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Todos Medical has completed validation of its cPass neutralizing antibody blood test to monitor COVID-19 immunity.
Todos Medical, a medical diagnostics company, announced that its lab, Provista Diagnostics, has successfully completed the validation studies required to put its cPass neutralizing antibody blood test into production. The company expects to launch the new test in September 2021, and Provista Diagnostics can do up to 20,000 polymerase chain reaction tests and over 1500 cPass tests per day, according to a company press release.
The blood test received Emergency Use Authorization from FDA for the detection of neutralizing antibodies (NAbs) that could be used to monitor key biomarkers of COVID-19. Individuals who acquired their immunity through either vaccination or natural infection will be able to monitor their immunity levels with the device.
This product comes on the heels of breakthrough infections in vaccinated individuals and discussions surrounding whether booster shots are necessary. FDA recently sent out a recommendation advising immunocompromised individuals to consider a third shot.
“We saw our local community in the greater Atlanta area ravaged by the first and second waves of the disease due to a lack of testing capability, and felt we had an obligation to be more proactive to fulfill the market need just as schools and business prepare to open for the fall.” said Gerald Commissiong, president & CEO of Todos Medical, in the press release. “We think cPass could play a pivotal role in helping roll out booster shots to those at-risk in the months ahead.
Source: Todos Medical