The biotechnology industry has still not given up on its dream of a blood test for early diagnosis of cancer, avoiding invasive tests and discomfort for the patient. Several companies are currently working on development of such a product, and one of these is Israeli company Savicell.
Savicell's product is different in that it is based on a new exciting field of research - immuno-metabolism, changes undergone by cells in the immune system in their encounter with certain diseases factors. The changes are usually in how energy is utilized within the cell - in their metabolism.
The immune system cells that undergo changes in this case are not antibodies (the cells that give us our resistance to viruses that we have already encountered); they are "killer cells." They are adapted to a specific disease and the metabolic changes they undergo are also disease specific and that affects their ability to cope with it.
"The really interesting discovery in the field, which has already been published in a very long article in "Nature Review," is that the metabolic activation is specific to each disease," says Savicell founder, president, and CEO Giora Davidovits. "This article, which was published by international researchers with no connection to our company, gives additional support for the use of this method as a broad diagnostic tool for various diseases."
The technology on which Savicell's product is based was developed at Tel Aviv University by Prof. Fernando Patolsky, and the information about it reached co-founders and brothers Giora and Eyal Davidovits (COO) after they had founded a consultancy firm in Israel in 2008. Before that, Giora was an executive in consumer products company Procter and Gamble and in drug company Johnson & Johnson, and he managed a diabetes startup. Eyal's background includes project, budget, and operations planning at Intel.
"Globes": What is the difference between you and other companies in the field?
Eyal Davidovits: "Other companies focused on activating immune system cells as part of the therapeutic process. We're the only ones, to the best of my knowledge, to use this for diagnosis, and we have patents on it."
What is the difference between Savicell and companies that offer a "liquid biopsy" - cancer diagnosis in a blood test or secretions?
Giora Davidovits: "Liquid biopsy is already a multi-billion dollar industry. Mergers and acquisitions deals totaling $6 billion have taken place in it in recent years. The difference lies in our test's sensitivity, which makes earlier diagnosis possible. Our competitors focus mainly on sequencing technologies of genetic material that the cancer secretes to the blood and other body fluids. These technologies are important to help profile the cancer but they have difficulty in detecting cancer at early stages like stage I or II. In order to do that, they have to locate extremely small cancer genetic material secreted into the bloodstream. Then they have to be able to do genetic sequencing for these materials, and to distinguish between a cancerous cell and ordinary source."
The first product that the company is developing is for diagnosing lung cancer - a type of cancer in which early diagnosis is critical for treatment. If the cancer is detected at Stage I, the survival rate is 80%, compared with 13-14% if it is detected at Stage III.
Today, most of those diagnosed at Stage I have no symptoms; they go for treatment following a random finding in an image taken for another purpose. When a nodule is seen in in an image, there are two possibilities: send the patient for a biopsy in order to determine what it is, or wait and see whether the finding changes with time. The reason for postponing the biopsy is that the procedure itself is risky. Sometimes, however, postponement of an invasive procedure makes the diagnosis too late. Replacing the biopsy with a non-invasive diagnosis is therefore critical.
Savicell's test is a kind of diagnostic kit with rows upon rows of tiny wells containing various materials that can generate a response to the immune system cells. The company measures the rate at which energy is used in the encounter of any stimulant material with the immune system cells, and describes the cell's "energy signature." "It's like a police lineup. What the cell saw in the past will raise a red flag," Eyal Davidovits says.
The product has not yet received approval from the US Food and Drug Administration (FDA), but in the US market, a laboratory test can be sold after being authorized as a CLIA laboratory, and Savicell intends to go to the FDA later. Meanwhile, it has conducted a clinical trial in Israel, the results of which were published in the journal "Cancer Immunology and Immunotherapy". The trial showed that the test's level of sensitivity (identification of patients as patients) was 91%, and its specificity (identification of healthy people as healthy) was 80%. These results are considered excellent for early diagnosis, and raise hope for the future.
Published by Globes, Israel business news - en.globes.co.il - on June 25, 2019
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