Savicell Diagnostics Achieves Breakthrough in Early Detection of CancerImmunoBiopsy™ platform achieves high accuracy; 97% sensitivity and 97% specificity in lung cancer, including at stage I

HAIFA, Israel, Sept. 09, 2021 (GLOBE NEWSWIRE) -- Savicell Diagnostics Ltd., a wholly owned subsidiary of Online Disruptive Technologies Inc., is pleased to announce it has achieved high accuracy identifying lung cancer across all its stages (I to IV) through its liquid ImmunoBiopsy™ platform. Savicell’s first-in-class liquid ImmunoBiopsy™ utilizes a non-invasive blood test to measure the metabolic state of the immune system and it acts as a diagnostic to identify early disease states.

In a cohort of 245 participants, the ImmunoBiopsy™ achieved 97% sensitivity and 97% specificity among patients with lung cancer. Importantly, even at stage I sensitivity was 97%. A more detailed analysis of the cross validated study results is available in a new study report available on the Company’s website: http://www.savicell.com/publications.html

Savicell’s liquid ImmunoBiopsy™ platform offers a number of advantages, including:

• High sensitivity and specificity
• Easy administration through a simple blood test
• Safe and cost-effective
• Results in hours
• Earlier detection of cancer saves lives

In comparison, other blood-based diagnostic cancer tests are focused on detecting circulating biomarkers, such as tumor DNA, tumor antigens, tumor cells, exosomes, or extracellular vesicles. These biomarkers are released into the blood, primarily when the tumor reaches a certain size in a later stage of the cancer. Unfortunately, the tumor growth required to detect cancer using many of these tests seem to make them less effective in detecting early stage cancer (stage I).

Similarly, while diagnostic imaging methods, such as a computed tomography (CT) scan, low-dose CT scan (LDCT), and radiography, all have high sensitivity and were shown to save lives, they have low specificity, with false positive rates of 96.4% for LDCT and 94% for radiography. In turn, this often leads to a large number of unnecessary follow-up procedures. These procedures are expensive, invasive and can have significant complication risks.

The combination of low dose chest CT scans with the liquid ImmunoBiopsy™ platform may also reduce the need for follow-up screening of suspected lung nodules, preventing unnecessary radiation exposure and may decrease the number of unnecessary invasive procedures with their associated complications. In addition, the ease of the ImmunoBiopsy™ test for lung cancer may help improve adherence to routine medical screenings in high risk populations.

Giora Davidovits, CEO of Savicell, commented, “These results mark a breakthrough in the fight against cancer and are an important validation of our liquid ImmunoBiopsy™ platform as illustrated by the high specificity and sensitivity. The ability to detect cancer early is often the difference between life and death. There is a major unmet need for a safe and cost-effective liquid biopsy test that can help screen patients for early signs of cancer through the use of a patient-friendly blood test. While our ultimate goal is early screening of the broader population, our immediate focus is to utilize this technology to assist physicians in the diagnosis of indeterminate nodules and help to significantly reduce the number of false positive results. As a next step, our goal is to help screen at-risk patients, such as smokers and former smokers, for early signs of lung cancer. The broad potential of this immunometabolism-based platform may also allow us to extend it to other types of diseases, as well as for use in treatment monitoring and therapy selection.

I would like to thank everyone involved in the development of our platform and completion of this trial, including our immunology and data science teams who worked tirelessly to fine tune and enhance our already very capable platform. We believe these results illustrate the importance of our test and its potential to contribute to the global fight against cancer.”

Shafrira Shai, Executive VP of R&D, stated “Savicell’s liquid ImmunoBiopsy platform monitors ex vivo cellular immune responses to antigenic stimuli within a few hours to determine whether the cells respond to each specific stimulus. These are extremely encouraging results and, to date, there is no other laboratory test we are aware of that provides such quick and accurate results.”

Study results

About Savicell

Savicell’s first-in-class liquid ImmunoBiopsy™ platform non-invasively measures the metabolic state of the immune system and acts as a diagnostic link to early disease states. The field of “immunometabolism” is rapidly emerging. It is driven by the discovery that the normal metabolic state of the immune system is linked to its ability to combat infectious disease and cancer. Savicell is at the forefront of this emerging field and is currently focused on developing diagnostics in this space.

One of the most important recent discoveries is that immune system cells alter their energy generation in order to obtain an effector function. In other words, T cells change their pathways to create metabolic energy (ATP molecules) to enable them to kill cancer. T cells, as a pre-step to their activation state, shift pathways to create metabolic energy, moving from the oxidative phosphorylation cycle into a glycolysis cycle. Stimulation of T cells by these antigens takes place only when these cells were previously exposed to these antigens in the body. This shift into the glycolysis cycle enables faster production of energy for immediate utilization than in other energy cycles.

Savicell’s ImmunoBiopsy platform detects the metabolic change that occurs in the T cells metabolic pathways. The initial immune response to disease is intricate, deploying different metabolic pathways and subtypes of cells. The detection method is based on in-vitro recognition between T cells and disease-specific protein particles (synthetic peptides). In early disease (like cancer), T cells are exposed to disease specific protein particles. In the lab these T cells (from blood samples) are exposed to cancer-specific protein particles (synthetic peptides that replicate those that are specific to the disease/condition). Savicell then measures and profiles the resulting disease-specific shift to the glycolysis cycle. These differential metabolic responses of the immune system provide unique capability for early detection.

Initially, Savicell is focused on the multibillion-dollar cancer diagnosis market. If cancer is found at an early stage, when it is small and before it has spread, people have a better chance of survival. In contrast to existing liquid biopsy technologies that evaluate secretions of cancer cells, the ImmunoBiopsy™ platform derives data directly from the immune system, which Savicell believes will provide earlier detection than that available from existing approaches. Additional information about the company is available at: http://www.savicell.com/.

Notice Regarding Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Forward-looking statements in this press release include that our technology is designed to be deployed for early detection of diseases; that our technology may have additional applications in drug response monitoring for therapies that impact immune response, that the ImmunoBiospy™ technology is designed to detect and interpret differential metabolic responses; that we can develop a safe and cost-effective liquid biopsy test that can help screen patients for early signs of cancer through the use of a patient-friendly blood test;; and that we have patent protection on our technology. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug and treatment discovery and development, which include, without limitation, the potential failure of development candidates to advance through clinical studies or demonstrate safety and efficacy in clinical testing; our ability to retain key employees; our ability to finance development; and our ability to satisfy the rigorous regulatory requirements for new medical procedures. Good results in small trials and among limited cases does not necessarily lead to the same good results for large numbers or in the general public. Competitors may develop better or cheaper alternatives to our products. Having patented technology does not guarantee that our patents may not be challenged, or that we may be infringing on the intellectual property of others. We may not be able to commercialize our product and even if we do, we may not realize any profit. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and we undertake no obligation to revise or update this press release to reflect events or circumstances after today’s date. Readers should also refer to the risk factors disclosure outlined in our periodic reports filed from time-to-time with the Securities and Exchange Commission.

Contact for Savicell Ltd.
Crescendo Communications, LLC
Tel: 212-671-1021
Savicell@crescendo-ir.com