Alpharetta, Ga.-based Provista Diagnostics, a clinical diagnostics lab owned by medical diagnostics company Todos Medical, cleared all necessary hurdles to begin producing its new respiratory test panel, the lab said in a Sept. 1 news release.
The test panel includes kits for influenza A and B and polymerase chain reaction test kits for respiratory syncytial virus, human metapneumovirus and COVID-19. Provista said the panel, which CMS will reimburse at a rate of $142, should launch in September 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," Gerald Commissiong, president and CEO of Todos Medical, said in the release.
"The major challenge pediatricians will be facing this fall ... is that, similar to COVID, many respiratory illness antigen tests produce false negative results early on in the disease process, and therefore many diagnoses are caught at a second doctor's visit," Mr. Commissiong said. "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."