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Todos Medical Announces Saliva-Only MonkeyPox Testing at CLIA/CAP Clinical Lab Provista Diagnostics

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Todos Medical, Ltd. (OTCQB: TOMDF) announced its Atlanta-based laboratory, Provista Diagnostics, is now offering saliva-only MonkeyPox testing. Samples must be refrigerated within an hour of collection and arrive at the lab within 72 hours. Results are available in 24-48 hours, achieving a sensitivity of 1.2 viral copies per reaction. The test is primarily for suspected cases without lesions. Marketing efforts are underway to inform Atlanta school districts about testing capabilities. The Provista saliva test is available nationwide, excluding New York, where testing is anticipated post-inspection.

Positive
  • Launch of saliva-only MonkeyPox testing at Provista Diagnostics, potentially enhancing early outbreak detection.
  • Sensitivity achieved at 1.2 viral copies per reaction, indicating effective testing capabilities.
  • Sales outreach to school districts in Atlanta could drive demand for testing services.
Negative
  • Testing is not yet available in New York, limiting market reach.
  • Reliance on timely collection and shipment may affect testing efficiency.
  • Lab Reaching Out to Georgia-based School Administrators to Assist with Outbreak Plans

NEW YORK, NY and TEL AVIV, Israel, Aug. 26, 2022 (GLOBE NEWSWIRE) -- via NewMediaWireTodos 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. is now offering saliva-only MonkeyPox testing. The saliva-based samples collected must be stored in the refrigerator within 1 hour of collection and be shipped with cold packs to arrive at the lab within 72 hours of sample collection. The lab has a result turnaround time of 24-48h from the time the sample arrives at the lab. The sensitivity achieved for the saliva-based MonkeyPox laboratory-developed test (LDT) is 1.2 viral copies per reaction (0.12 copies/ul). The saliva test is intended to be used primarily in suspected cases of MonkeyPox without lesions. In cases where patients with suspected MonkeyPox present with lesions, it is still recommended to test both lesions and saliva to determine whether the lesions contain virus and whether saliva is representative of systemic active infection. The Company’s sales representatives have begun reaching out to school districts in the Atlanta, Georgia area to make them aware of Provista’s saliva testing capabilities. The Provista saliva MonkeyPox test is available in all states, with the exception of New York. The Company expects to be able to offer MonkeyPox testing in New York following a late September inspection by the New York Department of Health (NYDOH).

“We believe the scaling up of pre-symptomatic MonkeyPox testing, before lesions fully develop that can be swabbed, represents a game-changing event in the nation’s ability to contain outbreaks of MonkeyPox,” said Gerald E. Commissiong, President & CEO of Todos Medical. “As a parent of a school age children, I would want to know the school had a plan to test everyone if there was even one case of MonkeyPox to get a handle on community spread.  For decades MonkeyPox has not affected the United States because of quick containment.  While there are challenges containing the spread outside the walls of the schoolyard, we have the tests available right now that could potentially identify community spread very early and mitigate the risks to our children. We owe it to our school age children to keep them safe because kids are at increased risk of severe outcomes from MonkeyPox.”

Provista is now also preparing to validate blood testing for MonkeyPox IgM/IgG antibodies, including collection using finger prick collection devices, as well as validating MonkeyPox fecal samples to identify potential viral persistence after resolution of acute MonkeyPox symptoms.

For more information on MonkeyPox Testing or case study enrollment please contact: customerservice@provistadx.com.

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:
Kyle Kappmeier
JConnelly
Vice President
973-975-7827
kkapmeier@jconnelly.com


FAQ

What new testing service is Todos Medical offering?

Todos Medical has launched saliva-only MonkeyPox testing through its laboratory, Provista Diagnostics, in Atlanta.

What is the sensitivity of the saliva-based MonkeyPox test?

The saliva-based MonkeyPox test has achieved a sensitivity of 1.2 viral copies per reaction.

Where is the MonkeyPox test available?

The saliva MonkeyPox test is available in all states except New York, with plans to extend availability after regulatory inspection.

How quickly can results from the MonkeyPox test be obtained?

Results from the saliva MonkeyPox test can be expected within 24-48 hours of the sample arriving at the lab.

Is Todos Medical reaching out to schools regarding MonkeyPox testing?

Yes, Todos Medical's sales representatives are contacting school districts in the Atlanta area to inform them of the new MonkeyPox testing capabilities.

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