Fighting Antibiotic
Resistance Through
Innovation
June 3, 2013
Speakers





Cynthia L. Sears, MD, Infectious
Diseases Society of America and Johns
Hopkins University School of Medicine
Regina Davis Moss, PhD, MPH, MCHES,
American Public Health Association
Lance R. Peterson, MD, NorthShore
Mike Musgnug, Alere
Teresa Raich, PhD, Nanosphere
AdvaMedDx.org
2
AdvaMedDx

Founded in 2010 as a division of AdvaMed, the medical
technology manufacturers association, to represent
manufacturers of medical diagnostic tests

AdvaMedDx functions as an “association within an
association”, with over 70 member companies – from global
industry leaders to early stage test developers

Diagnostic tests provide critical insights at every stage of
medical care

The Diagnostic Innovation Testing and Knowledge
Advancement Act of 2013, HR 2085, would reform the
Medicare diagnostics payment system to reflect value of
diagnostic tests to patient care and the health care system
AdvaMedDx.org
3
AdvaMedDx.org
Fighting Antibiotic
Resistance Through
Innovation
BAD BUGS, NEED DRUGS
Why Antibiotics Deserve Congress’
Attention and Immediate Action
Infectious Diseases Society of America
Cynthia L. Sears, M.D.
Professor of Medicine & Oncology
Johns Hopkins University School of Medicine
IDSA Treasurer
Willard N. Sears
Purple Heart, WWII
Physician Perspective
The Power of Effective Antibiotics: 1943 & today
4 y.o. girl in excellent health suddenly developed facial
skin infection, high fever. The infection spread leading to
swelling that prevented swallowing or breathing.
On arrival to the hospital
After 14 days penicillin
Herrell ’43 Proc Staff Meetings Mayo Clinic 18:65-76
Physician Perspective
The Collective Power of Effective
Antibiotics
US Infection Death Rate per
100,000 population
Antibiotics caused US deaths
to decline by ~220 per
100,000 in 15 years
Sulfa
300
100
Penicillin
All other medical technologies
reduced deaths by ~20 per 100,000
over the next 45 years
Armstrong, G. L. et al. JAMA 1999;281:61-66.
Physician Perspective
The Tragedy of Ineffective Antibiotics: The Crisis is Now
Life-altering Disability
Premature Death
www.AntibioticsNow.org
Rebecca Lohsen
(17 yr)--Dead
Carlos Don
(12 yr)--Dead
Mariana Bridi da Costa
(22 yr)--Dead
Ricky Lannetti
(21 yr)--Dead
Tom Dukes
colostomy, lost 8” colon
Addie Rerecich, 11yo
Double lung transplant
Stroke, nearly blind
$6 million hospital bill
The Crisis in Antibacterial Resistance
Geographical distribution of extreme-drug
resistant Klebsiella bacteria
Nov, 2006
Nov, 2006
Current
Extreme-drug resistant Acinetobacter
Percent Extreme-drug Resistant
Acinetobacter has risen dramatically
70%
60%
50%
40%
30%
20%
10%
0%
Common Cause of Combat Wound
Infections in US Soldiers
1999 2001 2003 2005 2007 2009
Hoffman et al ’10 ICHE 31:196-7; Higgins ’10 JAC 65:233-8; Lautenbach ’09 ICHE ’09 30:1186-92; Rosenthal
’10 Am J Infect Control 38:95-104; Hidron ‘ICHE ’08 29:996-1011; Dizbay ’10 Scand J Infect Dis; Kallen ’10
ICHE 31:528-31; NY Times
Lives Devastated/Lost
Due to
Antibiotic-Resistant Bacteria
While precise numbers are unknown
(& the CDC works to update the impact of
antibiotic resistance):
One resistant bacterium (MRSA) kills more
Americans (~19,000) annually than
emphysema, HIV/AIDS, Parkinson’s
and homicide combined.
CDC reports: 2 million HAIs/90,000 deaths
Boucher HW, Bad Bugs, Noannually
Drugs, No ESKAPE
2009; 48:1-12
inCIDU.S.
Klevens RM et al, JAMA. 2007;298:1763-1771
The majority due to antibiotic-resistant
bacteria
Additional Costs/Length of Stay
Associated with
Antibiotic-Resistant Bacteria
When antibiotic resistant bacterial
infections
are compared
to antibiotic sensitive bacterial
infections:
Annual cost to the US healthcare system:
$21-34 billion dollars
RR Roberts, CID 2009:49, 1175-1184;
Additional
days: 8 million
PD Maudlin,
AAC 2010:54,hospital
109-115
additional days
Antibiotic Development
Total # New Antibacterial Agents
IDSA’s
Motivation/Perspective
(systemic drugs)
16
14
12
Our patients need new
antibiotics
to stay healthy and alive! 1980
10
8
6
4
2
0
'83-'87 '88-'92 '93-'97 '98-'02 '03-'07 '08-'12
Primary Professional Activity
IDSA Membership
10,000 strong
Majority physicians
providing clinical care,
contributing to clinical care
4%
7% 2% 5%
8%
3%
14%
54%
3%
2012
Administration
Basic
Research
Clinical
Microbiology
Clinical
Research
Hospital
Epidemiology
Patient Care
Public Hlth
Policy Initiatives
2004
BAD BUGS, NO DRUGS
2010
BAD BUGS, NEED DRUGS
The 10 x ‘20 initiative
2011
IDSA PUBLIC POLICY
CID 52 (Suppl 5):S397, 2011
recommends:
CID 52 (Suppl 5):S397, 2011
