Test which helps prevent peptic ulcers, gastric cancer wins FDA approval

The BreathID performs a breath test designed to enable physicians to test, obtain results and begin treatment in a single office visit. A new device that easily tests for bacteria which causes peptic ulcers and gastric cancer developed by the …

The BreathID performs a breath test designed to enable physicians to test, obtain results and begin treatment in a single office visit. A new device that easily tests for bacteria which causes peptic ulcers and gastric cancer developed by the Jerusalem-based company Oridion, has received final FDA marketing clearance.

The BreathID device tests for bacteria called Helicobacter pylori. This bacteria is a leading cause of peptic ulcers. The bacterium is also a major risk factor in the development of gastric cancer in patients suffering from dyspepsia. The bacterium infects over half of the world’s population, including sixty million Americans.


The device performs a breath test designed to enable physicians to test, obtain results and begin treatment in a single office visit. The physician’s office staff can easily and effectively administer the test. With a single press of a button, the instrument begins taking breath samples, performs the breath analysis and prints the results. The whole process takes 10 minutes, start to finish.

US Medicare and most private medical insurers already offer reimbursement for the BreathID test.

“We believe that the accuracy, convenience, efficiency and economics of this technology will produce a major leap forward in the way peptic ulcer and dyspeptic patients with high risk of cancer are diagnosed and treated,” said Oridion Systems president and CEO George Yariv.

The device “brings both convenience and gold standard accuracy to our daily practice,” said Dr. David Carr-Locke, Director of Endoscopy at Brigham and Women’s Hospital and President of the American Society for Gastrointestinal Endoscopy, who also served as Principal Investigator for the BreathID® multi-center clinical trial. “It is also a very convenient and cost-effective method for both pre- and post-treatment at the doctor’s office.”

In October, Oridion announced that it had signed a strategic development and marketing agreement with the electromedical systems division of Siemens Solutions.