Drug intelligence / Profile preview

BreathID Hp Lab System

Development stage
Unknown
Lead developer
Meridian Bioscience
Modality
Small Molecules
Administration
Oral
01

Overview

The BreathID Hp Lab System is a non-invasive diagnostic platform developed by Meridian Bioscience for the detection of *Helicobacter pylori* (*H. pylori*) infection and the confirmation of its eradication. The system utilizes a 13C-urea breath test (UBT) methodology. During the procedure, a patient ingests a 75 mg tablet of 13C-enriched urea (provided in the IDkit Hp Two collection kit). If *H. pylori* is present in the gastric mucosa, its highly active urease enzyme metabolizes the 13C-urea into ammonia and 13C-labeled carbon dioxide (13CO2). The 13CO2 is absorbed into the bloodstream and subsequently exhaled in the breath. The BreathID Hp Lab System analyzes these breath samples using proprietary Isotope Specific Infrared (ISIR) technology to measure the ratio of 13CO2 to 12CO2. This system is specifically designed for high-volume reference laboratories and has demonstrated high sensitivity and specificity in clinical studies for both initial diagnosis and post-treatment monitoring.

Brand names
BreathID Hp Lab SystemBreathID HpIDkit Hp Two
Other names
13C-Urea Breath TestBreathID Hp System
02

Targets

Urease

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