News | December 2, 2020

Todos Medical Provides Strategic Outlook

New York, NY, Rehovat, Israel, Singapore (GLOBE NEWSWIRE) - via NewMediaWire - Todos Medical (OTCQB: TOMDF), an in vitro diagnostics company focused on distributing comprehensive solutions for COVID-19 screening and diagnosis, and developing blood tests for early detection of cancer and Alzheimer’s disease, today provided a corporate update to the market, as well as an outlook for the Company as it heads into 2021.

COVID-19 Testing Sets the stage for the future
Todos recently completed the installation of two (2) Tecan® liquid handlers at its largest lab client in Wisconsin, thereby providing the lab liquid handlers in addition to automated extraction systems. After optimizing the workflows following the installation, we are confident this lab will be able to process up to 20,000 qPCR tests per day, with the lab now operating 24 hours per day, seven (7) days a week. This PCR testing capacity positions the lab to be able to increase sample inflows from its contract with the State of Wisconsin by up to 450%, which in turn will significantly increase order flow for Todos’ PCR testing consumables.

Additionally, we are preparing to complete the installation of a similar lab automation workflow process at another lab in Brooklyn, NY in the month of December, which will bring that lab’s testing capacity to 20,000 PCR tests per day. Taken together, we are demonstrating Todos’ ability to provide lab clients with automated workflows that can achieve high-throughput PCR testing capacity, coupled with the fact that this is a repeatable model that can significantly drive revenue. We intend to strategically scale existing clients and bring on new clients that have developed solid contracts for sample processing that will allow them to order large volumes of tests per day, leading to increased PCR sales for Todos.

As PCR testing continues to grow, recent advances in vaccine development will drive immune testing to understand whether immunity has been attained in individuals, either by prior COVID-19 infection or COVID-19 vaccination. Todos has established relationships with leading companies developing next-generation immune-based blood testing, and we intend to add these tests to our offering as they gain regulatory approval. Additionally, our proprietary 3CL protease test is in the final stages of testing before launch of lab-based test that will be complementary to existing PCR testing by confirming the activity status of the virus-positive patients. This assay will give better understanding of whether a patient remains contagious following quarantine or therapeutic intervention, and whether the Company’s proprietary dietary supplement Tollovid® could have an impact on the length of time a person remains infected. A clinical trial for Tollovid is being prepared in Israel.

Our business model is now set on offering genetic and immune testing reagents & kits to our clients, as the genetic testing capabilities labs are acquiring now in response to the COVID-19 crisis will allow them to expand their offerings to make available more cost-effective, scalable, genetic and immunology testing solutions to the market in the future. We believe this could drive the next wave of innovation in the US laboratory industry and give rise to better health information that will empower patients and physicians to make better decisions that will improve outcomes and reduce costs. The infrastructure required to turn the promise of personalized medicine into a reality is largely being pushed forward in response to COVID-19, and we see this as a megatrend that will continue well into the future.

We believe the mobile testing labs we have been helping advance have a similar opportunity to improve the landscape for testing in the United States by creating a proprietary outlet for novel testing solutions that will further support the nation’s testing infrastructure. Bringing testing forward in a new, more personalized way that reduces wait times and is agile enough to be deployed anywhere will survive the pandemic and will ultimately provide another key distribution channel for our testing solutions.

Todos’ Breast Cancer testing will become more central in 2021
2020 forced Todos to establish its commercial testing operations initially focused on COVID-19. As we head into a long winter where we expect cases to spike to record levels before vaccination programs can hopefully help reduce the severity of the pandemic, we are also beginning to think about the post-pandemic future and how Todos can establish itself as an important player in the diagnostic testing business for the long-term. As such, we are focused on utilizing the opportunity provided by COVID-19 testing to position for launch of diagnostic testing through the commercial outlets we are establishing now.

We intend to focus our pipeline initially on breast cancer where we are building up significant intellectual property around our proprietary TBIA/FTIR platform, and commercial infrastructure by way of the strategic acquisition of Provista Diagnostics, so that we can consolidate our commercial opportunity and optimize assay performance as we go to market in 2021 in breast cancer blood testing.

Summary
2020 has really forced Todos to focus on establishing commercial operations so that we can position the Company to capture scalable revenue in the face of steep competition. As we begin to significantly execute on the COVID revenue opportunity, we are leveraging our proprietary distribution channels in such a way that we will be able to deploy our other proprietary testing products through those channels to be able to scale our more proprietary testing solutions that could have an impact far beyond COVID-19.

We are working hard on closing out 2020 on a high note, and expect 2021 to be a transformational year for Todos as we build upon the initial commercial success we are seeing in 2020. We are excited with the opportunity before us to dramatically improve testing in the United States.

For information related to Todos Medical’s COVID-19 testing capabilities, please visit www.todoscovid19.com

For testing and PPE inquiries, please email sales@todosmedical.com .

About Todos Medical Ltd.
Headquartered in Rehovot, Israel, 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 deploys deep examination into 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 entered into an exclusive option agreement to acquire U.S.-based medical diagnostics company Provista Diagnostics, Inc. to gain rights to its Alpharetta, Georgia-based CLIA/CAP certified lab and Provista's proprietary commercial-stage Videssa® breast cancer blood test. The transaction is expected to close in the third quarter of 2020.

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.

Additionally, Todos has entered into distribution agreements with companies to distribute certain novel coronavirus (COVID-19) test kits. The agreements cover multiple international suppliers of PCR testing kits and related materials and supplies, as well as antibody testing kits from multiple manufacturers after completing validation of said testing kits and supplies in its partner CLIA/CAP certified laboratory in the United States. Todos has formed strategic partnerships with Integrated Health LLC, MOTOPARA Foundation to deploy mobile COVID-19 testing in the United States.

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 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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Source: Todos Medical Ltd.