The BreathID® System from Exalenz enables you to perform non-invasive, highly accurate urea breath tests for detecting H. pylori. Tests are ordered by the physician and performed by any trained staff member. No CLIA licensed is required. It is the most accurate (100% sensitivity, 99.2% specificity), fastest (~10 minutes from start to results), and easy to use (1-button operation) system available. It also offers enhanced revenue potential compared to every other non-invasive H. pylori test – nat
Major clinical guidelines support Urea Breath Testing (UBT) for the detection of H. pylori infection:
· For Initial Diagnosis: “The UBT … tests provide reliable means of identifying active H. pylori infection before antibiotic therapy.”1
· For Post-treatment Follow-up: “UBT is the most reliable nonendoscopic test to document eradication of H. pylori infection.”1
· As a preferred modality: “A positive [H. pylori blood antibody] test is no better than a coin toss in predicting the presence of active infection.”1
The BreathID® Breath Test System from Exalenz Bioscience offers compelling advantages for your practice:
Reimbursement is straightforward using established CPT codes (83013 & 83014).
· 10 minutes from start to results
· Enables on-the-spot testing
(patients presenting with symptoms)
· Test & treat in a single visit
· 100% Sensitivity, 99.2% Specificity2
· ~150 exhalations included in analysis
· Validated in multiple studies published in peer-reviewed journals
· Used in numerous pharmaceutical and academic clinical trials
· CLIA non-regulated (no CLIA license required)
· Any trained staff member can operate the system
· Simple, 1-button operation
· Easy for patient – patient breathes normally
With the BreathID® System in your office, you can advance your care of patients who present with GI symptoms, abdominal pain, dyspepsia and ulcers:
· Get accurate results
· Advance patient diagnosis – for initial diagnosis and confirmation of eradication
· Confidently establish treatment plans
· Streamline patient management
1. Chey W, et al. American college of gastroenterology guideline on the management of helicobacter pylori infection. Am J Gastro 2007; 102: 1808-25.
2. Data on file, Exalenz Bioscience, Ltd.
EXALENZ 60 Silver Lane | | Holliston | MA | Exalenz Bioscience develops and markets advanced systems that extract vital information for diagnostics from subtle changes in patients’ exhaled breath, enabling medical specialists to identify and manage specific digestive and liver conditions at the point-of-care.
MERETEK DIAGNOSTICS GROUP OF OTSUKA AMERICA PHARMA
Meretek Diagnostics Group of OAPI provides the BreathTek™ UBT for H. pylori test, which is cleared by FDA. BreathTek UBT is CLIA non-regulated and indicated for initial diagnosis and post-treatment monitoring of an active H. pylori infection. The test can be administered in a physician’s office in about 20 minutes.
CLIA Non-Regulated H.Pylori Test
BreathTek UBT is CLIA non-regulated and the only UBT FDA-approved for both the initial diagnosis and conformation of cure of H. pylori. The test is easily administered in the office setting, with results in about 2 minutes. Meretek Diagnostics manufactures the BreathTek™ Urea Breath Test (UBT) for H. pylori. As serology testing cannot distinguish between a current and past infection, the American Gastroenterological Association now recommends “active” tests, such as the BreathTek UBT.
MERETEK DIAGNOSTICS GROUP OF OTSUKA AMERICA PHARMA 2440 Research Blvd. | Suite C | Rockville | MD | Helicobacter pylori (H. pylori) is a serious, chronic bacterial infection. An estimated 35% of the adult US population is infected