Unyvero’s sample-to-answer platform provides rapid results for severe infectious diseases in hospitalized patients

Powerful multiplex PCR technology combined with the broadest range of microorganism and resistance targets sets the Unyvero System apart.

PCR set-up The Unyvero System consists of:

DNA purification Multiplex PCR Lysator to lyse and process a variety with array detection of native samples

Cockpit to manage testing process, display, store, and transmit results

Analyzer to perform DNA testing with random-access, multiplex PCR

Unyvero is designed to expand A single test handles one patient sample, with your growing needs analyzes over 100 DNA analytes and delivers reliable results within just 4-5 hours Applications for severe : Blood Culture – BCU

Hospitalized Pneumonia – HPN Implant & Tissue – ITI Intra-Abdominal Intra-Abdominal Infection – IAI – UTI Infection Leading the way to improve 00581 Rev. 1.0 © Curetis GmbH

Caution – Investigational Device. Limited by Federal US Law to investigational Use. Not available for Sale in the United States. Unyvero L4 Lysator Unyvero C8 Cockpit Unyvero A50 Analyzer patient outcomes

Curetis GmbH | Max-Eyth-Str. 42 | 71088 Holzgerlingen | Germany Tel.: +49 (0)7031 49195 10 | Email: [email protected] | www.curetis.com Intra-abdominal infections (IAI) Faster detection enables Clinical evidence demonstrates the benefits are often associated with poor earlier optimization of therapy provided by the Unyvero solution prognosis, particularly in The Unyvero IAI Application simultaneously detects a large panel of CE Performance evaluation study. high-risk patients , fungi, toxins and antibiotic resistance markers directly from Study 1 IAI samples.

Early clinical diagnosis and appropriate antimicrobial Number of samples Additional identification The Unyvero IAI Cartridge can be used for Unyvero turnaround therapy are essential in the management of intra- 332 culture positive samples. Additional potential time 4-5 hours 1 the diagnosis of: abdominal infections. Sample types were detected in 308 cases. Ascites, bile, drainage fluid, Conventional microbiology methods can take 1-4 days Acute abdomen >292 were confirmed as true pancreatic juice, peritoneal fluid, Analytical performance and diagnosis of anaerobic bacteria up to 14 days. positives (PCR and sequencing). Ascites pus, swabs, tissue; positive blood All analytes included in the Cholecystitis cultures inoculated with ascites. Delayed or inadequate antimicrobial therapy is panel achieved a sensitivity associated with poorer outcomes and increased death.2 Diverticulitis of at least 75% while 13/27 targets achieved a sensitivity Peritonitis of 100%. Surgical site infections 89.2% 99.5% IAI is the second most commonly Sensitivity Specificity Specificity ranged from 98.5% identified cause of sepsis in the to 100% over all panel targets. intensive care unit.3,4

Global antibiotic resistance continues to rise steadily and can make therapy selection difficult.5

6 Cost of antifungal treatment is very high.

Multicentre Clinical Evaluation. Barts Health NHS Trust, 1 Sartelli M et al., Management of intra-abdominal infections: recommendations by the WSES 2016 consensus conference. World J Emerg Surg. 2017; 12:22. Study 2 The Great Romagna Hub, CHU Amiens and CHU Toulouse. 2 Solomkin JS et al., Diagnosis and management of complicated intra-abdominal infection in adults and children: guidelines by the Surgical Infection Society and the Infectious Diseases Society of America. Unyvero Intra-Abdominal Infection Clin Infect Dis. 2010;50(2):133-64. 3 Lopez N et al., A Comprehensive review of abdominal infections. World J Emerg Surg. 2011; 6:7. 4 Sartelli M et al., Current concept of abdominal sepsis: WSES position paper. World J Emerg Surg. 2014; 9:22. (IAI) Cartridge 5 WHO Antibiotic Resistance Fact Sheet. November 2017. Number of samples Improved microorganism detection Time saving 6 Pagès A et al., Cost Effectiveness of Candida Polymerase Chain Reaction Detection and Empirical Antifungal Treatment among Patients with Suspected Fungal Peritonitis in the Intensive Care Unit. Value Health. 2017;20(10):1319-1328. 300 samples (mainly peritoneal Additional microorganisms identified, Using Unyvero, the average time fluids, ascites, pus and bile). in particular anaerobes, with most to results was reduced by 17h Gram-positive Anaerobic/facultative Non-fermenting Enterobacteriaceae Resistance Gene Eligibility detections (91.4%) confirmed by compared to identification results. bacteria anaerobic bacteria bacteria Samples from patients with sequencing. suspicion of intra-abdominal hours negative Escherichia coli Aeromonas spp. mecA Microbiology reported results Acinetobacter baumannii Oxacillin staphylococci complex mecC infection. 17 saved Enterobacter aerogenes Bacteroides fragilis group vanA negative for 86 samples: faecalis Pseudomonas aeruginosa Vancomycin Enterobacter cloacae Bacteroides spp./ vanB Enterococcus spp. complex Prevotella spp. Aminoglycoside aacA4 Of these, 62 samples (72%) also (39:06 ± 16:09h for microbiology 3rd generation ctx-M spp. Klebsiella pneumoniae difficile Cephalosporins negative with Unyvero IAI while vs 22:02 ± 4:12h Unyvero IAI). Klebsiella oxytoca Fosfomycin fosA3 91.2% pathogens were detected in the Polypeptides/ Using Unyvero, the average time mcr-1 Klebsiella variicola Finegoldia magna polymyxins Sensitivity remaining 24. Fungi nimA to results was reduced by 41h Proteus spp. Propionibacterium acnes Nitroimidazole nimB In 16/24 samples, pathogens compared to full AST results. qnrA Easy Multiple 24/7 Fluoroquinolone qnrB detected by Unyvero IAI were Candida spp. qnrS Workflow Sample Types Results Candida albicans Tetracycline tetA confirmed by sequencing. hours Universal Bacteria Toxin Marker kpc 41 saved Candida glabrata oxa-23 oxa-24/40 Candida tropicalis oxa-48 99.5% Toxin B tcdB oxa-58 (64:19 ± 12:10h for microbiology Detection of prokaryotic Issatchenkia orientalis vim Specificity genetic sequence (Candida krusei) imp vs. 23:44 ± 3:58h Unyvero IAI). Shiga Toxin stx1/2 ndm