1. Adoption of Economic Incentives and Collaborative Mechanisms
to Address the Market Failure of Antibiotics
2. New Regulatory Approaches to Facilitate Antimicrobial
Development & Approval
3. Greater Coordination of Relevant Federal Agencies’ Efforts
4. Enhancement of Antimicrobial Resistance Surveillance Systems
5. Strengthening Activities to Prevent and Control
Antimicrobial Resistance
6. Significant Investments in Antimicrobial-Focused Research
7. Greater Investment in Rapid Diagnostics R&D and
Integration into Clinical Practice
8. Eliminating Non-Judicious Antibiotic Use in Animals,
Plants & Marine Environments
Key Steps Congress can take to
Address Antimicrobial Resistance
STAAR Act Strategies to Address Antimicrobial Resistance
Awaiting Introduction/Enactment
Will strengthen federal coordination, accountability, leadership as well as
support antimicrobial stewardship efforts in health care facilities
Strengthen the antimicrobial pipeline
2012: Generating Antibiotics Incentives Now (GAIN, exclusivity) Enacted.
2013??: Still needed additional economic incentives (e.g., R&D tax credits)
plus a new FDA regulatory pathway (limited population—LPAD)
Increase funding for CDC & NIH
Antimicrobial resistance surveillance, advanced detection methods,
data collection and research
Ban antibiotic use to fatten agricultural animals (cows, pigs, chickens)
The Disheartening Current Status
of the 10 x ‘20 Initiative
Our Goal: Your Goal
Protect This Global
Treasure
Prior generations gave us the
gift of antibiotics.
Today, we have a moral
obligation to ensure this
global treasure is available
for our children and future
generations.
Fighting Antibiotic
Resistance Through
Innovation
Fighting Antibiotic Resistance
Through Innovation:
Congressional Briefing
Washington, DC
June 3, 2013
Lance R. Peterson, MD
Recipient, Eisenberg Award for Local Innovation in
Patient Safety and Quality, National Quality Forum, the
Joint Commission
Director of Microbiology and ID Research
Epidemiologist, NorthShore University HealthSystem
Clinical Professor
University of Chicago, Chicago, IL USA
Ten Wonders for Infection Control
(How to Prevent Resistance and Lower Cost)
Research
Communication
and Reporting
Education
Vaccination
Hand Hygiene
Screening and
Isolation
Antibioitc
Stewardship
Environmental
Disinfection
Outbreak
Tracking
Rapid
Diagnosis
FDA Cleared Amplification Tests
for Surveillance (as of May 11, 2013)
• MRSA (N = 6)
• MRSA/MSSA (N = 3)
• VRE (N = 1)
Source: Association for Molecular Pathology Web Page
<http://www.amp.org/FDATable/FDATable.pdf>
MRSA Prevalence by Age
n=18,898
25.0
Disease risk* = 3.7%/year
Disease risk = 8.2%/year; P=0.067
Percent Positive on Admission
20.0
15.0
10.0
5.0
0.0
0-9
10-19
20-29
30-39
40-49
50-59
Age
*Risk of invasive disease if MRSA colonized; N=993
A Robicsek et al, ICHE 30:623-32, 2009
60-69
70-79
80-89
90-99
CMS Recipients
Medical and Economic Outcome
• Excess expense of MRSA infection (compared
to no infection) = $24,000
• During the 8 years of NorthShore MRSA
containment program prevented 813 infections
– Net direct benefit from medical expense reduction is
over $16 million ($2M/Year) – ½ accrues to CMS
– Number of deaths avoided = 144 (18/Year)
LR Peterson. JCM 48:683-9, 2010
LR Peterson et al. Jt Comm J Qual Patient Saf 33:732-8, 2007
RM Klevens et al. JAMA 298:1763-71, 2007
Total MRSA Healthcare Infections
10.0
9.0
70% reduction in
total MRSA disease
during hospitalization
and 30 days post-discharge
P = 0.15
8.0
Prevalence Density
(Cases/10,000 patient-days)
7.0
2 BSI in 4 hospitals
6.0
P ≤ 0.001
Total
5.0
4.0
3.0
2.0
1.0
0.0
8/03 - 7/04
9/04 - 7/05
9/05 - 7/06
8/06 - 7/07
8/07 - 7/08
8/08 - 7/09
Years
ICU surveillance Universal surveillance
A Robicsek et al. Ann Int Med 148:409-18, 2008
LR Peterson et al. Decennial Meeting on
Nosocomial Infections, Atlanta, 2010
Predictive Modeling for RiskBased Testing
• Once a population is tested and sufficient
data collected a prediction rule can be
constructed that reduces need for testing
• Derivation cohort
– 23,314 (89.9% of patients) were tested on
admission
» 520 (2.2%) were MRSA colonized
• Validation cohort
– 26,650 (94.9% of patients) were tested on
admission
» 1,065 (4.0%) were MRSA colonized
A Robicsek et al. ICHE 32:9-19, 2011
For a preventable infectious disease,
testing cost declines with time
Prospective validation, Sept-Nov 2011
What About Decolonizing Everyone?
NEJM Results
NS Results
Comments
Scope/Population
18 months/29 ICUs 38 months/5 ICUs
Similar hospital
101,600 patient days 55,350 patient days types
Outcome
No screening and
Decolonize all
Screen all and only
Isolate positives
