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BreathID Hp Lab System (Exalenz Bioscience)
- Development stage
- Unknown
- Lead developer
- Meridian Bioscience
- Modality
- Small Molecules, Device-based Delivery → Drug Delivery Systems
- Administration
- Oral
01
Overview
The BreathID Hp Lab System is a non-invasive diagnostic medical device and test system 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. Patients orally ingest a 75 mg 13C-urea tablet along with a citric acid solution (Citrica Powder). If H. pylori is present in the stomach, its urease enzyme metabolizes the 13C-urea into 13CO2 and ammonia. The 13CO2 is absorbed into the blood and subsequently exhaled. The BreathID Hp Lab System measures the 13CO2/12CO2 ratio in the exhaled breath using Molecular Correlation Spectroscopy (MCS) technology. It is designed for high-volume laboratory settings and is FDA-cleared for use in both adult and pediatric populations (ages 3–17).
- Brand names
- BreathID Hp Lab SystemBreathID HpIDkit Hp Two
- Other names
- 13C-Urea Breath TestBreathID
02
Targets
NHPH (Non-Helicobacter pylori Helicobacter)Urease
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