- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
New Breath Test Detects H. pylori Bacteria
Global launch announced (July 15)
BreathID Hp, a noninvasive test for Heliocbacter pylori, has been launched globally for use in clinical practices and urgent care facilities. The device facilitates the “test and treat” protocol recommended by the American College of Gastroenterology (ACG).
According to the Centers for Disease Control and Prevention (CDC), approximately two-thirds of the world’s population is infected with H. pylori, which is often undiagnosed and untreated. It is the leading cause of peptic ulcers and is known to increase the risk of gastric cancer.
The BreathID Hp device can fit on a small table or countertop and is EMR (electronic medical records) compatible. According to the manufacturer (Exalenz Bioscience), any properly trained health care professional can operate the device by following the screen-displayed directions.
The test takes approximately 10 to 15 minutes to complete and to deliver results, thereby allowing the physician to immediately prescribe treatment if necessary. The system can also be used to test whether H. pylori bacteria have been eradicated. Testing costs are reimbursable by Medicare, Medicaid, and most other payers.H. pylori — a Gram-negative, microaerophilic bacterium — is found in the stomach and has been linked to the development of various digestive disorders as well as to peptic ulcers and gastric cancer. Approximately 20% of people under 40 years of age and half of adults over 60 years old in the U.S. are infected, with higher rates in developing countries. Usually, H. pylori infection is diagnosed using a stool sample or a blood test.
Source: Exalenz Bioscience; July 15, 2013.