Rate of MRSA
clinical isolates
2.1 per 1,000
patient days
0.3 per 1,000
patient days
NS data based on
342,000 patients
Rate of all cause
bacteremia
3.6 per 1,000
patient days
1.0 per 1,000
patient days
In ICU NS is >3-fold
lower
Rate of MRSA
bacteremia
0.6 per 1,000*
patient days
0.018 per 1,000
patient days
In ICU NS is >30fold lower
Cost
$40 per patient
$27-$37 per patient
NS cost range
based on test price
(includes all MDROs)
*Most reduction in Gram positive skin commensal
organisms (Coagulase-negative staphylococci)
S Huang et al. NEJM May 29, 2013
KE Peterson et al. ICHE 33:790-5, 2012
A Robicsek et al. ICHE 32:9-19, 2011
A Robicsek et al. Ann Int Med 148:409-18, 2008
LR Peterson et al. Jt Comm J Qual Patient Saf 33:732-8, 2007
Impact of Inadequate Initial Therapy on
Mortality in ESBL Infections
Sites of infection with ESBLs
120
Klebsiella spp
E. coli
100
Association between delay in initiation of adequate
initial antimicrobial therapy and mortality
P<.001 (Χ2, Trend)
Total No.
80
60
40
20
bd nd
om
in
al
S
ST
O
th
er
d
A
W
ou
lo
o
B
to
ry
ira
es
p
R
U
rin
a
ry
*
0
*Only patients with non-urinary ESBL-E/K had a
significantly elevated risk of death
Time to institution of effective antimicrobial therapy, hours
EP Hyle et al Arch Intern Med 165:1375-80, 2005
MRSA/MSSA from Blood Cultures
• S. aureus bacteremia admitted from September
2008 through December 2008 (pre-qPCR)
compared to March 2009 through June 2009 (postqPCR; GeneXpert)
• Clinical and economic outcomes of 156 patients
• Mean switch from vancomycin to cefazolin or
nafcillin for methicillin-susceptible S. aureus
bacteremia was 1.7 days shorter (P = .002)
• Mean LOS was 6.2 days shorter (P = .07) and
hospital costs were $21,387 less (P = .02)
KA Bauer et al, CID 51:1074-80, 2010
Summary – Impact of Novel Testing
• For control of critical pathogens the role of the
clinical laboratory remains essential
• Rapid technologies enable efficient detection of
critical problems
• The role of rapid diagnostics in microbiology
partnering with infection control will revolutionize
the prevention and treatment of challenging
healthcare-associated infectious diseases and
can reduce antibiotic resistance in this decade
– Partnering between innovative industries and
government will be critical to achieve the goal
Fighting Antibiotic
Resistance Through
Innovation
Alere Inc.
The role of rapid diagnostic tests in
combating antibiotic resistance
Michael Musgnug
Vice President, Respiratory & Healthcare-Associated Infections
June 3, 2013
34
Agenda
1. Who is Alere?
2. Alere’s infectious disease testing portfolio
3. The role of rapid diagnostics
 MRSA
 Pneumonia
4. TestTargetTreat campaign
Alere’s Corporate Mission
Alere empowers individuals to take greater
control of their health under the supervision of
their healthcare providers.
We enable:
»
»
»
»
»
Earlier interventions
More targeted treatment
Fewer hospitalizations
Reduced healthcare costs
Better outcomes
World-Class Diagnostics & Health
Information Solutions
World’s leading provider of near-patient diagnostic tests
that, when combined with our novel health information
solutions, enable the effective management of several
chronic conditions.
Major US sites:
•
•
•
•
•
•
•
•
Total Employees
Massachusetts
13,500
California (NorCal & SoCal)
Maine
Represented In
Georgia
100+ countries
New Jersey
Washington
Virginia
Business Units
Florida
6
Revolutionary Infectious Disease Tests
We are the world’s leading provider of near-patient diagnostics for
the most prevalent infectious diseases
Diagnostics Leader
» HIV Screening
» Influenza
» Malaria
» C. difficile
» Strep pneumo
» Legionella
» Strep A
» Dengue Fever
» RSV
Transformational Testing Platforms
The AlereTM CD4 Analyzer
provides absolute CD4 results to
initiate and help manage
antiretroviral therapy
The AlereTM Q enables molecular
HIV viral load testing at the point
of care; applications for TB and
HCV in development
The AlereTM i is a molecular
platform for acute, near-patient
testing; launch of flu application
planned for 2014
The Antibiotic Resistance Crisis
Antibiotic Resistance – a threat to mankind
Test, Target, Treat versus…
Test, Target, Treat…
Alere’s Role in Antibiotic Stewardship
How Does Alere Help Manage This Crisis?
Does the patient need antibiotics?
Flu
RSV
Strep A
Which antibiotics are most appropriate?
Strep pneumo
Legionella
Strep A
Do they have an antibiotic resistant bacteria?
MRSA
Do they have an antibiotic-associated disease?
C. difficile
MRSA:
Identifying antibiotic resistant bacteria for better outcomes
MRSA – a big antibiotic resistance problem

