Todos Medical Ltd. has announced that its CLIA/CAP certified lab Provista Diagnostics has successfully completed the validation studies required to put the Quidel (NASDAQ:QDEL) Lyra Influenza A & B and the Lyra RSV & hMPV PCR kits into production.
The company said kits will be produced alongside COVID PCR tests currently being run (Provista Respiratory Panel) and expects this new respiratory panel to be launched in September 2021.
The validation coincides with the recent validations for the cPass semi-quantitative COVID neutralizing antibody test and the Kogene COVID variant detection kits also being launched in September 2021.
READ: Todos Medical says its Provista Diagnostics lab completes validation of Kogene Variant Test Kit to identify coronavirus variants
Todos said this positions Provista to now offer a turnkey solution for healthcare, businesses, school systems, government agencies, and others seeking access to a high-quality comprehensive lab to support testing programs as the US economy continues its reopening heading into the fall of 2021.
“As the nation heads back to school, and many children head back into classrooms for the first time in nearly 18 months, there is significant risk for a resurgence in influenza and RSV viruses that declined dramatically during the pandemic,” said Todos CEO Gerald Commissiong in a statement.
“We’ve already seen evidence of a resurgence in RSV over the summer in certain southern states in the US, and now heading into Fall 2021 flu season it is critical that pediatricians are able to make accurate diagnoses so that kids can be quarantined if needed due to COVID, or they can be quickly returned to the classroom when initial symptoms resolve in the event of another respiratory illness as often happens during the school year. Children’s immune systems have largely not been exposed to many respiratory pathogens over the last 18 months, and so it is important that communities are prepared to deal with multiple respiratory illnesses that present with similar symptoms.”
Commissiong said the major challenge pediatricians will be facing this fall with point-of-care antigen tests often used for respiratory pathogens is that, similar to COVID, many respiratory illness antigen tests produce false-negative results early on in the disease process. As a result, many diagnoses are only caught at a second doctor’s visit.
He added: “The CDC recently updated its guidance to encourage COVID and flu testing simultaneously, and we’ve taken that one step further by adding RSV and hMPV to our PCR respiratory panel because of the dramatic and unexpected rise of these respiratory pathogens over the summer of 2021. By working with Provista, physicians will be able to use the same specimen sample collected for COVID to get highly accurate lab results using PCR for COVID, influenza A & B, RSV and hMPV, so they can have confidence on a treatment plan and the timing of when kids can be returned to the classroom.”
Todos said it sees a large market opportunity developing for respiratory illness testing that is an adjunct to the COVID-19 PCR testing market that rapidly developed into an $80 billion market worldwide in 2020.
Provista has the automation in place to do up to 20,000 COVID PCR tests, over 1,500 cPass tests per day, over 5,000 COVID variant tests per day, and over 5,000 respiratory panel tests per day when at full capacity. The CMS reimbursement rate for the Provista Respiratory Panel is $142.
In other company news, CEO Commissiong will appear on the Yahoo! Finance Live Show at 4:10 pm EDT today (September 1) to discuss the recent developments at Provista as well as its plans to advance Tollovir, the company’s oral, dual mechanism 3CL protease inhibitor/anti-cytokine antiviral drug candidate for COVID-19 treatment currently in a Phase 2 clinical trial for hospitalized patients in Israel.
The company is preparing to expand its trials to include pivotal Phase 2/3 trials in both hospitalized and non-hospitalized COVID patients that it expects to initiate in the coming weeks.
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