The I-Chip is a small disposable microarray that looks much like the chips used by the electronic industry, but contains biological molecules instead of circuitry.Dr. Eli Sahar, CEO of Immunarray, makes no bones about it.“Lung cancer is one of the …
“Lung cancer is one of the most lethal cancers,” he says. The second most common cancer in terms of annual incidence, it has a five-year survival rate of just 15%. When you consider that there are 1.25 million new cases of lung cancer diagnosed every year worldwide, and 175,000 in the US alone, you get a picture of just how devastating this illness can be.
The sad truth is that many more people could survive this illness if it were only diagnosed at an early stage.
“Lung cancer usually develops unnoticed and is diagnosed only after symptoms have already appeared. By the time a patient starts coughing up blood in their sputum it’s too late. The cancer has progressed too far,” Sahar told ISRAEL21c.
Immunarray could help alter these figures. The small eight-man start-up is working on a simple new and inexpensive blood test, called the I-Chip, which promises to diagnose lung cancer, and a host of other diseases, even at the earliest stages. The impact of this could be profound. When lung cancer is diagnosed at an early stage, surgical treatment increases the five-year survival rate to over 90%.
Immunarray’s technology takes its cue from the human immune system. “The immune system has many functions, from wound healing, to tissue regeneration and waste disposal,” explains Sahar. “In order to program these functions it must know what is happening to the body. Basically it’s like a reporter, surveying the body at all times. If a change occurs, or a disease develops, the immune system senses these changes in real time and reacts appropriately, creating antibodies to fight the illness.”
With this in mind, Immunarray is developing a micro-array chip that can profile the immune system and diagnose diseases by identifying the anti-bodies in the bloodstream.
“Every disease has its own antibody signature and if we examine these in detail they serve as a marker for the disease,” says Sahar, a physicist and former professor of biotechnology at Tel Aviv University.
The I-Chip is a small disposable microarray that looks much like the chips used by the electronic industry, but contains biological molecules instead of circuitry. Each chip can carry thousands of different molecules on it, though initially the company plans to create chips that test for just one disease at a time. To do this, you just take a drop of blood, put it on the chip, and if the relevant antibodies are present in the blood they will bind to the chip creating a signature that profiles the patient’s state of health.
“We detect this bonding and measure the concentration of antibodies in the blood thereby identifying whether in individual has the disease or not, and at what stage the disease is at,” says Sahar.
While this is a platform technology that can be used to identify any number of auto-immune and inflammatory diseases, including juvenile diabetes, multiple sclerosis, rheumatoid arthritis, cancer and Crohn’s disease, Immunarray decided to focus first on lung cancer because of its prevalence, its deadly nature, and also because there is an easily identifiable population at risk of the disease.
In the vast majority of cases – some 85 percent – lung cancer is a result of smoking. In the US, there are 19 million current or past smokers over the age of 45, the age at which lung cancer incidence rises. These high-risk smokers form a well-defined target population for the I-Chip cancer test, which is particularly well suited for screening of large populations.
“If we gave everyone who is a heavy smoker a simple blood test early on we could find and treat the lung cancer at an early stage,” says Sahar.
This is undoubtedly a huge undertaking, but there is much evidence to suggest that early screening would soon be reimbursed by the health authorities. Even if it was not, the $100 test is affordable enough for smokers to pay for by themselves. And who wouldn’t like the chance to detect and treat an illness before it became life threatening?
Up to now Immunarray has carried out in-house proof of concept trials using specimens collected over the years from Israeli and US labs including leading cancer center, MD Anderson in Houston, Texas. Results, according to Sahar, have been excellent.
“We have identified patients with lung cancer even at the earliest stages of development,” he says.
The company is now finalizing development, which is likely to take another 18 months. This will be followed by clinical trials at three different sites in the US. Sahar expects the first version of the test to reach the market with the help of a strategic partner by the end of 2009. The US is the company’s first target market.
At present patients who are at risk from lung cancer must undergo either an X-ray or a CT scan. These are non-specific and relatively expensive tests. If a suspicious nodule is discovered then the doctor will carry out a biopsy or surgery, and the final diagnosis will be done based on that.
Sahar believes that the I-Chip will not replace these methods, but precede them. Patients who get a positive response on the blood test, will then go on to do a CT scan, and follow the normal treatment path.
Immunarray was founded in October 2005. The original technology was developed by two professors at the Weizmann Institute in Rehovot, the world-renowned immunologist Prof. Irun Cohen and Prof. Eytan Domani, who worked on it for 10 years before the company was set up to commercialize their work.
The private company is part of the RAD BioMed Incubator in Tel Aviv. In October it leaves the incubator and is presently looking for funding of $2.5 million to help it finalize development and begin clinical trials.
In the meantime, the company is also carrying out R&D on early-stage blood tests for other diseases, particularly those of the immune system. “Again, we’ve had very promising results,” says Sahar.
In principle, one chip could be used to diagnose several diseases, but each disease requires clinical development and trials so the company is focusing now on developing chips that identify just one disease at a time. “The main effort of our R&D today is to find the right signature for each illness,” he explains.
“We are at an early stage, but we are very optimistic,” Sahar adds. “The immune system is a very powerful tool and we have developed a really unique approach. We meet a critical need that is currently unmet. The possibilities are enormous.”