Todos Medical Ltd (OTCQB:TOMDF) Wednesday announced what it called “positive clinical proof of concept data” from its lab-based rapid SARS-CoV-2 3CL protease diagnostic test in collaboration with its joint venture partner NLC Pharma.
The company said the data, which was generated by NLC Pharma in Israel, produced 100% sensitivity and 100% specificity in PCR-confirmed positive and negative COVID-19 patient samples.
Todos Medical Chief Medical & Scientific Officer Jorge Leon said in a statement: “We believe that our rapid testing 3CL technology will successfully pair with the antigen testing distribution networks being established to bring the point-of-care version of our 3CL assay into the market for widespread uptake as the long-term solution for rapid point of care COVID testing. In the meantime, we will deploy our clinical lab-based 3CL assay together with our existing PCR testing distribution networks to confirm that positive PCR tests are, in fact, picking up actively replicating virus versus inactive viral remnants that can sometimes show false positive RT-PCR results, keeping the person in quarantine needlessly. This would be quite an important addition to the current emerging COVID-19 testing paradigm.”
Todos Medical noted that its team is now gathering additional clinical data to submit an emergency use authorization (EUA) to the United States Food & Drug Administration (FDA) for its lab-based test to be distributed through the company’s existing lab distribution channels. Todos added that it is evaluating the best option for the commercialization of its rapid point-of-care version of the 3CL protease assay for the screening and diagnosis of symptomatic and asymptomatic COVID-19 carriers, based on recent updated guidance from the FDA for COVID-19 diagnostic point of care tests.
Todos Medical CEO Gerald Commissiong said in a recent update to shareholders that it is “squarely focused” on COVID-19 for the immediate term and expects revenues generated from sales of its COVID-19 testing solutions to be a near-term driver of business, this while continuing “to capitalize on the very significant programs we have in cancer and Alzheimer’s diagnostics."
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