Todos Medical CLIA/CAP Lab Provista Submits Emergency Use Authorization Application for MonkeyPox PCR Test to US FDA
Todos Medical, Ltd. (OTCQB: TOMDF) has submitted an Emergency Use Authorization (EUA) application for its PCR MonkeyPox Test to the FDA. The test shows a sensitivity of 0.95 viral copies per reaction. CEO Gerald Commissiong emphasized the commitment to advanced PCR testing for emerging infectious diseases amid regulatory changes limiting testing methods. The company, also known for its cancer diagnostics, recently acquired Provista Diagnostics, enhancing its laboratory capabilities for COVID and MonkeyPox testing.
- Submission of EUA for PCR MonkeyPox Test shows proactive regulatory engagement.
- Achieved high sensitivity (0.95 copies/reaction) for the MonkeyPox test, indicating effective testing capability.
- Recent acquisition of Provista Diagnostics enhances laboratory testing capabilities.
- Regulatory changes restrict testing to lesion-based PCR, limiting testing options.
- Future EUA for saliva-based PCR testing is uncertain, depending on further research and FDA cooperation.
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 ability of peripheral blood lymphocytes (PBLs) and monocytes to withstand an exogenous mitogenic stimulation that induces them to enter the cell cycle. It is believed that certain diseases, most notably Alzheimer's disease, are the result of compromised cellular machinery that leads to aberrant cell cycle re-entry by neurons, which then leads to apoptosis. LymPro is unique in the use of peripheral blood lymphocytes as a surrogate for neuronal cell function, suggesting a common relationship between PBLs and neurons in the brain.
Todos formed the Israeli-based majority-owned joint venture 3CL Pharma, Ltd with NLC Pharma in March of 2022 to consolidate all of the intellectual property surrounding 3CL protease–based diagnostic testing and development of 3CL protease botanical and pharmaceutical inhibitors that target a fundamental reproductive mechanism of coronaviruses. 3CL Pharma, through Todos’ brand, has commercialized the 3CL protease inhibitor immune support dietary supplement Tollovid™ in the United States, is developing the dual mechanism 3CL protease inhibitor and anti-cytokine therapeutic drug candidate Tollovir™, while also developing the 3CL protease diagnostic TolloTest™.
To purchase Tollovid please visit Amazon or www.MyTollovid.com. For more information, please visit https://www.todosmedical.com/.
Forward-looking Statements
Certain statements contained in this press release may constitute forward-looking statements. For example, forward-looking statements are used when discussing our expected clinical development programs and clinical trials. These forward-looking statements are based only on current expectations of management, and are subject to significant risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection for product candidates; competition from other biotechnology companies; and our ability to obtain additional funding required to conduct our research, development and commercialization activities. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; delays or obstacles in launching our clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our process; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from the competition; and laboratory results that do not translate to equally good results in real settings, all of which could cause the actual results or performance to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Todos Medical does not undertake any obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Todos Medical, please refer to its reports filed from time to time with the U.S. Securities and Exchange Commission.
Todos Corporate Contact:
Daniel Hirsch CFO
Todos Medical
917-983-4229 x 104
Dan.h@todosmedical.com
Todos Press Contact:
Giancarlo Greager
TreviPR
702-768-1906
giancarlo@trevipr.com
FAQ
What is the current status of the EUA for Todos Medical's MonkeyPox Test?
What sensitivity does the MonkeyPox Test show?
How does the recent acquisition of Provista Diagnostics affect TOMDF?
What challenges does Todos Medical face due to regulatory changes?
