Upload
others
View
3
Download
0
Embed Size (px)
Citation preview
PATHOGEN DETECTION WITH THE FILMARRAY
2
The System Sample-to-Answer in an Hour
The FilmArray integrates sample preparation, amplification, detection, and analysis all into one complete process that delivers results in about an hour.
Confidential Information – bioMérieux property
Single sample
Multiple samples
3
The FilmArray System
FDA cleared system – moderate complexity
Designed for hospital labs
Minimal user training
2 minutes hand-on set up time per test
Rapidly growing platform with U.S. clinical install
base >1700
Confidential Information – bioMérieux property
4
Reagent
Storage
Chemical
Circuit
Board
Sample
Extraction
&
Preparation
1st Stage
Multiplex
PCR 2nd Stage
PCR
How the FilmArray Works
The FilmArray pouch stores all the necessary reagents for sample preparation, reverse transcription-PCR, PCR, and detection in a freeze-dried format. Just inject hydration solution and an unprocessed sample. The FilmArray takes care of the rest.
Confidential Information – bioMérieux property
5
1st Stage
Multiplex
PCR
Dilute 100x
2nd Stage
Singleplex PCR
FilmArray performs nested multiplex PCR. During the first stage, the system performs a single, large volume, multiplexed reaction. Next, individual, singleplex second-stage PCR reactions detect the products from the first-stage PCR. The system provides all the advantages of nested-PCR without the risk of contamination
How the FilmArray Works
Confidential Information – bioMérieux property
6
Automated Results Analysis
102 individual 2nd stage PCR wells
Each well contains one reaction
Melt curves generated for each well
Triplicates increase confidence in result
Using endpoint melting curve data, the FilmArray software automatically generates a result for each target.
How the FilmArray Works
Confidential Information – bioMérieux property
7
The Panels
A Syndromic Approach
GI Panel FDA cleared
2014
Lower
Respiratory
Panel In Development Meningitis
Panel FDA cleared
2015
BCID Panel FDA Cleared
2013
Respiratory
Panel FDA Cleared
2011
Film
Arr
ay P
an
els
FilmArray Platform
After all panels are FDA-cleared, FilmArray will have assays covering >120 of the most common pathogens that cause death and disease.
Confidential Information – bioMérieux property
Biothreat-E
Ebola assay FDA EUA
2014
8
Respiratory Panel (RP)
FDA Cleared May 2011
Viruses Adenovirus
Coronavirus HKU1
Coronavirus NL63
Coronavirus 229E
Coronavirus OC43
Human Metapneumovirus
Human Rhinovirus/Enterovirus
Influenza A
Influenza A/H1
Influenza A/H3
Influenza A/H1-2009
Influenza B
Parainfluenza 1
Parainfluenza 2
Parainfluenza 3
Parainfluenza 4
Respiratory Syncytial Virus
Bacteria
Bordetella pertussis
Chlamydophila pneumoniae
Mycoplasma pneumoniae
Sample Type: Nasal Swab in Transport Media
First FDA-Cleared tests on the market
Confidential Information – bioMérieux property
9
Respiratory Panel 2 (RP2)
FDA Cleared 2017
Viruses Adenovirus
Coronavirus HKU1
Coronavirus NL63
Coronavirus 229E
Coronavirus OC43
Human Metapneumovirus
Human Rhinovirus/Enterovirus
Influenza A
Influenza A/H1
Influenza A/H3
Influenza A/H1-2009
Influenza B
Parainfluenza 1
Parainfluenza 2
Parainfluenza 3
Parainfluenza 4
Respiratory Syncytial Virus
Bacteria
