Curetis GmbH | Max-Eyth-Str. 42 | 71088 Holzgerlingen | Germany

Tel.: +49 (0)7031 49195 10 | Email: contact@curetis.com |

Unyvero is designed to expandwith your growing needsA single test handles one patient sample,

analyzes around 100 DNA analytes and delivers reliable results within just 4-5 hours

Unyvero’s sample-to-answer platform provides rapid results for severe infectious diseases in hospitalized patientsPowerful multiplex PCR technology combined with the broadest range of microorganism and resistance targets sets the Unyvero System apart.

The Unyvero System consists of:

00585 Rev 2.0 © Curetis GmbH

Caution – Investigational Device. Limited by Federal US Law to investigational Use. Not available for Sale in the United States.

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Fast & Simple Syndromic Testing for Severe Infections - Improving Patient Outcomes

Lysator to lyse and process a variety of native samples

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

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

Unyvero L4 Lysator Unyvero C8 Cockpit Unyvero A50 Analyzer

Urinary TractInfection

DNA puri� cation

PCR set-up

Multiplex PCRwith array detection

Applications for severe infections:

Blood Culture – BCU

Hospitalized Pneumonia – HPN

Intra-Abdominal Infection – IAI

Implant & Tissue Infection – ITI

Urinary Tract Infection – UTI

Working time 30 seconds

30 minutes lysis in Lysator

Assembling Unyvero Cartridge with Sample and Master Mix Tube

B

Working time 60 seconds

Transfer patient sample to Unyvero Sample Tube

A

Working time 20 seconds

Scanning and inserting the Unyvero Cartridge in the A50

(Max. 2 cartridges simultaneously)

C

EasyWork� ow

Unyvero Urinary Tract Infection (UTI) Cartridge

Work� ow of the Unyvero SystemUnyvero

Uropathogens can be detected in 4-5 hours using the Unyvero solution

Staphylococcus aureus

Coagulase negative staphylococci

Staphylococcus saprophyticus

Streptococcus agalactiae

Enterococcus spp.

Enterococcus faecalis

Enterococcus faecium

Corynebacterium urealyticum

Enterobacteriaceae

Citrobacter freundii / koseri

Klebsiella aerogenes (E. aerogenes)

Enterobacter cloacae complex

Escherichia coli

Klebsiella oxytoca

Klebsiella pneumoniae

Klebsiella variicola

Proteus spp.

Providencia spp.

Bacteroides spp. /Prevotella spp.

Acinetobacter baumannii complex

Pseudomonas aeruginosa

Detection of prokaryotic genetic sequence

Candida spp.

Candida albicans

Candida auris

Candida glabrata

Gram-positive bacteria Enterobacteriaceae Non-fermenting

bacteria

Anaerobic bacteria

Universal Bacteria

Fungi

GeneResistance

Faster detection enables earlier optimization of therapy

Urinary tract infections (UTIs) account for a major part of clinical

workloads in microbiology laboratories.

UTIs are among the most prevalent hospital-acquired infections,

and are the second most common cause of bacteremia in

hospitalized patients.2

Mortality rates for patients with urosepsis range from 25 to 60%.3

The number of UTIs caused by antibiotic-resistant bacteria

is increasing.4

The Unyvero UTI Application simultaneously identi� es a large panel of bacteria,

fungi, and antibiotic resistance genes directly from urine samples.

UTIs are among the most common hospital-acquired infection1

Annual cost for UTIs in France is €58 million.5

1 Point prevalence survey: Acute care hospitals 2011-2012.

2 WHO. Prevention of hospital acquired infections: A practical guide. 2nd edition. 2002.

3 Paech B. et al., Risk Factors for Urosepsis in Older Adults: A Systematic Review. 2016. 2:1–7.

4 English surveillance programme for antimicrobial utilisation and resistance (ESPAUR) Report 2017.

5 François M. et al., The economic burden of urinary tract infections in women visiting general practices in France: a cross-sectional survey. BMC Health Serv Res. 2016;16(a):365.

Multiple Sample Types

24/7Results

mecA

vanAvanB

ctx-M

impkpcndmoxa-23oxa-24oxa-48vim

mcr-1

qnrBqnrS

sul1

3rd generation Cephalosporins

Glycopeptides

Fluoroquinolones

Sulfonamide

Carbapenem

Polypeptides / polymyxins

Oxacillin

Catheter-associated urinary tract infections

Complicated cystitis

Urosepsis

Pyelonephritis

Unyvero UTI can be used for diagnosis of complicated urinary tract infection and their consequences:

Results displayed in Cockpit – PDF export, LIS connection

D

4 to 5 hour analysis process