10-Minute POC COVID-19 Test Accurately Detects SARS-CoV-2 3C-Protease in Saliva Samples

A new 10-minute rapid point-of-care saliva-based test for detecting active SARS-CoV-2 infections has provided positive proof-of-concept data by achieving analytical performance for detecting active 3C-protease in a rapid visual format.

The proof-of-concept analytical performance data demonstrate that the assay is able to 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. The 3C-Protease is a coronavirus-derived protein that is required for viral replication and transmission to other cells and tissues. The 3C-Protease assay detects the presence of active viral replication specific to SARS-CoV-2, rather than host reactions to current or previous other coronavirus infections, or the detection of viral genetic fragments that continue to shed from patients who have recovered from COVID-19. As more people become infected and recover from COVID-19 worldwide, it is becoming increasingly important for a molecular assay to distinguish active, replicating SARS-CoV-2 virus from inactive, non-replicating SARS-CoV-2 genetic fragments.

Based on these data, Todos Medical Ltd. (Rehovot, Israel) which has developed the test has initiated a multicenter clinical trial to evaluate the clinical performance of the assay and optimize product development prototypes for commercial scale-up. The technology holds promise to provide a rapid result without the need for heating, expensive instrumentation, inconvenient sample collection or cold-chain logistics. Todos aims to develop both quantitative and qualitative tests based on the technology and intellectual property. The company is working to complete this initial clinical trial in the third quarter of 2020, with trial results and submissions to regulatory agencies worldwide in the fourth quarter of 2020.

“These data provide proof-of-concept for the 3C-Protease diagnostic approach in COVID-19 testing,” said Dr. Jorge Leon, consulting Chief Medical & 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.”

“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 Pharma, Todos’ joint venture partner. “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.”

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Todos Medical Ltd.