What is MRSA?


How big is the problem?



MRSA is methicillin-resistant Staph aureus, an antibiotic resistant version of a
common bacterium
MRSA rates have grown considerably with the overuse of antibiotics
In 2005, there were 14 million cases of MRSA in the outpatient setting
What is the economic impact?


A case of healthcare-associated MRSA costs $94,707
The cost to isolate a patient with MRSA is $1250 per day
Year
% of S. aureus strains
that are MRSA
Shorr AF. JCM 2010 48:3258-62
1974
2%
Center for Medicare and Medicaid Services website
1995
22%
Gidengil CA. 48th annual meeting of the IDSA
2004
64%
Alere’s MRSA Test
 Traditional microbiology methods take 24-48 hours to yield a result
 This simple test takes only 5 minutes
 Faster reporting of actionable results allows better patient management


Patients with MRSA can continue on vancomycin and be put in isolation
Patients without MRSA can be de-escalated and kept out of isolation
Pneumonia:
Rapid testing to support targeted therapy and improved outcomes
Pneumonia – a major driver of healthcare
costs
 4.5 million cases of pneumonia annually, resulting in 2 million
hospitalization1,2
 Pneumonia, along with influenza, is the 9th leading cause of death
in the United States3
 #3 in the top 20 hospital discharge diagnosis groups for emergency
department visits4
 Total costs associated with pneumonia in US: $17 billion/year5
1. Centers for Disease Control and Prevention. Premature Deaths, Monthly Mortality and Monthly Physician Contacts: United States. MMWR 1997; 46:556.
2. Niederman MS, McCombs JS, Unger AN, et al. The Cost of Treating Community-Acquired Pneumonia. Clin. Ther. 1998; 20:820-837.
3. CDC Website: Deaths Final Data for 2010
4. National Hospital Ambulatory Medical Care Survey: 2010 Emergency Department Summary Tables
5. File TM Jr, Marrie TJ. Burden of community-acquired pneumonia in North American adults. Postgrad Med. 2010;122(2):130-141.
Alere’s Pneumonia Test
 Standard of care diagnostic

