C.difficile? 4 targets. OneStep - One Test. Genspeed. C.diff OneStep. OneStep ahead - The new molecular way of detecting C.

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1 C.difficile? OneStep - One Test 4 targets C.diff OneStep Genspeed C.diff OneStep OneStep ahead - The new molecular way of detecting C.difficile

2 The Genspeed C.diff OneStep test combines the detection of GDH, toxin A and B as well as the binary toxin in a single simple molecular diagnostic test. Clostridium difficile Clostridium difficile is an anaerobic gram positive, rodshaped, spore-building bacterium. C.difficile infection (CDI) is the most common healthcare-associated infection, causing antibiotic-associated diarrhoea (AAD) that may lead to pseudomembranous colitis and even death. CDI has an enormous impact on healthcare systems worldwide and it is estimated that C.difficile-associated diseases cause additional costs of up to EUR 3 billion per year in Europe 1. It is believed that CDI causes deaths per year in the United States of America alone 2. C.difficile spores are particularly resistant to heat, drought and disinfectants. Any C.difficile carrier can shed these spores and thus contribute to the spread of the infection. C.difficile strains show varying pathogenicity through different levels or combinations of: Toxin A (enterotoxin, also described as TcdA) Toxin B (cytotoxin, also described as TcdB) Binary toxin (also described as CdtA/B; considered to be a virulence factor, associated with recurrent CDI However the detection of these pathogenic C.difficile strains is hampered by the fact that there are toxin and non-toxin producing C.difficile strains, both of which are producing a glutamate dehydrogenase (GDH). Genspeed C.diff OneStep Test System One test - 4 targets: GDH, Toxin A/B and binary toxin The Genspeed C.diff OneStep Test System integrates the two-step method into a single assay and offers fast, sensitive and conclusive results for four relevant C.diff parameter in under 100 minutes*. Sequential two-step methods are using different combinations of different test principles: The new Genspeed C.diff OneStep Test System is a rapid in-vitro diagnostic test for the qualitative detection of toxigenic Clostidium difficile in stool samples using the Genspeed R2 Analyzer. Sampling GDH Analysis GDH ELISA (incl. GDH / Toxin A/B test) 2 nd Sampling Confirmatory toxin / Toxin testing (toxin A and/or B, binary toxin) Different Real-Time PCR and/or Antigen assays The new Genspeed C.diff OneStep test combines ease of use, generation of comprehensive high quality results with a fast time to result featuring: OneStep diagnostic algorithm One single multiplexed test for GDH, toxin A/B and binary toxin High specificity and sensitivity Fast turnaround time 4 results in under 100 min* Detection of predictive marker for recurring C.diff colitis 3 Attractive cost-benefit ratio including the Genspeed R2 Analyzer platform The Genspeed C.diff OneStep Alternative offers fast, specific and conclusive results due to its unique multi-parameter based identification algorithm: Sampling GENSPEED Genspeed C.diff OneStep Test (GDH + Toxin A/ B and binary toxin genes) One-Step assay One assay principle Better Lab-to-Lab comparability of test results *Time can vary with validated PCR-cycler used. 2 3

3 Advantages of the Genspeed C.diff OneStep Test System: Simple preanalytics, ready-to-use reagents and sensitive, multiplex PCR for fast and accurate results. A ready-to-use system with a short time to result. Single assay analysis no need for a two-step method High specificity and sensitivity, easy comparison of test results possible (lab-to-lab) Detection of GDH and C.difficile toxin genes Complete information with a single test principle Fast turnaround time Four different C.diff parameter, one test in under 100 minutes* Detection of the binary toxin Key factor in predicting the recurrence of C.difficile colitis 3 Differential diagnostics Binary toxin can be indicative for the potential virulence of the C.diff strain Simple pre-analytics No DNA extraction Cost efficiency Attractive cost-benefit ratio including the Genspeed R2 Analyzer Fast and accurate results Saving time, money and allowing fast decisions PPV of 100% No false positives** Simple pre-analytics included in the Test Kit is combined with ready-to-use reagents for fast and accurate test results. The amplified test samples are transferred to the Genspeed C.diff OneStep Test Chip and are automatically read within 10 minutes. Study-data 4 PPV 100 % ** NPV 98,9 % Specificity 100 % Sensitivity 83,3 % Prevalence 6 % Technical advantages of the Genspeed R2 Analyzer Easy handling Objective results Optional interfacing with your LIMS* Up to four devices can be used in parallel Electronic evaluation of measurement data guarantees objective results. The test system can be individually connected to your LIMS* if needed. * laboratory information management system 4 5

4 Components of the Genspeed C.diff OneStep Test System The Genspeed C.diff OneStep Test Chip facilitates rapid testing by special microfluidics for accelerated hybridization contains DNA probes for Toxin A Toxin B GDH Binary Toxin Three on-chip process controls Hybridisation control PCR control Negative control The Genspeed R2 Analyzer In order to offer optimal ease of use, the analyzer features: power supply and control via USB integrated microliter dispensing unit for automated injection of reagents from an exchangeable cartridge (48 tests) an integrated calibrator an integrated barcode module for identifying the Test Chip patented optoelectronics for highly sensitive detection The workflow: Four diagnostic parameter for C.difficile in under 100 minutes.* 1 Pre-analytical sample preparation g g < 2 minutes 2 PCR Ready-to use mastermix Fast cycling program 3 On chip assay Ready-to-use reagents Interface-guided process 4 Results Software-generated report The Notebook with integrated Genspeed Report Software controls the Genspeed R2 (up to 4 units in parallel) offers intuitive user guidance through test procedure analyses measurement data creates individualised reports allows optional connection to the LIMS Article Overview: Genspeed C.diff OneStep Test System Item N Description Packaging Genspeed Starter Package (Genspeed R2, PCR-Cycler, Notebook, Accessories) 1 piece Genspeed R2 Analyzer 1 piece Genspeed C.diff OneStep Test-Kit (incl. Preanalytics Kit) 48 tests Genspeed C.diff OneStep Test-Kit (incl. Preanalytics Kit) 16 tests The PCR-Cycler symbolic photo Accessories 2 fixed volume pipettes 1 tube rack 2 boxes GBO filter tips References 1 KuijperEJ, Cognard B, Tüll P et al. Emergence of Clostridium difficile- associated disease in North America and Europe., Clin Microbiol Infect 2006; 12 Suppl 6: ANTIBIOTIC RESISTANCE THREATS in the United States, 2013, 3 Stewart, David B.; Berg, Arthur; Hegarty, John (2013): Predicting recurrence of C.difficile colitis using bacterial virulence factors: binary toxin is the key. In: J Gastrointest Surg 17 (1), S ; discussion 124-5, Predicting recurrence of C.difficile colitis using bacterial virulence factors: binary toxin is the key. 4 Data of clinical studies 6 7

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