Todos Medical Ltd (OTCQB:TOMDF) has entered into a distribution agreement with Fosun Pharma for the cPass SARS-CoV-2 Neutralizing Antibody Detection Kit.
The kit has received Emergency Use Authorization (EUA) from the US Food and Drug Administration for the detection of SARS-CoV-2 receptor-binding domain (RBD or neutralizing) antibodies.
“With the Delta variant posing a significant risk for breakthrough infections based on data from Israel, and fears increasing of a potential third wave nationwide, we see neutralizing antibody testing becoming critical for informed decision-making to assess who may be best suited for booster shots, as well as at what point someone previously infected with COVID begins to show waning immunity and may decide to receive vaccination as a result,” said Jorge Leon, chief medical officer for Immunology and Oncology at Todos, in a statement.
“As we begin to learn more about the heterogeneity of immune response to different COVID vaccines, there appear to be subgroups of people, who may need an additional dose of the vaccine to be considered fully vaccinated from a neutralizing antibody perspective, and we have now seen the Ministry of Health in Israel just this past week begin to give booster shots to the immunocompromised and certain other at-risk groups, who were shown to have low neutralizing antibody titers.”
Leon added: “Additionally, a recent German study reported that 2% of the general population and over 30% of those over 80 had no detectable neutralizing antibody levels after their second vaccine dose. The cPass test will enable individuals to take charge of their health by making data-driven decisions to protect themselves beyond vaccination, such as masking or avoiding certain higher-risk activities when armed with this crucial information.”
Todos said it sees a large market opportunity developing for cPass that will begin to encroach on the COVID-19 PCR testing market, which rapidly developed into an $80 billion market worldwide in 2020, as immune monitoring will be the primary driver of COVID-19 testing growth going forward.
“As time advances, and more and more individuals are six months and beyond from their initial vaccine dose, it will become increasingly important for individuals and healthcare providers to assess and monitor neutralizing antibody levels in order to make data-driven decisions with respect to booster shots and behavioral changes,” the company said.
Todos said it 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 viruses 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 said it 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.
The company 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 said it sees this modified test as eligible for a higher reimbursement rate than traditional SARS-CoV-2 antibody tests and intends to aggressively market Provista’s new testing capabilities in the coming months to begin to capitalize on its investment in automation and drive high margin revenue growth.
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