tools are lacking
 Take too long
 Not accurate enough
The Alere test is a simple test
that gives results in 15
minutes
 A positive result allows
targeted antibiotic therapy,
which helps prevent the
growing resistance crisis
Improved outcomes associated with Alere’s
rapid pneumonia test
 The Alere test is recommended in the IDSA/ATS
Community-Acquired Pneumonia (CAP) Guidelines
 Aids in reducing the overuse of broad-spectrum
antibiotics, which leads to antibiotic resistance
 When its findings are positive, the Alere rapid test can help the
doctor optimize antimicrobial therapy with favorable clinical
outcomes
• Potentially reduces the length of stay for hospitalized
pneumonia patients with a savings of $2,300 per day
Sordé, R., et al.; Arch Intern Med. Published online September 27, 2010. doi:10.1001/archinternmed.2010.347
Kozma, C.M., et al,; J Med Econ. 2010; 13(4):719-727.
Alere’s TestTargetTreat™ Campaign
What Doesn’t Kill Them
Makes Them Stronger.
The misuse of antibiotics has created a huge
global health crisis. The Test Target Treat™
initiative from Alere empowers healthcare
professionals to make targeted treatment
decisions sooner with rapid diagnostics —
reducing inappropriate antimicrobial use and
the spread of resistance.
TestTargetTreat.com
Fighting Antibiotic
Resistance Through
Innovation
Fighting Antibiotic
Resistance Through
Innovation
Rapid Diagnostics for
Bloodstream Infections
June 3rd, 2013
CONFIDENTIAL
Opportunities to Combat BSIs
Prevention
Universal decolonization
Clean practices (cleaning, germ soap washes, etc.)
Screening
Systematic Inflammatory Response Syndrome (SIRS)
Procalcitonin (PCT)
Rapid Diagnostics
FDA-Cleared Multiplexed Molecular Diagnostics Tests
PNA-FISH
MADLI-TOF
56
CONFIDENTIAL
Why Rapid Diagnostics for BSIs
Reduced Mortality
Each hour that the administration of appropriate antimicrobial
treatment is delayed a patient’s mortality rate increases 7.6%1
Reduce Costs
Rapid identification of the bacteria and corresponding antimicrobial
resistance reduces cost of antibiotics and patient length of stay2
Improved Antimicrobial Stewardship Initiatives
Minimize patient exposure to unnecessary antibiotics
Potentially “slow down” spread of antibiotic resistant bacteria
1Kumar
2Bauer
et al. 2006. Crit Care Med, 34:1589-96.
et al. 2010. Clin Infect Dis, 51:1074-80.
57
CONFIDENTIAL
Rapid ID of Gram-Positive
Bacteria and Resistance
Reduced Mortality
Up to 53% for S. aureus infections1
Up to 47% for Enterococci and Streptococci2
Clinical/Economic Outcomes
Implementing rapid results reporting for S. aureus blood cultures can lead to
an average 6.2-day reduction in length of stay and $21,387 reduction in cost
per S. aureus-infected patient3
Rapid mecA reporting for patients with S. aureus bacteremia results in a 25.4hour reduction in the time to optimal antimicrobial therapy4
Patients with false-positive blood culture results triggered by contaminants
such as S. epidermidis have hospitalization costs $8,750 higher than true
negative blood culture patients5
1Ly
et al. 2008. Ther Clin Risk Manag, 4:637-40., 2Gamage et al. 2011. 51st ICAAC, Poster D-1302b.
et al. 2010. Clin Infect Dis, 51:1074-80, 4Carver et al. 2008. J Clin Microbiol, 46:2381-83
5Zwang and Albert 2006. J Hosp Med, 1:272-76.
3Bauer
.
58
CONFIDENTIAL
Current Laboratory Detection
Methods of BSIs
Blood Draw from Patient
After 12-14 h incubation
(24-48 h from time of draw),
bacteria grow, lab begins ID
Incubation on Blood
Culture Monitoring
System (6-18 h)
Notify ordering physician
of positive culture and
plate for ID and
susceptibility
After 2-24 h
(48 h total) ID is
reported to physician
via chart
