Todos Medical Ltd. announced that it has entered into a distribution agreement with Fosun Pharma for the cPass™ SARS-CoV-2 Neutralizing Antibody Detection Kit that has received Emergency Use Authorization (EUA) from the US FDA for the detection of SARS-CoV-2 receptor binding domain (RBD or neutralizing) antibodies. A recent peer-reviewed paper published in the scientific journal Nature Medicine concluded: “… Here, we show that neutralization level is highly predictive of immune protection, and provide an evidence-based model of SARS-CoV-2 immune protection that will assist in developing vaccine strategies to control the future trajectory of the pandemic. Todos sees a large market opportunity developing for cPass that will begin to encroach on the COVID-19 PCR testing market that rapidly developed into an $80 billion market worldwide in 2020. We believe immune monitoring will be the primary driver of COVID-19 testing growth going forward. To date, 161 million people in the United States have been vaccinated, with the majority of the doses having been administered to older populations who are most likely to show waning immunity the earliest, and will be the first ones for whom booster decisions will have to be made. As time advances, and more and more individuals are 6 months and beyond from their initial vaccine dose, it will become increasingly important for individuals and healthcare providers to asses and monitor neutralizing antibody levels in order to make data-driven decisions with respect to booster shots and behavioral changes. The company is currently automating the EUA cPass test at its CLIA/CAP laboratory, Provista Diagnostics (“Provista”), to add high-capacity neutralizing antibody testing to its test menu, and is ramping up its sales and marketing infrastructure. Provista plans to offer cPass as a testing service to other CLIA labs on a reference basis, as well as directly to the public through healthcare professionals. A key differentiator for this novel cPass test is that it detects neutralizing antibodies in patient samples without the use of live virus and with very fast turnaround times, as compared to the conventional method of measuring neutralizing antibodies in patient samples, which requires the use of live cells. Upon completing the automation process, Todos expects Provista to provide high volume results in less than 24 hours. Todos will also make cPass available for client labs to run on their automated equipment. Todos has also been granted authorization to utilize a high value version of the cPass test at Provista that has been adapted to quantitate neutralizing antibody levels, thereby allowing monitoring of levels over time. Todos sees this modified test as eligible for a higher reimbursement rate than traditional SARS-CoV-2 antibody tests. The company intends to aggressively market Provista’s new testing capabilities in the coming months in order to begin to capitalize on its investment in automation and drive high margin revenue growth.