Approximately two-thirds of the world's population and 30 percent to 40 percent of the U.S. population are infected with Helicobacter pylori bacteria. The World Health Organization classifies H. pylori as a Class-1 carcinogen. While a number of procedures to identify H. pylori infection are in existence, one company aims to streamline diagnosis and treatment with a single, simple test.
Exalenz Bioscience's flagship product is the BreathID® Hp test, a non-invasive urea in-office breath test designed to detect active H. pylori infections within minutes. Clinical studies have demonstrated the test to have greater than 99 percent sensitivity and specificity. The device is a simple, patient-friendly test measuring normal breath versus change in the patient’s breath after drinking a substrate that interacts with active H. pylori. The accuracy and speed of the test allows for diagnosis and initial treatment in a single office visit, rather than waiting for laboratory test results.
Gastroenterologists handle significant workloads. Any new technology needs to be easily assimilated into day-to-day operations, whether in an office or ambulatory surgery center setting. Paul Lee, MD, a gastroenterologist with Digestive Disease Consultants of Orange County in Irvine, Calif., has been using the test for more than a year. "Implementing the technology into our practice was incredibly smooth and easy. There is minimal training involved and the patients are incredibly satisfied knowing that we can diagnose a problem on the first patient visit" he says.
Dr. Lee and his associates believe in urea breath testing for H. pylori, testing symptomatic patients for detection and also testing positive patients post-treatment for eradication. “This is a very convenient test to administer for my staff and is very patient-friendly. Given the various pressures placed on a physician’s office and the financial burden on the patient, patient care needs to evolve to be more efficient, effective and economical. This in-office technology helps to accomplish that.”
While ease of use is a significant benefit of any new technology, the financial side of the equation is an essential consideration for any physician practice. The BreathID test offers physicians attractive reimbursement rates that over time offset the initial cost of acquisition. "There has been very little erosion in reimbursement rates over the past several years because the test has proven value for the healthcare system," says Lawrence Cohen, CEO of Exalenz. "Some payers have even stopped reimbursement for blood testing, following the lead of the American College of Gastroenterology guidelines recommending stool or urea breath testing.”
From the perspective of Dr. Lee, one of the first considerations was the potential return on investment. "We had to consider if the ROI was acceptable. It was a significant investment to acquire the technology, but in the end patient satisfaction increased, the staff became more active and we've added an additional revenue stream all of which have made the ROI completely acceptable. We have no regrets adding this technology to our daily practice," he says.
The Exalenz test may be focused on H. pylori now, but that is just the beginning. The company is currently developing a laboratory model for the BreathID test for physicians who prefer not to perform the test in-office. Additionally, the company is investigating applications for the diagnosis and management of liver diseases, such as NASH. "We view BreathID as a platform for many tests," says Mr. Cohen.