Bordetella pertussis
Bordetella parapertussis
Chlamydophila pneumoniae
Mycoplasma pneumoniae
Sample Type: Nasal Swab in Transport Media
Confidential Information – bioMérieux property
10
Respiratory Panel 2 Plus (RP2 Plus)
CE-marked 2017
Viruses Adenovirus
Coronavirus HKU1
Coronavirus NL63
Coronavirus 229E
Coronavirus OC43
MERS-CoV (MERS coronavirus)
Human Metapneumovirus
Human Rhinovirus/Enterovirus
Influenza A
Influenza A/H1
Influenza A/H3
Influenza A/H1-2009
Influenza B
Parainfluenza 1
Parainfluenza 2
Parainfluenza 3
Parainfluenza 4
Respiratory Syncytial Virus
Bacteria
Bordetella pertussis
Bordetella parapertussis
Chlamydophila pneumoniae
Mycoplasma pneumoniae
Sample Type: Nasal Swab in Transport Media
Confidential Information – bioMérieux property
This test is not FDA-cleared and not for sale in the USA
11
BCID Panel
FDA cleared June 201313
Gram + Bacteria:
Enterococcus
L. monocytogenes
Staphylococcus
S. aureus
Streptococcus
S. agalactiae
S. pyogenes
S. pneumoniae
Antibiotic
Resistance:
mecA
Van A/B
KPC
Gram - Bacteria:
A. baumannii
H. influenzae
N. meningitidis
P. aeruginosa
Enterobacteriaceae
Enterobacter
cloacae complex
E. coli
K. oxytoca
K. pneumoniae
Proteus
S. marcescens
Yeast:
C. albicans
C. glabrata
C. krusei
C. parapsilosis
C. tropicalis
Sample Type: Positive Blood Culture
Confidential Information – bioMérieux property
12
GI Panel – FDA Cleared May 2014
Bacteria:
Aeromonas
Campylobacter
Clostridium difficile (Toxin A/B)
Plesiomonas shigelloides
Salmonella
Vibrio
Vibrio cholerae
Yersinia enterocolitica
Diarrheagenic E. coli / Shigella
E. coli O157
Enteroaggregative E. coli (EAEC)
Enteropathogenic E. coli (EPEC)
Enterotoxigenic E. coli (ETEC)
Shiga-like toxin-producing E. coli (STEC) Shigella/Enteroinvasive E.
coli (EIEC)
Protozoa:
Cryptosporidium
Cyclospora cayetanensis
Entamoeba histolytica
Giardia lamblia
Viruses:
Adenovirus F 40/41
Astrovirus
Norovirus GI/GII
Rotavirus A
Sapovirus
Sample Type: Stool in Cary Blaire
Confidential Information – bioMérieux property
13
Bacteria
S. pneumoniae
N. meningitidis
S. agalactiae
H. influenzae
L. Monocytogenes
E. coli
Virus
Enterovirus
HSV-1/2
HHV-6
CMV
VZV
Parechovirus
Fungus
Cryptococcus neoformans
/ gattii
• 15 Pathogens
• >95% of Community Acquired Causative
Agents
• Sample Type: 200 µl Cerebrospinal Fluid
(CSF)
Meningitis / Encephalitis (ME) Panel FDA cleared October 2015
Confidential Information – bioMérieux property
14
Biothreat-E assay for Ebola virus (blood/urine) FDA EUA in October 2014
Confidential Information – bioMérieux property
15
Lower Respiratory Tract Infection (LRTI) Panel
Detects most prevalent bacterial, viral and fungal pathogens implicated in pneumonia
includes detection of a suite of antibiotic resistance markers
potentially harbored by some bacterial pathogens
Accepts two classes of LRTI sample types BAL-Like (Bronchoalveolar lavage and wash)
Sputum-like (Sputum and endotracheal aspirate)
Analytes 18 bacteria, 9 viruses, 3 fungi, 7 resistance markers
37 analyte assays (largest FA panel to date)
Provides semi-quantitative results
Confidential Information – bioMérieux property
16
ECCMID 2016 – LRTI panel
Confidential Information – bioMérieux property
17
ECCMID 2016 – LRTI panel
Confidential Information – bioMérieux property