Startup says its blood test can detect early-stage lung cancer

Israeli startup Savicell Diagnostics has jumped into the emerging market of lung cancer detection, saying its blood tests can discover signs of the disease at its initial stage.

The “revolutionary” ImmunoBiopsy test is minimally invasive and easily available in a world of rising healthcare expenditure, said the company’s CEO and president Giora Davidovits.

Lungs contain very few nerve endings and consequently register little pain. As a result, cancer found on this organ tends to be discovered late. Patients whose lung cancer is detected at stage 1 have an 80 percent chance of survival, whereas at stage 3 it goes down to 13-14%, and at stage 4, only about 4% survive, according to Davidovits.

Through medical imaging, a radiologist can identify scars, or so-called lung nodules, but their existence and size are not necessarily indicative of their potential malign state.

“Even in high-risk patients [like heavy smokers], if you see a scar, the chance is that it’s not cancer but a benign lesion,” said Dr. Amir Onn, head of the Institute of Pulmonology at Sheba Medical Center in Tel Hashomer.

An illustrative image of a doctor with radiological chest x-ray film (Chinnapong; iStock by Getty Images)

A definitive diagnosis of lung cancer is traditionally obtained via biopsy, in which a cell sample is taken from the area close to the tumor and examined in the laboratory.

This intervention, under anesthesia, is still considered risky and relatively costly and not readily available everywhere. It is also not always possible, for example in cases of collapsed lungs or other scenarios where the lungs cannot be reached.

An alternative has emerged in the form of a so-called liquid biopsy, in which bodily fluids such as blood or urine have been used to reveal diseases.

Giora Davidovits, CEO and president of Savicell Diagnostics, left, and Eyal Davidovits, chief operating officer (Courtesy)

Europe — mostly Germany, the UK and France — and North America are the fastest-growing markets in this new trend of detecting tell-tale cancer markers in blood or urine, according to Zion Market Research, which also said that the global market generated $1.2 billion in 2018 and is expected to go up to $12.1 billion in 2025.

While other research companies engaged in the development of liquid biopsies have focused on sequencing DNA material from a patient’s blood, Savicell has adopted a completely different approach.

“We look at the metabolic profile of the immune system,” Davidovits told The Times of Israel.

When a cell starts degenerating, the immune system is the body’s natural first responder, activating changing sources of energy — or metabolic reactions — to get rid of the intruding malignancy.

According to Savicell, the immune system produces different metabolic reactions for each disease, and it is these metabolic shifts that the startup monitors.

Third-party published studies show that the firm’s ImmunoBiopsy blood test can distinguish “between and within various ailments, such as cancers, autoimmune diseases and infectious diseases,” the firm said.

Savicell developed what it calls Well Shield technology, in which various biological stimulants are brought together with patient’s blood cells on a “Well plate” to study their interactions.

In a 2018 study published in the academic journal Cancer Immunology and Immunotherapy, Savicell tested the blood of 200 patients — of whom half were “healthy” control subjects and the other half had an equal distribution of various stages of lung cancer.

The study revealed that in 91% of the cases, the blood test could identify cell malfunction and it did so equally well at every stage. In 80% of the cases, healthy people were identified as healthy.

“With 32% at stage 1, the study showed that our ability to detect lung cancer at early stages is as good as detecting it at a later stage,” said Davidovits. “That’s the power of our platform, and the key difference between us and other companies.”

Savicell has already developed a test for breast cancer, but is currently focusing on lung cancer, where it has a more advanced product.

The testing has so far been conducted at leading Israeli hospitals, such as Carmel Medical Center in Haifa, where the company has its headquarters, and Rambam Health Care Campus in Haifa, as well as Ichilov Hospital in Tel Aviv.

A competitor in the field of liquid biopsy and early detection of lung cancer is the Israeli firm Nucleix Ltd., a research institute in Rehovot. Nucleix can tell in 74% of cases if someone has cancer, and in 91% of cases, it identifies healthy patients. The firm uses DNA sequencing as opposed to looking at the immune system’s responses for its diagnosis.

All these new technologies that look at how cancer cells affect their surroundings, however, still have considerable limitations, according to Sheba’s Onn.

“Savicell’s blood test can recognize lung nodules with a size starting from 7 millimeters, which is fine, but the ultimate goal is something like 2 millimeter,” he said. “The method is very promising, but the problem is that it’s not yet sensitive and accurate enough.”

Professor Yochai Adir, chairman of the Israeli Association for Lung Disease said: “Based on the findings of clinical research we conducted, Savicell Diagonostic’s  test is a promising breakthrough for detection of lung cancer (I, II), a leading factor for lung mortality. More importantly, the test has high sensitivity (92%) and specificity (76%) in detecting lung cancer at early disease stages (I, II), and in our test new appearing lung nodules were as small as 3mm.”

When a CT scan detects a large nodule of 1 centimeter or more, the first go-to method is still the regular biopsy, Onn said.