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Posted On: 10/14/2022 9:45:28 AM
Post# of 1418
Todos Medical CLIA/CAP Lab Provista Submits Emergency Use Authorization Application for MonkeyPox PCR Test to US FDA
New York, NY, and Tel Aviv, ISRAEL, Oct. 14, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire --Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced that its CLIA/CAP-certified clinical laboratory Provista Diagnostics has filed an Emergency Use Authorization (EUA) application with the US Food & Drug Administration (FDA) for its PCR MonkeyPox Test. The EUA application was submitted for lesion-based PCR. The sensitivity achieved for the currently available lesion-based laboratory-developed test (LDT) is 0.95 viral copies per reaction (0.095 copies/ul).
“The submission of this EUA application underscores our commitment to providing best-in-class PCR-based testing for emerging infectious diseases,” said Gerald E. Commissiong, President & CEO of Todos Medical and Provista. “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.”
https://investor.todosmedical.com/news-events...rgency-use
New York, NY, and Tel Aviv, ISRAEL, Oct. 14, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire --Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced that its CLIA/CAP-certified clinical laboratory Provista Diagnostics has filed an Emergency Use Authorization (EUA) application with the US Food & Drug Administration (FDA) for its PCR MonkeyPox Test. The EUA application was submitted for lesion-based PCR. The sensitivity achieved for the currently available lesion-based laboratory-developed test (LDT) is 0.95 viral copies per reaction (0.095 copies/ul).
“The submission of this EUA application underscores our commitment to providing best-in-class PCR-based testing for emerging infectious diseases,” said Gerald E. Commissiong, President & CEO of Todos Medical and Provista. “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.”
https://investor.todosmedical.com/news-events...rgency-use
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