Todos Medical Initiates Validation Plan for PCR-based Polio Testing at CLIA/CAP Laboratory Provista Diagnostics

Rhea-AI Summary

Todos Medical, Ltd. (OTCQB: TOMDF) announced that its CLIA/CAP-certified laboratory, Provista Diagnostics, has initiated a validation plan for PCR-based polio testing. This includes developing low viral load diagnostic tests for early detection. The global bioinformatics market is expected to grow from $13.2 billion in 2021 to $45.6 billion by 2030. Todos emphasizes that wastewater surveillance is pivotal for controlling the spread of viral pathogens. The company also focuses on expanding diagnostic solutions for various diseases, including cancers and neurodegenerative disorders.

Positive

• Initiation of a validation plan for PCR-based polio testing.
• Development of low viral load diagnostic tests for early diagnosis.
• Participation in the growing global bioinformatics market, projected to reach $45.6 billion by 2030.
• Expansion of diagnostic solutions across multiple disease areas, including cancers and neurodegenerative disorders.

Negative

• None.

• Follows CDC & World Health Organization's (WHO) announcement that US now meets criteria for country with circulating vaccine-derived poliovirus (cVDPV)

• Surveillance wastewater and patient diagnostics testing planned

New York, NY, and Tel Aviv, ISRAEL , Sept. 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 laboratory Provista Diagnostics has initiated a validation plan for PCR-based polio testing. The Company intends to validate multiple PCR assays for polio, including wastewater testing with ultra-high sensitivity. Low viral load diagnostic tests will be developed for early diagnosis and will be available for multiplexing with our other PCR panels.

The global bioinformatics market was valued at $13.2 billion in 2021 according to Precedence Research and is expected to grow at a CAGR of 16.3% to $45.6 billion by 2030. This market includes data management and production, data warehousing, and data mining for life sciences, academia, and applied testing.  A much smaller subset of this market is the Wastewater-based epidemiology (WBE) which surveils large population clusters in an unobtrusive manner. The routine testing can be used to capture data on underreported viral illnesses, enabling the early detection of pathogens in a community.  There are 58 countries gathering this data in order to enact policy decisions. During the COVID-19 surges, wastewater patterns were analyzed and became predictive of the subsequent outbreaks. The average site typically screens weekly or twice weekly and gets reimbursed up to $940 per site per week according to some recent awards from the CDC. 
  
“Wastewater surveillance has become a powerful tool that needs to be implemented systematically nationwide now that COVID, MonkeyPox, and Polio are circulating in the United States,” said Gerald E. Commissiong, President & CEO of Todos Medical. “Surveillance testing is an essential tool in controlling the community spread of these emerging viral pathogens. The lack of funding support for widespread testing makes wastewater surveillance our first line of defense in the detection of outbreaks.  Given the tremendous value of wastewater testing data, policymakers could use it to enact COVID mitigation efforts, therefore we felt it was important for us to be able to offer this service to our emerging customer base for our Long COVID, UTI, Respiratory, GI, Wound and STD PCR panels.”

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. Provista has also soft-launched multiple PCR-based assays including MonkeyPox, Urinary Tract Infection, Gastrointestinal (GI), Respiratory Pathogen and Wound. panels 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 is Todos Medical's latest initiative regarding polio testing?

Todos Medical has initiated a validation plan for PCR-based polio testing at its CLIA/CAP-certified laboratory.

How is Todos Medical addressing the current circulating viruses in the US?

TOMDF is utilizing wastewater surveillance as a method to monitor and control community spread of emerging viral pathogens.

What is the projected growth of the bioinformatics market relevant to Todos Medical?

The global bioinformatics market is expected to grow from $13.2 billion in 2021 to $45.6 billion by 2030.

What new diagnostic tests is Todos Medical developing?

Todos is developing low viral load diagnostic tests for early detection of polio, along with other tests for diseases like cancers and neurodegenerative disorders.