PATHOGEN DETECTION WITH THE FILMARRAY · Influenza A/H1-2009 Influenza B Parainfluenza 1 Parainfluenza 2 Parainfluenza 3 Parainfluenza 4 Respiratory Syncytial Virus Bacteria Bordetella

PATHOGEN DETECTION WITH THE FILMARRAY

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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

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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


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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.


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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



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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.



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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.


Biothreat-E

Ebola assay FDA EUA

2014

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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


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Respiratory Panel 2 (RP2)

FDA Cleared 2017

Viruses Adenovirus

Coronavirus HKU1

Coronavirus NL63

Coronavirus 229E

Coronavirus OC43



Influenza A

Influenza A/H1

Influenza A/H3

Influenza A/H1-2009

Influenza B

Parainfluenza 1

Parainfluenza 2

Parainfluenza 3

Parainfluenza 4


Bacteria


Bordetella parapertussis





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Respiratory Panel 2 Plus (RP2 Plus)

CE-marked 2017

Viruses Adenovirus

Coronavirus HKU1

Coronavirus NL63

Coronavirus 229E

Coronavirus OC43

MERS-CoV (MERS coronavirus)



Influenza A

Influenza A/H1

Influenza A/H3

Influenza A/H1-2009

Influenza B

Parainfluenza 1

Parainfluenza 2

Parainfluenza 3

Parainfluenza 4


Bacteria


Bordetella parapertussis





This test is not FDA-cleared and not for sale in the USA

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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


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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


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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


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Biothreat-E assay for Ebola virus (blood/urine) FDA EUA in October 2014


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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


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ECCMID 2016 – LRTI panel


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ECCMID 2016 – LRTI panel


Documents

PATHOGEN DETECTION WITH THE FILMARRAY · Influenza A/H1-2009 Influenza B Parainfluenza 1 Parainfluenza 2 Parainfluenza 3 Parainfluenza 4 Respiratory Syncytial Virus Bacteria Bordetella