Todos Medical said that the current lesion-based laboratory-developed test (LDT) has a sensitivity of 0.95 viral copies per reaction (0.095 copies/ul)
Provista Diagnostics, part of diagnostics company Todos Medical, has submitted an Emergency Use Authorisation (EUA) application with the US Food & Drug Administration (FDA) for its PCR MonkeyPox Test.
US-based CLIA/CAP-certified clinical laboratory Provista Diagnostics has filed the EUA application with the FDA for lesion-based PCR (polymerase chain reaction).
According to Todos Medical, the current lesion-based laboratory-developed test (LDT) has a sensitivity of 0.95 viral copies per reaction (0.095 copies/ul).
Todos Medical and Provista president and CEO Gerald Commissiong said: “The submission of this EUA application underscores our commitment to providing best-in-class PCR-based testing for emerging infectious diseases.
“Regulatory changes at FDA have forced us to only be able to offer lesion-based PCR testing. As we conduct more research and work with the agency, we are hopeful to be able to submit an EUA for saliva-based PCR testing for MonkeyPox in the future.”
Todos recently acquired Provista Diagnostics to gain access to the lab’s CLIA/CAP-certified facility in Alpharetta, Georgia, where Provista currently conducts PCR COVID testing, Long COVID Panel analyses, and the commercial-stage Videssa breast cancer blood test.
Additionally, Todos is creating blood tests for the early recognition of neurodegenerative disorders like Alzheimer’s disease.
In August this year, Todos Medical, through its recently acquired medical diagnostics company Provista Diagnostics, is commercialising its PCR-based MonkeyPox testing in the US.