Todos Medical Enters Into Letter of Intent for Provista Diagnostics to License PCR-based Sepsis Diagnostic Test AcuSept LDT Rights From Acumen Diagnostics

Rhea-AI Summary

Todos Medical, Ltd. (OTCQB: TOMDF) announced a letter of intent with Acumen Diagnostics to license the rights for the sepsis PCR-based diagnostic test AcuSept® in the U.S. This test identifies 19 mRNA biomarkers related to infection and sepsis and can yield results within 5 hours. Sepsis, having dire consequences in hospitals, costs the U.S. healthcare system over $62 billion annually. AcuSept has shown superior sensitivity compared to existing tests, aiding in the early diagnosis of sepsis. Provista Diagnostics will conduct clinical validation studies to support FDA submissions.

Positive

• Licensing of AcuSept® diagnostic test has potential to improve sepsis detection in the U.S.
• AcuSept® can provide results within 5 hours, significantly enhancing patient care.
• Superior sensitivity of AcuSept® compared to other tests may lead to better patient outcomes.

Negative

• None.

New York, NY, Alpharetta, GA, Tel Aviv, ISRAEL and SINGAPORE, March 28, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced it has entered into a letter of intent with Acumen Diagnostics Pte Ltd of Singapore for its CLIA/CAP-certified clinical testing lab Provista Diagnostics to license the laboratory developed test (LDT) rights to commercialize the sepsis PCR-based diagnostic test AcuSept® in the United States. AcuSept is a host (patient) immune response test that identifies 19 mRNA biomarkers of infection, sepsis and septic shock, and can be used to monitor patient response to treatment. Under the terms of the agreement, Provista will also conduct clinical validation studies on AcuSept® to generate the data in the United States to support Acumen Diagnostics’ 510(k) submission to the US Food & Drug Administration.

According to the Sepsis Alliance, sepsis is the #1 leading cause of death in hospitals in the United States, has an economic cost to the US healthcare system of at least $62 billion annually and is the leading cause of US hospital readmission. Hospitalized COVID-19 patients are 300% more likely to develop septic shock as compared with hospitalized influenza patients. The risk of developing septic shock increases 4-9% per undiagnostic hour of sepsis.

AcuSept can provide a sepsis result within 5h of patient sample collection; clinical studies conducted by Acumen Diagnostics had shown that AcuSept detected sepsis with superior sensitivity when compared with other single-biomarker tests, and proved to be exceedingly effective in diagnosing culture-negative sepsis. AcuSept detected infection in patients with superior positive and negative predictive values, providing complementary data to pathogen identification tests, including PCR-based tests Provista currently offers, that will allow physicians to have a more comprehensive view of a patient’s condition that will enable for better targeted, faster treatment decisions.

“Sepsis presents a huge human and economic toll on the healthcare system as the #1 cause of death in hospitals,” said Gerald Commissiong, President & CEO of Todos Medical. “As Provista expands its pipeline of proprietary tests it intends to launch via the Laboratory Developed Test (LDT) pathway in the United States, our growing salesforce is very excited to work with hospitals and long-term care facilities to improve the screening and diagnosis of sepsis, thereby allowing for earlier therapeutic interventions that have greater benefit at the earliest stages of sepsis that reduce the likelihood of a patient undergoing septic shock. In this era of COVID-19 and widespread antibiotics resistance, we believe that sepsis has become an even more urgent medical challenge, and that it may also play a role in the worst outcomes of Long COVID. After an extensive evaluation of technologies to diagnose sepsis, we came to the conclusion that AcuSept has potential to contribute in an impactful way to fulfill this important unmet need of improved sepsis diagnosis.”

“We are very excited to partner with Provista to bring our AcuSept test to the United States,” said Dr. Ong Hwa Siew, CEO of Acumen Diagnostics. “We spent several days with the Provista team, evaluating their lab capabilities and meeting with physicians in Atlanta regarding the deployment of AcuSept® to assist with the screening and diagnosis of sepsis in long-term care facilities, urgent care centers and hospitals. It was clear that the Provista team is well-integrated into the Atlanta healthcare community and has the necessary relationships to execute a successful launch of AcuSept in the United States.”

For more information, please visit todosmedical.com. For more information on the Company’s 3CL protease inhibitor dietary supplement that provides immune support with 3CL protease inhibition. please visit www.mytollovid.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://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.

Todos Corporate and Investor Contact:
Gerald Commissiong
President & CEO
gerald@todosmedical.com

FAQ

What is the significance of Todos Medical's deal with Acumen Diagnostics?

The deal allows Todos Medical to license the AcuSept® test for sepsis diagnosis, which has significant implications for improving patient outcomes in the U.S.

How does AcuSept® improve the diagnosis of sepsis?

AcuSept® detects 19 mRNA biomarkers, providing results within 5 hours, thereby allowing for faster diagnosis compared to traditional methods.

What are the financial implications of sepsis in the U.S. healthcare system?

Sepsis is the leading cause of death in hospitals, costing the U.S. healthcare system over $62 billion annually.

What are the next steps for Todos Medical regarding AcuSept®?

Provista Diagnostics will conduct clinical validation studies to support Acumen Diagnostics' 510(k) submission to the FDA.

How does AcuSept® compare to other sepsis diagnostic tests?

Clinical studies indicate AcuSept® has superior sensitivity and predictive values, making it more effective in diagnosing sepsis.