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Todos Medical CLIA/CAP Lab Provista Submits Emergency Use Authorization Application for MonkeyPox PCR Test to US FDA
Todos Medical CLIA/CAP Lab Provista Submits Emergency Use Authorization Application for MonkeyPox PCR Test to US FDA.
About this update from Todos Medical Ltd.
[{"type":"text","content":"\n 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.” About Todos Medical Ltd.Founded in Rehovot, Israel with offices in New York City, Todos Medical Ltd. (OTCQB: TOMDF) engineers life-saving diagnostic solutions for the early detection of a variety of cancers. The Company's state-of-the-art and patented Todos Biochemical Infrared Analyses (TBIA) is a proprietary cancer-screening technology using peripheral blood analysis that examines cancer's influence on the immune system, looking for biochemical changes in blood mononuclear cells and plasma. Todos’ two internally developed cancer-screening tests, TMB-1 and TMB-2 have received a CE mark in Europe. Todos recently acquired U.S.-based medical diagnostics company Provista Diagnostics, Inc. to gain rights to its Alpharetta, Georgia-based CLIA/CAP certified lab currently performing PCR COVID testing, Long COVID Panel analyses, and Provista's proprietary commercial-stage Videssa® breast cancer blood test. More information on Provista is available at www.provistadx.com. Todos is also developing blood tests for the early detection of neurodegenerative disorders, such as Alzheimer's disease. The Lymphocyte Proliferation Test (LymPro Test™) is a diagnostic blood test that determines the abilit...