A saliva-based COVID test

REHOVOT, Israel & NEW YORK—Recently, Todos Medical Ltd., an in-vitro diagnostics company focused on the screening and diagnosis of COVID-19 and the development of blood tests for the early detection of cancer and Alzheimer’s disease, announced that it has entered into an exclusive worldwide distribution agreement with Israel-based NLC Pharma to commercially develop its patented virus-focused 3C Protease diagnostic platform for the diagnosis of COVID-19.

“3C Protease quantitation presents a unique approach to viral replication monitoring, and could prove to be a significant tool in the fight against COVID-19,” said Dr. Jorge Leon, senior medical advisor to Todos.

The 3C Protease is a novel target for COVID-19 drug development. It has properties that make it a strong saliva-based biomarker candidate for viral load measurement because it binds to full length viral RNA and is required prior to coronaviruses exiting host cells before going to infect other cells, and it secretes into the saliva for measurement of viral load. Because only full-length RNA is detected, it overcomes potential limitations of technologies that detect viral fractions, such as antigen testing and certain polymerase chain reaction (PCR)-based tests that often yield false positives post-infection.

Todos intends to develop an at-home (or onsite) COVID-19 diagnostic 3C Protease-based test kit for use as a diagnostic for COVID-19, using existing cell phone camera technology and proprietary software to complete the data analysis. The companies will work together toward filing an Emergency Use Authorization (EUA) application with the FDA in the United States and the Ministry of Health in Israel. NLC previously developed working prototypes from its 3C Protease platform for rapid detection of HRV (common cold), HMV (viral meningitis), and SARS.

“As we build Todos into a niche provider of COVID-19 testing solutions to laboratories, healthcare providers and policy makers worldwide, we have identified areas in the diagnostic testing space that require significant innovation, including the development of an ‘Active Infection’ test that is convenient to use and can be deployed at the point of screening prior to gaining access to transmission-risky settings,” said Gerald E. Commissiong, president and CEO of Todos. “We believe this technology gives us a proprietary foothold in a space that is screaming for novel solutions to overcome the biological limitations of current approaches. As we begin the commercialization of our COVID-19 molecular and antibody portfolios, this proprietary technology will give us a marketing advantage as customers look to align with long-term partners. The imbedded cell phone analysis technology will allow for privacy-compliant integration with various contact tracing, telehealth, and employer-based health solutions coming to market.”