{"id":"breathid-hp-lab-system","safety":{"commonSideEffects":[]},"_chembl":{"chemblId":"CHEMBL1631333","moleculeType":"Oligonucleotide","molecularWeight":"8971.40"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"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.","oneSentence":"BreathID® Hp is a non-invasive diagnostic system that detects Helicobacter pylori infection by measuring labeled carbon dioxide in exhaled breath.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:43:12.474Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Detection of active Helicobacter pylori infection"}]},"trialDetails":[{"nctId":"NCT02905825","phase":"PHASE3","title":"Urea Breath Test (UBT) With Breath Hp System /BreathID Hp Lab System Pediatrics","status":"COMPLETED","sponsor":"Meridian Bioscience, Inc.","startDate":"2017-05-18","conditions":"Helicobacter Pylori Infection","enrollment":54},{"nctId":"NCT02528721","phase":"PHASE3","title":"Exalenz Lab Mode System Compared to Biopsy for H.Pylori Detection","status":"COMPLETED","sponsor":"Meridian Bioscience, Inc.","startDate":"2015-10","conditions":"Helicobacter Pylori Infection","enrollment":282}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":3,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"BreathID® Hp Lab System","genericName":"BreathID® Hp Lab System","companyName":"Meridian Bioscience, Inc.","companyId":"meridian-bioscience-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"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.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":true,"score":3}}