Abigail Klein Leichman
September 24, 2013

For people suspected of having Helicobacter Pylori (H. Pylori) bacteria in their system, the best feature of the newly launched BreathID Hp diagnostic device is that they don’t have to do anything but breathe.

Larry Cohen, CEO of the Israeli company Exalenz Bioscience, maker of the machine, explains how the continuous monitoring device works.

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“We hook up two small tubes to the patient’s nose, and the patient just breathes normally a few minutes. Then he drinks a cocktail of urea and citrica, an activator for the test, and in a few minutes the results come out on the printer and screen. That’s all the patient has to do, and the operator doesn’t have to do anything other than push a button.”

According to the Centers for Disease Control, about two-thirds of the world population is affected by the H. pylori bacteria, which causes peptic ulcers and gastric inflammation, and is associated with stomach cancer. The most common way to detect this type of bacteria is a blood test.

“In the US, there are 4.2 million blood tests for H. pylori every year, and that is invasive and takes days to get results,” Cohen tells ISRAEL21c from the company’s New Jersey office, which is handling the global launch of this 99 percent accurate “test and treat” device.

“In our test, everything is done within 10 to 15 minutes, and if the results are positive, patients go home with a prescription for antibiotics. If the results are not positive, the physician can immediately do other tests to find the cause of the problem.”

Molecular breath testing is an increasingly popular, noninvasive way to help doctors quickly and accurately diagnose conditions including H. pylori, lactose or fructose intolerance, and bacterial overgrowth syndrome.

The approach has been used in the diagnosis of H. pylori for the past decade, says Cohen.

Continuous monitoring

The BreathID platform innovated by Exalenz is approved for use in Europe and the United States. Now in more than 220 US centers, and holding the major share of the market in Israel, it offers several advantages over systems made by Japanese and American competitors.

“Ours is highly efficient because it is over 99 percent accurate and you can get fast results,” Cohen says. “The continuous monitoring mode is a novel element to our test. We are the only company that offers that, and we hold the intellectual property so we will maintain our exclusivity.”

“The nice thing is we get continuous interpretation of the urea level inside the patient, so I know in real time if they’re infected,” says Dr. Andrew Meltzer of the emergency department at George Washington University Hospital in Washington, DC. “We’ve used it a lot over the past two years in the ER.”

Other breath diagnostic systems require the patient to blow into a bag, drink the activating cocktail and then blow into another bag. The contents of each bag must then be analyzed individually.

Meltzer tells ISRAEL21c, “As far as I know, BreathID is the quickest, smallest and most facile breath test of its kind. Blood tests and even other breath tests have to be sent to a lab, but with this device the patient sees a printout in 10 minutes.”

BreathID Hp is non-regulated, so any healthcare professional can be trained to operate it by following screen-displayed directions. “We’ve had research assistants and medical technicians using it with minimal training,” says Meltzer.

He also points out that BreathID’s tabletop device uses a non-radioactive isotope in its “cocktail,” unlike others that expose the patient to radioactive isotopes.

Smaller, easier to operate

A newly hired US sales force is demonstrating the machine to physicians who currently use blood tests to check for H. pylori, and former J&J executive Ted Foltyn has joined Exalenz as vice president of worldwide marketing and business development.

Meltzer agrees there is a need for provider education. “I would say most gastroenterologists are aware of BreathID, but most ER and primary-care physicians are not,” he says. “Once people realize they can do a test at bedside and have other than a doctor or nurse administer it, I think they’ll start using this device in other settings.”

The system can also be used to test if the H. pylori bacteria have been eradicated. Testing costs are reimbursable by Medicare, Medicaid and most other payers.

Exalenz also is sold in South America, where the Israeli product has found an advocate in Dr. Henry Cohen of Uruguay, president of the World Gastroenterology Organization. Discussions are being held with potential partners in a few European countries and in China.

Though detecting H. pylori is the main job of the machine, it can be used with different software to test for other conditions via breath analysis.

“We have two liver tests under development that we anticipate will be going to clinical trials next year,” says Cohen.

All components of the system are made in Israel. The growing company employs 38 people in Modi’in, in central Israel. Its American branch is expected to include about 20 employees by year’s end.

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