RAPID RELIABLE RESULTS

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Presentation transcript:

RAPID RELIABLE RESULTS 2013-01-25 RAPID RELIABLE RESULTS

The gold standard for diagnosis of Helicobacter pylori RAPID RELIABLE RESULTS Based on a unique patented formulation for fast disintegration 2013-01-25

Unique tablet formulation: fast disintegration Shortest waiting time – only 10 minutes to sample Outstanding reliability with 100% Specificity and 99% Sensitivity Just swallow with a glass of water Validated for both Mass Spectrometry and IR-Analyzers (IRIS®) Longest shelf life (4 years) 1) Gatta et al: A rapid, low-dose, 13C-urea tablet for the detection of Helicobacter pylori infection before and after treatment. Aliment Pharmacol Ther 2003; 17: 793-798 2) Jachmann et al: Diabact® UBT – IRIS ®/MS Evaluation. UEGW Amsterdam – Kibion Symposium, Oct 20-24, 2012. 3) Diabact UBT SPC 2013-01-25 RAPID RELIABLE RESULTS

Tablet pack of 10 for hospitals and laboratories Can be combined with breath bags or exetainer tubes Complete Test Kit with one tablet in a blister, 2x2 tubes and a straw The box can be sent directly to the reference Laboratory 2013-01-25 RAPID RELIABLE RESULTS

The first choice of leading gastroenterologists Validated UBT test Available since 1999 More than 600.000 diagnoses No serious adverse events reported Most convenient for patients and health care providers 2013-01-25 RAPID RELIABLE RESULTS

Validated on Mass Spectrometry and NDIR platform C13 UBT Comparison Specificity Sensitivity Formulation Time to sample Validated on Mass Spectrometry and NDIR platform Diabact 100 % 99 % Tablet to be swallowed 10 min YES Helicobacter Test / INFAI 98,5 97,9 Solution 30 min BreathTek / Otsuka 89,7 95,2 15 min Heliforce / Richen Force No data avaliable 20-30 min NO Helikit / Isodiagnostika 95 98 Tau-Kit Isomed Pharma 96 94 10 + 30 min Expirobacter Sofar C13 Urea Exalenz 2013-01-25 RAPID RELIABLE RESULTS

The best UBT in the market Fast disintegration Shortest waiting time, 10 min Most attractive formulation: patented tablet Best UBT product on the market Site specific delivery Lowest Dose, 50 mg 2013-01-25 RAPID RELIABLE RESULTS

Diabact vs INFAI USER FRIENDLINESS LOWEST DOSE SHORTEST WAITING TIME Most attractive formulation LOWEST DOSE Tablet to be swallowed No juice or test meal required Diabact Powder to be dissolved in water Need for juice INFAI 50 mg. Rapid dissolve Diabact 75 mg. INFAI SHORTEST WAITING TIME HIGHEST ACCURACY 10 minutes Thanks to the rapid dissolving tablet Diabact 30 minutes INFAI 100% Specificity, 99% Sensitivity No false positives Diabact 97,9 Specificity, 98% Sensitivity INFAI 2013-01-25 RAPID RELIABLE RESULTS

Test Procedure Exhale into base line tubes (blue cap) Swallow the tablet with water Wait 10 minutes, then exhale into sample tubes (red cap) Place the tubes with the patient identity in the box and send it to the lab. 2013-01-25 RAPID RELIABLE RESULTS

Advantages No need for test-meal or mixing of solution Short time to sampling, only 10 min Site specific delivery permits use of low dose of 13C urea, 50 mg 2013-01-25 RAPID RELIABLE RESULTS

Selected publications Wong et al: A rapid-release 50-mg tablet-based 13C-urea breath test for the diagnosis of Helicobacter pylori infection. Aliment Pharmacol Ther 2003; 17:253-257 Fennerty: Helicobacter pylori: Why it still matters in 2005. Cleveland Clinic Journal of Medicine, Vol 72, Suppl 2, May 2005 Gatta et al: A rapid, low-dose, 13C-urea tablet for the detection of Helicobacter pylori infection before and after treatment. Aliment Pharmacol Ther 2003; 17: 793-798 Peter Malfertheiner et al: Management of Helicobacter pylori infection - the Maastricht IV/ Florence Consensus Report Gut 2012;61:646-664 Jachmann et al: Diabact® UBT – IRIS ®/MS Evaluation. UEGW Amsterdam – Kibion Symposium, Oct 20-24, 2012. R.H. Hunt et al. Helicobacter pylori in developing countries. WGO Global Guideline H. pylori 2010 2013-01-25 RAPID RELIABLE RESULTS

A method with unique advantages RAPID RELIABLE RESULTS Based on a unique patented formulation for fast disintegration 2013-01-25 RAPID RELIABLE RESULTS

RAPID RELIABLE RESULTS RAPID RELIABLE RESULTS 2013-01-25 RAPID RELIABLE RESULTS RAPID RELIABLE RESULTS