Todos Medical, an Israeli in-vitro diagnostics company, has announced positive proof-of-concept data for a 10-minute, rapid point-of-care saliva-based test for detecting active SARS-CoV-2 infections. Todos has built its business on engineering diagnostics for early detection of a variety of cancers using a technology that seeks biochemical changes in blood mononuclear cells and plasma. The arrival of COVID-19, however, prompted a shift in priorities, leading them to focus on the development of a rapid saliva test for screening for COVID-19 infection.

 

According a company news release, the data demonstrate that their assay can accurately detect the SARS-CoV-2 3C-protease in human saliva samples spiked with recombinant 3C protease, and that the protease signal was specifically and significantly distinguishable from background protease activity present in normal saliva. Based on these data, they have initiated a multicenter clinical trial at Assuta Ashdod Hospital and Tel Aviv University in Israel to evaluate the clinical performance of the assay, and optimize product development prototypes for commercial scale-up.

 

“These data provide proof-of-concept for the 3C-protease diagnostic approach in COVID-19 testing,” said Dr. Jorge Leon, consulting chief medical and scientific officer of oncology and infectious disease for Todos. “The clinical trial in Israel will generate real-world data on how best to integrate this technology platform into products that can be deployed worldwide. We will now begin incorporating the software to analyze this assay into an application for use with mobile phones and various telemedicine platforms, so as to provide a more complete and efficient solution for COVID-19 testing and data reporting for all stakeholders.”

 

The 3C-protease is a coronavirus-derived protein that is required for viral replication and transmission to other cells and tissues. A recently published study in Science Translational Medicine indicated that the X-ray crystal structure of a key protein in the virus’ life cycle is its main protease in instances of COVID-19. That research indicated that “the enzyme cuts the polyproteins translated from viral RNA to yield functional viral proteins.”

 

Building on that knowledge, Todos announced that their 3C-protease assay can detect active SARS-CoV-2 infection, as opposed to a reaction to previous coronavirus infections, or as a response to the lingering biology following a COVID-19 infection. They have already seen millions of people infected with the disease, therefore it is critical to find an assay that detects actively replicating SARS-CoV-2 virus and not remnants of other infections or other diseases.

 

“We are extremely pleased to have confirmed the usefulness of our 3C-protease patented viral detection technology for COVID-19,” said Dr. Dorit Arad, chief scientific officer of NLC Phara, a partner with Todos on the research. “With these data in hand, we see a clear path to apply our technology at large scale to provide widespread rapid, highly sensitive molecular testing to make a difference in the rapid detection of active COVID-19. We believe this sets the stage for significant growth within our joint venture with Todos.”

 

What makes the technology particularly promising is its point-of-care nature and its ease of use. As a saliva-based screening tool, the challenges of sample care, transport and contamination are avoided. This will potentially make the test easy to use in clinical settings, places characterized by high traffic volume—and even at home.

 

In conjunction with NLC Pharma, Todos has used the first half of 2020 to explore these diagnostic tests that perform distinctly from currently available tests, while also exploring identifiers of how the virus replicates, an indicator of viral load. Todos is working to complete its initial clinical trial in the third quarter of 2020, with trial results and submissions to regulatory agencies worldwide in the fourth quarter of 2020.