48-72 h from time of draw,
full ID and susceptibility
reported to physician
59
Slide from Dr. Nate Ledeboer, MCW/DynaCare/Milwakee, WI
CONFIDENTIAL
Gram-Positive BSI
Rapid Diagnostic Tests
FDA Cleared Tests:
AdvanDx (PNA FISH): S. aureus/CNS, E. faecalis/OE
Nanosphere’s Gram-Positive Blood Culture Test (BC-GP)
Tests in Development
BioFire BCID
Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP)
Staphylococcus aureus
Staphylococcus epidermidis
Staphylococcus lugdunensis
Staphylococcus spp.
Genus
Streptococcus spp.
Listeria spp.
mecA
Resistance
vanA
vanB
Species
Streptococcus pneumoniae
Streptococcus anginosus Group
Streptococcus agalactiae (GBS)
Streptococcus pyogenes (GAS)
Enterococcus faecalis
Enterococcus faecium
60
CONFIDENTIAL
Verigene BC-GP Workflow
1
2
Clinical Sample
Automated test processing
Load consumables and
sample into Processor SP
3
4
Insert substrate into
Reader for analysis
Results
61
CONFIDENTIAL
BC-GP Outcome Study1: Banner Health
Study:
6-months, 307 patients with
positive blood cultures processed
67 (22%) MSSA, 49 (16%) MRSA,
and 163 (53%) CoNS
BC-GP results compared to
traditional culture identification
Results:
Once MSSA alert received by
Pharmacy Department, on average
patient switched to nafcillin or
cefazolin within 9 hours
1Koeneman BA,
Silverberg JM, Khalsa A, Fisher H, McCabe KM,
Saubolle MA, Mochon AB. Rapid Identification of MethicillinSensitive Staphylococcus aureus from Positive Blood Cultures
using the Verigene System: A System-Wide Impact on Patient
Treatment and Physician Compliance. Poster session presented
at: American Society for Microbiology: 113th General Meeting;
2013 May 18-21; Denver, CO.
62
CONFIDENTIAL
Rapid ID of Gram-Negative
Bacteria and Resistance
Treatment often complicated by antibiotic resistance
MDR strains associated with prolonged hospital stays, higher health care costs, and
increased mortality1
Resistance rates increasing among problematic gram-negative bacteria
Acinetobacter spp., Pseudomonas aeruginosa, Enterobacteriaceae
Extended Spectrum Beta-Lactamases (ESBLs)
CTX-M becoming predominant type, replacing TEM-type and SHV-type
Carbapenemases in U.S.
Klebsiella pneumoniae Carbapenemase (KPC) predominant type
Prevalence of NDM, OXA, VIM, IMP expected to grow
1Slama,
T.G. (2008). Gram-negative antibiotic resistance: there is a price to pay. Critical Care 12(Suppl 4):S4.
63
CONFIDENTIAL
2010
2011
Trend in Carbapenem-Resistant Klebsiella
Pneumoniae from 2009 - 20111
It’s not a matter of if, but rather when this wave
of carbapenem-resistant Enterobacteriaceae
reaches the U.S.
1ECDC
Surveillance Reports on Antimicrobial Resistance in Europe
Report of the Chief Medical Officer, UK, 2011
2Annual
0
Reported Cases
2009
600
Spread of Carbapenem Resistance
in GN Bacteria in Europe
Trend in CRE cases in the
United Kingdome from
2003-20112
64
CONFIDENTIAL
Gram-Negative BSI
Rapid Diagnostics Tests
FDA Cleared Tests: AdvanDx (E. coli/P. aeruginosa, GNR Traffic Light)
Tests in Development: Nanosphere Verigene BC-GN, BioFire BCID
Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN)—In Development
Acinetobacter spp.
Escherichia coli
Proteus spp.
Klebsiella pneumoniae
Genus
Citrobacter spp.
Enterobacter spp.
KPC
Species
Klebsiella oxytoca
Pseudomonas aeruginosa
Serratia marcescens
NDM
CTX-M
Resistance
VIM
IMP
OXA
65
CONFIDENTIAL
Fighting Antibiotic Resistance
Through Innovation
Rapid Diagnostics are linked to:
• Improved patient outcomes
• Reduced healthcare costs
• Decreased LOS
• Decreased pharmacy costs
• Decreased HAIs and readmissions
• Improved antimicrobial stewardship
66
Fighting Antibiotic
Resistance Through
Innovation