LRT

CLEAR DIRECTIONfor hospitalized pneumonia patients

FDA-cleared Unyvero LRT... what hospitalized pneumonia patients

have been missing.

The severe pneumonia status quo needs to change

Pneumonia is a life-threatening disease that requires rapid and appropriate therapy to avoid unnecessary costs and reduce serious complications, including mortality. Unfortunately, current standard

of care microbiology culture alone does not adequately address the problem.

Current consequences

Current limitations

Ο 50% of cases misdiagnosed1 Ο Several days to get results Ο Microbiological confirmation

not always achievable2

Ο 29% of patients overtreated3 Ο 15% of patients undertreated3 Ο Only 9% of patients

appropriately treated3

Diagnosis Treatment

Ο 50% of patients experience serious complications2

Ο Upwards of 30% mortality4

Ο Exposure to unnecessary broad-spectrum antibiotics and associated side effects due to delayed definitive diagnosis2

Ο Excess of $10B annual cost5 Ο Among top 10 most costly reasons

for US hospitalization6

Ο Increased ICU and overall hospital length of stay7 by 5.5 days or longer

Health Economic

Unyvero LRT—The change that is needed

Rapid pathogen identification is the only way to treat the right bug with the right drug.Unyvero LRT provides results that can enable targeted antibiotic therapy 1-2 days faster.

Busy physiciansget rapid,

reliable, andactionable answers

Accuratediagnosis equals

earlier, optimaltreatment

Lab sees the largestnumber of relevant

pathogens andresistance markers

Cut the time clinicians wait for definitive results

Fast Pathogen identification and resistance reported in just a matter of hours

Accurate Excellent sensitivity and specificity with no growth required for detection of organisms (including fastidious and atypical) and resistance, and results not impacted by prior antibiotic use

Actionable Rapid detection of clinically relevant targets enables earlier optimal antibiotic decision

Easy Enables testing during all microbiology laboratory shifts with an automated sample-to-answer process that derives results directly from specimen

Unyvero LRT 40+hours faster

TraditionalCulture

Identification

0 20 40

Culture Isolate

Antibiotic Susceptibility Testing (AST)

Identification and Resistance Results

Comprehensive panel - because having all the right information matters when time is critical

Only Unyvero LRT uniquely detects 29 clinically relevant targets to aid clinicians in rapidly making confident diagnoses of pneumonia and earlier targeted antibiotic treatment decisions for these critically ill patients.

The Unyvero LRT panel is comprised of 19 bacterial pathogens—including atypical bacteria—and 10 antibiotic resistance markers with the broadest carbapenemase resistance coverage.

BACTERIA RESISTANCE GENES

Acinetobacter spp.Chlamydia pneumoniaeCitrobacter freundiiEnterobacter cloacae complexEscherichia coliHaemophilus influenzaeKlebsiella oxytocaKlebsiella pneumoniaeKlebsiella variicolaLegionella pneumophila

Moraxella catarrhalisMorganella morganiiMycoplasma pneumoniaeProteus spp.Pseudomonas aeruginosaSerratia marcescensStaphylococcus aureusStenotrophomonas maltophiliaStreptococcus pneumoniae

Carbapenem

kpcndmoxa-23oxa-24

oxa-48oxa-58vim

3rd Generation Cephalosporins ctx-M

Oxacillin/Cefoxitin mecA

Penicillin tem

Fast Accurate Actionable

Clear results you can count on

Drive meaningful impact through the Unyvero System’s unique capabilities.

MICROORGANISMS DETECTION

92.5% sensitivity 97.4% specificity

ANTIBIOTIC RESISTANCE MARKERS DETECTION

93.0% sensitivity 98.8% specificity

Direct sample-to-answer results with less than 2 minutes hands-on time

Simple and clear qualitative results based on inherently quantitative algorithms

Critical information for treatment decisions within hours

Overall performance of the Unyvero LRT panel8

Antibiotic Stewardship Impact

Bacterial infections of the lower respiratory tract are associated with high mortality rates. Multiple studies have proven that Unyvero LRT correctly identified several key pathogens that were missed by culture.

In one study, retrospective chart reviews concluded that patients were not adequately treated for Acinetobacter based on culture-negative results and subsequently died.

Unyvero LRT had correctly detected Acinetobacter in all cases.9

Fast results from Unyvero LRT have the potential to improve diagnosis of the etiology of pneumonia and clinical outcomes by helping to achieve targeted antibiotic use more quickly. Optimal antibiotic coverage can lead to:

Ο Targeted therapy without delay Ο More judicious use of antibiotics

Ο Decreased rate of antimicrobial resistance Ο Reduced inappropriate treatment modalities

Remove MRSA and Pseudomonal Coverage 29%

Potential Impact on Therapy Basedon Unyvero LRT Results

Stewardship Suggestedby Unyvero LRT Results

Unknown 1%

Favors No Changein Treatment 9%

Other 7%

Favors ExpandingTreatment 15%

Favors Stewardshipand Expansion 9%

Remove All Gram Negative Coverage 29%

Negative Result 37%

Remove MRSACoverage 15%

FavorsStewardship29%

Favors Stewardship 29%

Remove Pseudomonal Coverage 20%

Unyvero LRT results have demonstrated antibiotic therapy could have been optimized in >50% of cases3

Unyvero LRT favors narrowing antibiotics over expanding antibiotics nearly two-fold (29% vs. 15%).

