Wednesday, September 28, 2022
Todos Medical, Ltd., a comprehensive medical diagnostics and related solutions company, today announced that its majority-owned joint venture 3CL Pharma Ltd. received a Notice of Allowance issued by the USPTO for the Company’s proprietary SARS-CoV-2 3CL protease (Main protease, Mpro, Nsp5) diagnostic TolloTest™ that was developed to detect and quantify the presence of 3CL protease in human tissue samples. TolloTest has been initially validated in upper respiratory tract (swab) samples and can provide PCR-like accuracy with convenience similar to that of a rapid antigen test. The Company previously announced positive data on TolloTest in hospitalized and outpatient settings such as skilled nursing facilities and schools.
The test is designed to quantify 3CL protease, which is being measured for correlation with infectiousness and potentially a key feature of the SARS-CoV-2 viral persistence pathology in Long COVID. TolloTest is a potential companion biomarker test for the Company’s 3CL protease inhibitor dietary supplement Tollovid and a companion diagnostic for its Phase 2 asset Tollovir for hospitalized COVID. TolloTest can be commercialized as a rapid point-of-care test in single use and mass screening formats, as an at-home test for single use, and as a laboratory developed test (LDT) for use in high complexity CLIA labs and mobile labs for patient monitoring.
“The tremendous work we did in Israel in discovering and proving this 3CL protease disease mechanism will be crucial in the next steps of expanding the widespread adoption of supplements and drugs to reduce SARS-CoV-2 replication and immune system downregulation,” said Dr. Dorit Arad, Founder and Chief Technology Officer at 3CL Pharma.
“The US market is huge and is in desperate need for new types of diagnostics to measure different aspects of the SARS-CoV-2 virus, especially in hospitalized patients and Long COVID,” said Gerald Commissiong, CEO of 3CL Pharma. “Many of our existing testing customers in schools and nursing homes utilize our PCR testing to try to control community spread. The TolloTest has the potential to be a much better mousetrap in controlling community spread because it could detect people earlier in the disease pathogenesis. As such, we believe the 3CL protease is something that should be monitored closely, especially since there are products on the market in the US that address it, and it could result in a change in physician recommendations.”
The global COVID-19 diagnostics market size is expected to reach USD 50.1 billion by 2030, according to a new report by Grand View Research, Inc. The market is expected to expand at a CAGR of 7.7% from 2022 to 2030. The Company expects significant innovation will be required to improve the accuracy of point of care diagnostics and TolloTest could play a key role in area.
