Exalenz Bioscience, a developer of advanced diagnostic systems that use a patient's breath to detect and help manage gastrointestinal and liver conditions, has announced the global launch of the BreathID Hp, a next generation device in the company's BreathID product line. BreathID Hp facilitates a 'test and treat' protocol, as recommended by the American College of Gastroenterology (ACG) guideline, by offering the most technologically advanced, fastest, highly accurate and specific, non-invasive test for H. pylori.  

According to the Centers for Disease Control, 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 (stomach) cancer.

Exalenz also announced that it has formed in the US a new direct sales and clinical support organization, designed to better address customer needs. The new strategy will provide improved support for the company's innovative, diagnostic system, intended for in-office and urgent care facility use.

"I'm very excited about the next generation product and our new US organization, which includes an existing and newly hired sales team as well as a clinical support team.  In addition, a couple of weeks ago, former J&J executive Ted Foltyn joined Exalenz as the new VP. of Worldwide Marketing and Business Development.  I'm confident that with all of these additions the company will make significant progress in addressing the global market," said Lawrence Cohen, CEO of Exalenz.

BreathID Hp is a compact system that can fit on a small table or countertop.  The new device is EMR (electronic medical records) compatible and Clinical Laboratory Improvement Act (CLIA) non-regulated – essentially, any properly trained healthcare professional can operate it by simply following the screen-displayed directions.

The BreathID Hp test is very easy to perform and takes approximately 10-15 minutes to complete and deliver results, thus enabling the physician to immediately prescribe treatment if necessary. The system can also be used to test if the H. pylori bacteria has been eradicated. BreathID Hp provides a huge benefit for the health care system by reducing costs and repeat patient visits. Testing costs are reimbursable by Medicare, Medicaid and most other payers.

"Our new strategy is to provide physicians with the best technology and complementary service to assist them in caring for their patients and help them to 'test and treat' in the most cost effective, efficient manner possible. Our new sales and clinical support teams are available to work directly with physicians in terms of system education, training, utilization and proper integration," said Foltyn.

Helicobacter pylori (H. pylori), is a Gram-negative, microaerophilic bacterium found in the stomach and linked to the development of various digestive conditions as well as peptic ulcers and gastric cancer. According to reports, approximately 20% of people under 40 years old and half of adults over 60 years old in the U.S. are infected, with higher rates in developing countries.  Usually, H. pylori is diagnosed using a stool sample or a blood test.  These tests are more invasive and don't directly detect the presence of the bacteria. For these and other reasons, leading practice associations, like the ACG, recommend breath testing as a non-invasive choice for the diagnosis, management and eradication of H. pylori.