presence of antibodies to SARS-CoV-2 over an extended period of time.

Diomics’ CEO likened it to a modernized version of the 100-year-old tuberculosis test.

Based on Diomics’ proprietary usage of an FDA-approved material, Diomat bioresorbable polymer, Diocheck detects and reports within 24 to 36 hours whether a person has developed a circulating level of SARS-CoV-2-specific antibodies. A positive response causes a visible change to the Diocheck skin patch, which resembles a nicotine patch and is expected to be effective for up to 14 days.

The Diocheck patch monitors the critical gap between when a person receives a vaccine and when a protective level of antibodies is circulating in the body, which current reports suggest could take several weeks. It can also signal when the antibodies stimulated by a vaccine have declined and the person needs a booster.

Diocheck reduces the uncertainty surrounding vaccines by offering independent, visual assurance of the presence of a protective level of antibodies as well as a way to monitor if antibody protection has waned.

The company is also developing a second, intradermal product that will use nano-sized beads of the same biopolymer inserted just under the skin to detect and visually report the formation of antibodies to SARS-CoV-2, potentially for up to one year, before being safely absorbed by the body.

Diomics said that both forms of Diocheck are readily scalable and “hold the promise of consistent, accurate, ongoing monitoring of the protective antibody status of essential front-line workers, including military, healthcare, transportation and public safety personnel, as well as teachers and students.”

The Diocheck system is expected to move from pre-clinical to human clinical trials in late September. Pre-clinical studies are taking place through a partnership between Diomics and the University of California, Irvine under the guidance of Jonathan R.T. Lakey, Ph.D., M.S.M., Professor of Surgery and Biomedical Engineering. UCI clinical trials will be led by Daniela Bota, M.D., Ph.D., Vice Dean for Clinical Research and her team at the Alpha Stem Cell Clinic.

“Diocheck is a unique approach to pandemic protection,” said Diomics CEO Anthony Zolezzi. “Whether a person wishes to monitor the efficacy of a vaccine or use Diocheck because they have not been vaccinated, we plan to offer the public a variety of monitoring options.

“Diocheck is like a modernized version of the 100-year-old tuberculosis test in which the presence of a SARS-CoV-2 antigen binding to the Diomat material results in an easily seen indication for early detection and monitoring.”