Todos Medical Announces PCR Validation of Wound and Respiratory Pathogen Panels at CLIA/CAP Lab Provista Diagnostics

New York, NY, and Tel Aviv, ISRAEL , Aug. 10, 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 laboratory Provista Diagnostics has completed validation of its PCR-based Wound and Respiratory Pathogen panels. The Wound Panel (WP) is a 31-pathogen multiplexed PCR panel, including antibiotic resistance, taken from swab samples of a wound or lesion that will assist physicians in determining which combinations of drug therapies prescribed to the patient will result in the best patient outcomes. The Respiratory Pathogen Panel (RPP) is 24-pathogen multiplexed PCR panel taken from nasal or saliva samples that will assist physicians in making better treatment decisions for patients presenting with respiratory illnesses. Both the WP and RPP tests can be run on Provista’s state-of-the-art Tecan and 3D Med liquid handling automation systems that improve efficiency, safety and capacity, allowing Provista to currently perform up to 25,000 PCR tests per day. With nine (9) liquid handling systems currently onsite at Provista from former Todos PCR testing lab clients, the Company expects Provista to soon be able to run up to 50,000 PCR tests per day. Provista now has 7 Thermo Fisher PCR systems (2 QuantStudio 12k Flex, 2 QuantStudio 7 Flex, 3 QuantStudio 5) and 1 Biorad (CFX) system providing an ability to run over 2,400 patient samples at a time. The Company will continue to redeploy automation and equipment assets towards Provista as 3rd party lab testing contracts wind down.

Additionally, the Company provided an update on the validation of its MonkeyPox lesion and saliva-based assays that validation is on track to be completed in the second half of August. The Company intends to wait until the MonkeyPox validation is complete in order to commercially launch its WP and RPP tests, as it is the Company’s intention to also make MonkeyPox testing available on those samples. Given that MonkeyPox is spread primarily through skin-to-skin contact, contact with open wounds (lesions), as well as through respiratory droplets and aerosols, both with WP and RPP assays will have important clinical value for differential diagnosis.

While lesion-based testing is the current standard of care according to CDC guidelines, prospective clients have expressed eagerness to gain access to saliva-based sample collection as a means of improving the safety of frontline healthcare workers screening suspected MonkeyPox cases. Flow Health in Los Angeles, CA, a leader in MonkeyPox testing, has already reported successfully assisting in the diagnosis of asymptomatic MonkeyPox patients using saliva samples, proving saliva testing’s clinical usefulness in the current MonkeyPox outbreak. Provista MonkeyPox tests are being developed as Laboratory Developed Tests (LDTs). A recent peer-reviewed article describing strong correlation of the sensitivity of lesion and saliva-based PCR testing was recently published in the journal Eurosurveillance:

“It has become clear to us that waiting an additional couple of weeks for the MonkeyPox validations to be complete in order to move forward with the previously planned commercial launch of our wound and respiratory panels makes a lot of sense given that, just in the last couple of days, we have started to get a number of unsolicited healthcare practices enrolling as ordering physicians for Provista lab services after reading about our plans for saliva-based MonkeyPox testing,” said Gerald E. Commissiong, President & CEO of Todos Medical. “While we do have the ability to reference suspected MonkeyPox samples collected through lesion-based swabs right now to partner labs doing swab-based testing, it is clear that the most effective way to increase healthcare providers’ willingness to more broadly screen for MonkeyPox is to improve the safety of its assessment through self-administered saliva sample collection. We believe that saliva-based MonkeyPox testing will be a game-changer in our ability to track and trace infections.”

In 2021, U.S. wound and tissue management market size was valued at $10.7 billion and is expected to grow to $13.8 billion by 2028. The primary drivers of market growth were previously anticipated to be the over 65 population that has a 3-6% likelihood of venous leg ulcers. The Company believes MonkeyPox will add substantially to this market size for the second half of 2022, and potentially beyond if the United States is unable to adequately contain MonkeyPox. The Respiratory Diagnostics market in the U.S. was estimated at US$3.5 Billion in the United States in 2022 and is expected to grow to $5 Billion by 2027. This market is primarily driven by COVID-19 and COPD testing. The Company believes MonkeyPox will add substantially to this market size for the second half of 2022, and potentially beyond if the United States is unable to adequately contain MonkeyPox.

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, and Provista’s proprietary commercial-stage Videssa® breast cancer blood test.

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 pursuing the development of diagnostic tests targeting the 3CL protease, as well as 3CL protease inhibitor botanical and pharmaceutical products 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 & anti-cytokine therapeutic drug candidate Tollovir®, while also developing the 3CL protease inhibitor diagnostic TolloTest™.

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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


Todos Medical

917-983-4229 x 104

[email protected]

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