Health Economic Impact

Optimal care that’s also cost-effective can change patient outcomes and the associated costs—for everyone.

For reliable answers within hours and the power to start the appropriate antibiotic therapy almost immediately,

incorporate Unyvero LRT into your pneumonia protocol.

Reduction in hospital length of stay

Reduction in unnecessary treatment costs and associated side effects

Potential savings by reducing rates of antibiotic resistance and readmissions

Get the right treatment for your pneumonia patients, sooner.Let Unyvero point the way to improved clinical and economic outcomes

for both patients and healthcare systems.

Faster pathogen identification and resistance detection can make a difference:

The health economics of antimicrobial resistance (AMR)

Increasingly widespread use and misuse of antibiotics have led to the rapid rise of antibiotic resistance. Consequently, more and more infections are caused by microorganisms that fail to respond to conventional antibiotic treatments.

Given the high mortality rate of pneumonia, physicians often err on the side of caution and empirically prescribe broad-spectrum antibiotics in the absence or delay of definitive diagnostic results.

Antimicrobial (antibiotic) resistance is a substantial health economic burden

2 million people contract an antibiotic-resistant infection each year in the United States.10

$55 - $70 billion spent in total care costs, including longer hospitalization days by adding 13 days per patient and 8 million hospital days annually.11

99,000 deaths annually due to antibiotic-resistant pathogen-associated hospital-acquired infections (HAIs), with pneumonia being one of the most common HAIs.11

Ο Targeting specific therapies for the individual patient Ο Focusing on infection control prevention

Ο Advancing diagnostic and antibiotic stewardship Ο Lowering the risk of unwanted adverse events,

including the development of C. difficile.

Unyvero LRT combines comprehensive, unique bacterial targets and the broadest coverage of carbapenamese resistance markers to provide clear direction for hospitalized pneumonia.

Rapidly defining the etiology of pneumonia is imperative to2

1. Messika J, Stoclin A, Bouvard E, et al. The Challenging Diagnosis of Non-Community-Acquired Pneumonia in Non-Mechanically Ventilated Subjects: Value of Microbiological Investigation. Respir Care. 2016;61(2):225-234. doi:10.4187/respcare.04143 2. Noviello S, Huang D. The Basics and the Advancements in Diagnosis of Bacterial Lower Respiratory Tract Infections. Diagnostics. 2019;9(2):37. doi:10.3390/diagnostics9020037 3. Mopuru H, et al. Evaluation of a rapid highly multiplexed molecular diagnostic lower respiratory tract panel for clinical impact and antibiotic stewardship. Poster presented at: American Society for Microbiology Microbe; 2018 Jun 6-11; Atlanta, GA. 4. Laessig KA. End Points in Hospital‐Acquired Pneumonia and/or Ventilator‐Associated Pneumonia Clinical Trials: Food and Drug Administration Perspective. Clin Infect Dis. 2010;51(S1):S117-S119. doi:10.1086/653059 5. Centers for Disease Control and Prevention. (2015 July 14). New CDC study highlights burden of pneumonia hospitalizations among US adults [Press release]. Retrieved from https://www.cdc.gov/media/releases/2015/p0714-pneumonia-hospitalizations.html 6. American Thoracic Society. Top 20 Pneumonia Facts – 2015. Available from https://www.thoracic.org/patients/patient-resources/resources/top-pneumonia-facts.pdf. Accessed 2019 June 7. 7. Timsit J-F, Esaied W, Neuville M, Bouadma L, Mourvillier B. Update on ventilator-associated pneumonia. F1000Research. 2017;6:2061. doi:10.12688/f1000research.12222.1 8. Data on file at Curetis. 9. Pickens C, et al. Rapid diagnostic testing of bronchoalveolar lavage to detect non-fermenting gram-negative bacteria and antibiotic resistance genes. Poster presented at: American Thoracic Society; 2018 May 18-23; San Diego, CA. 10. Antibiotic /Antimicrobial Resistance | CDC. https://www.cdc.gov/drugresistance/index.html. Accessed June 7, 2019. 11. Aslam B, Wang W, Arshad MI, et al. Antibiotic resistance: a rundown of a global crisis. Infect Drug Resist. 2018;Volume 11:1645-1658. doi:10.2147/IDR.S173867

CLEAR DIRECTIONCuretis, an OpGen Group company, 708 Quince Orchard Road, Gaithersburg, MD 20878 ©2020 Curetis GmbH, All rights reserved. Unyvero is a registered trademark of Curetis GmbH. 00592 Rev. 1.0

Request an evaluation today:curetisusa.com | info_us@curetis.com | +1 619-452-3644

LRT

For hospitalized pneumonia patients Unyvero Points the Way.