Provista begins validation preparations for blood-based IgM/IgG MonkeyPox LDT
Company to release its Q2/2022 10Q quarterly report at 4:05 pm ET this afternoon
Company to host business update conference call on Tuesday, August 23rd at 8:30 am ET
Tel Aviv - (NewMediaWire) - August 22, 2022 - Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced that its Atlanta-area CLIA/CAP-certified clinical laboratory Provista Diagnostics, Inc. has completed CLIA validation and has commercially-launched PCR-based MonkeyPox testing in the United States.
The sensitivity achieved for the currently available lesion-based laboratory-developed test (LDT) is 1.2 viral copies per reaction (0.12 copies/ul), with identical sensitivity (1.2 viral copies per reaction) achieved for its saliva-based test that has also completed CLIA validation protocols. Provista has also completed implementation of upgraded safety protocols to be in compliance recommended CDC protocols for MonkeyPox which are in line with biosafety 3 level (BSL3) laboratory protocols. Provista will collect saliva samples matched with lesion swabs from confirmed MonkeyPox cases before launching a standalone LDT targeted at identifying MonkeyPox in the pre-symptomatic stage. In situations of known exposure to confirmed or suspected MonkeyPox cases for which there are no symptoms, Provista intends to make saliva-based MonkeyPox PCR testing available that may make them eligible for the FDA approved MonkeyPox vaccine Jynneos or Tecovirimat (TPoxx) antiviral therapy under an early access investigational new drug application (EA-IND) through the CDC, in partnership with the US Food & Drug Administration (FDA). Other uses of PCR MonkeyPox testing include wastewater surveillance, as well as wild animal surveillance to understand whether animal populations begin to carry viral reservoir that could ultimately spillover back into new human populations. The Company is also preparing validation plans for an IgM/IgG blood-based MonkeyPox LDT to confirm recent infection as part of a planned MonkeyPox Panel.
“We are positioning Provista to become a leader in MonkeyPox testing given that MonkeyPox has been recently labeled a public health emergency by the US Government, and as such there is an urgent need to ramp up testing availability in order to facilitate the containment of outbreaks,” said Gerald E. Commissiong, President & CEO of Todos Medical. “Anyone can be infected with MonkeyPox through skin-to-skin contact, sexual intercourse, skin contact with virus-laden surfaces such as bedsheets, as well as through prolonged exposure to MonkeyPox-laden aerosols and/or respiratory droplets. MonkeyPox has an incubation period of up to three weeks. During the current MonkeyPox outbreak in the US, the virus is primarily being diagnosed in the male gay community. However recent spillover has been documented in women, children and infants which raises the possibility of a wider outbreak that could make its way into broader circulation in the general population. As such, it is imperative to support the male gay community and the broader community’s mitigation efforts by making MonkeyPox testing more broadly available in ways that will allow patients to be diagnosed sooner, hopefully during the pre-symptomatic stage where intervention is likely to be most effective.”
Mr. Commissiong continued, “Currently the US has capacity to test approximately 80,000 samples per week. If we are to contain MonkeyPox and prevent it from becoming endemic to the United States, we must dramatically ramp up testing of not only lesion-based samples that require someone’s infection to become symptomatic, but also saliva-based samples that likely provides the best opportunity to diagnose patients much earlier in disease pathogenesis. Provista currently has PCR automation capacity to run 25,000 PCR tests per day, or 175,000 PCR tests per week, with ongoing efforts to increase this capacity to 50,000 PCR tests per day, or 350,000 PCR tests per week. Additionally, our supplier of materials that allowed us to quickly complete the development of our LDT has sufficient capacity to manufacture and deliver well over 1,000,000 PCR assays per week for the US market, which we intend to also deploy as needed through our Corona Diagnostics distribution arm to clients of ours and assist them with assay validation in the event there is a need for testing beyond Provista’s capabilities. The availability of this increased testing capacity and materials supply to aid in the US MonkeyPox public health emergency mitigation efforts, coupled with saliva testing for mildly symptomatic and asymptomatic individuals, will provide the opportunity to dramatically accelerate contact tracing efforts by serially testing of exposed individuals in order to give greater certainty to the individual that they are not infected or contagious, and provide the needed better opportunities to break the chains of infection.”
Concurrent with this announcement, the Company will release its 10Q quarterly financial statements for the second quarter of 2022 after market close at 4:05 pm Eastern time and hold a business update conference call on Tuesday, August 23rd, 2022 at 8:30 am Eastern time.
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/.
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.
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