PATHOGEN DETECTION WITH THE FILMARRAY

Transcription

1 PATHOGEN DETECTION WITH THE FILMARRAY

2 The System Sample-to-Answer in an Hour Single sample Multiple samples The FilmArray integrates sample preparation, amplification, detection, and analysis all into one complete process that delivers results in about an hour. 2

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 3

4 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. Sample Extraction & Preparation 1 st Stage Multiplex PCR 2 nd Stage PCR Reagent Storage Chemical Circuit Board 4

5 How the FilmArray Works 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. 1 st Stage Multiplex PCR Dilute 100x 2 nd Stage Singleplex PCR The system provides all the advantages of nested-pcr without the risk of contamination 5

6 How the FilmArray Works Using endpoint melting curve data, the FilmArray software automatically generates a result for each target. Automated Results Analysis 102 individual 2 nd stage PCR wells Each well contains one reaction Melt curves generated for each well Triplicates increase confidence in result 6

7 FilmArray Panels The Panels A Syndromic Approach Respiratory Panel FDA Cleared 2011 BCID Panel FDA Cleared 2013 GI Panel FDA cleared 2014 Meningitis Panel FDA cleared 2015 Biothreat-E Ebola assay FDA EUA 2014 Lower Respiratory Panel In Development FilmArray Platform After all panels are FDA-cleared, FilmArray will have assays covering >120 of the most common pathogens that cause death and disease. 7

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/H 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 8

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/H 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 9

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/H 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 This test is not FDA-cleared and not for sale in the USA 10

11 BCID Panel FDA cleared June 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 11

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) Protozoa: Cryptosporidium Cyclospora cayetanensis Entamoeba histolytica Giardia lamblia Viruses: Adenovirus F 40/41 Astrovirus Norovirus GI/GII Rotavirus A Sapovirus Shiga-like toxin-producing E. coli (STEC) Shigella/Enteroinvasive E. coli (EIEC) Sample Type: Stool in Cary Blaire 12

13 Meningitis / Encephalitis (ME) Panel FDA cleared October 2015 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) 13

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

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 15

16 ECCMID 2016 LRTI panel 16

17 ECCMID 2016 LRTI panel 17

18