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BreathID® Hp Lab System
BreathID® Hp Lab System is a Small molecule drug developed by Meridian Bioscience, Inc.. It is currently in Phase 3 development for Detection of active Helicobacter pylori infection.
BreathID® Hp is a non-invasive diagnostic system that detects Helicobacter pylori infection by measuring labeled carbon dioxide in exhaled breath.
The BreathID Hp Lab System is a diagnostic tool used to detect Helicobacter Pylori infection. It is based on an oligonucleotide modality and is used in conjunction with a 13C-urea breath test.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | BreathID® Hp Lab System |
|---|---|
| Sponsor | Meridian Bioscience, Inc. |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
The system uses the urea breath test (UBT) principle: patients ingest labeled urea (either 13C or 14C), which is metabolized by H. pylori urease enzyme into ammonia and labeled CO2. The labeled CO2 is absorbed into the bloodstream and exhaled in breath, where it is measured by the device to confirm active H. pylori infection. This provides a non-invasive alternative to endoscopic or serological testing.
Approved indications
- Detection of active Helicobacter pylori infection
Common side effects
Key clinical trials
- Urea Breath Test (UBT) With Breath Hp System /BreathID Hp Lab System Pediatrics (PHASE3)
- Exalenz Lab Mode System Compared to Biopsy for H.Pylori Detection (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- BreathID® Hp Lab System CI brief — competitive landscape report
- BreathID® Hp Lab System updates RSS · CI watch RSS
- Meridian Bioscience, Inc. portfolio CI
Frequently asked questions about BreathID® Hp Lab System
What is BreathID® Hp Lab System?
How does BreathID® Hp Lab System work?
What is BreathID® Hp Lab System used for?
Who makes BreathID® Hp Lab System?
What development phase is BreathID® Hp Lab System in?
Related
- Manufacturer: Meridian Bioscience, Inc. — full pipeline
- Therapeutic area: All drugs in Gastroenterology / Infectious Disease
- Indication: Drugs for Detection of active Helicobacter pylori infection
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing