NEW YORK ─ Todos Medical on Monday announced it has entered into a distribution agreement with Fosun Pharma for GenScript Biotech's cPass SARS-CoV-2 Neutralizing Antibody Detection Kit.
Todos said it is automating the cPass test at its Provista Diagnostics CLIA-certified, CAP-accredited laboratory 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 and to healthcare professionals. Todos said it expects Provista to provide high volume results in less than 24 hours. Todos will also make cPass available for customer labs to run on their automated equipment.
Last November, the US Food and Drug Administration granted Emergency Use Authorization for the GenScript kit, saying it was the first SARS-CoV-2 neutralizing antibody test to receive EUA.
Rehovot, Israel-based Todos said it sees a large market opportunity developing for cPass and believes that immune monitoring will be a primary driver of COVID-19 testing growth going forward.
Todos sees "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,” Jorge Leon, chief medical officer for immunology and oncology at the firm, said in a statement.
In April, GenScript announced that it had inked an exclusive distribution agreement with IES Diagnostics to distribute its SARS-CoV-2 antibody kit in Spain, Portugal, and Andorra.
Also in April, Todos announced it had acquired Provista Diagnostics for a total of $7.5 million in cash and stock.