Table of Contents
Table of Contents 2
List of Tables 4
List of Figures 4
BioFire Diagnostics LLC Company Overview 5
BioFire Diagnostics LLC Company Snapshot 5
BioFire Diagnostics LLC Pipeline Products and Ongoing Clinical Trials Overview 5
BioFire Diagnostics LLC – Pipeline Analysis Overview 7
BioFire Diagnostics LLC – Key Facts 7
BioFire Diagnostics LLC – Major Products and Services 8
BioFire Diagnostics LLC Pipeline Products by Development Stage 9
BioFire Diagnostics LLC Pipeline Products Overview 11
BIOFIRE FILMARRAY Pneumonia Panel 11
BIOFIRE FILMARRAY Pneumonia Panel Product Overview 11
FilmArray 2.0 – Lower Respiratory Tract Panel 12
FilmArray 2.0 – Lower Respiratory Tract Panel Product Overview 12
FilmArray Biothreat-E Test 13
FilmArray Biothreat-E Test Product Overview 13
FilmArray Direct Sepsis Panel 14
FilmArray Direct Sepsis Panel Product Overview 14
FilmArray Febrile Infant Panel 15
FilmArray Febrile Infant Panel Product Overview 15
FilmArray NGDS BT-E Assay 16
FilmArray NGDS BT-E Assay Product Overview 16
FilmArray Pneumonia Pathogen Panel 17
FilmArray Pneumonia Pathogen Panel Product Overview 17
FilmArray STD Panel 18
FilmArray STD Panel Product Overview 18
FilmArray Torch – Lower Respiratory Tract Panel 19
FilmArray Torch – Lower Respiratory Tract Panel Product Overview 19
BioFire Diagnostics LLC – Key Competitors 20
BioFire Diagnostics LLC – Key Employees 21
BioFire Diagnostics LLC – Locations And Subsidiaries 22
Head Office 22
Recent Developments 23
BioFire Diagnostics LLC, Recent Developments 23
Apr 19, 2018: bioMerieux submits for FDA Clearance of the BIOFIRE FILMARRAY Pneumonia Panel 23
Jun 01, 2017: bioMérieux receives FDA Clearance for BioFire’s FilmArray Respiratory Panel 2 (RP2) 23
Nov 04, 2016: Protecting our troops from disease: FDA approves early detection and diagnosis device 24
Oct 11, 2016: FilmArray Respiratory Panel EZ is CLIA waived by the FDA 24
Apr 08, 2016: FilmArray Torch is now FDA cleared with all 4 existing FilmArray Panels and the system gets CE marked 25
Feb 25, 2016: BioFire Receives FDA Clearance for FilmArray Torch with FilmArray Respiratory Panel and Submits Special 510(k) Applications for Use with additional FilmArray Panels 26
Jan 26, 2016: BioFire’s FilmArray Meningitis/Encephalitis Panel Gets CE Marked 26
Jan 12, 2016: BioFire Submits Special 510(k) Application to the FDA for the use of FilmArray Torch, the New High Throughput FilmArray System with FilmArray Respiratory Panel 27
Oct 09, 2015: BioFire Diagnostics receives a de novo clearance by the FDA for the FilmArray Meningitis/Encephalitis panel continuing its extremely favorable business momentum 27
Oct 08, 2015: FDA allows marketing of the first nucleic acid-based test to detect multiple pathogens from a single sample of cerebrospinal fluid 28
Appendix 30
Methodology 30
About GlobalData 33
Contact Us 33
Disclaimer 33
BioFire Diagnostics LLC Pipeline Products and Ongoing Clinical Trials Overview 5
BioFire Diagnostics LLC Pipeline Products by Equipment Type 6
BioFire Diagnostics LLC Pipeline Products by Indication 6
BioFire Diagnostics LLC, Key Facts 7
BioFire Diagnostics LLC, Major Products and Services 8
BioFire Diagnostics LLC Number of Pipeline Products by Development Stage 9
BioFire Diagnostics LLC Pipeline Products Summary by Development Stage 10
BIOFIRE FILMARRAY Pneumonia Panel - Product Status 11
BIOFIRE FILMARRAY Pneumonia Panel - Product Description 11
FilmArray 2.0 - Lower Respiratory Tract Panel - Product Status 12
FilmArray 2.0 - Lower Respiratory Tract Panel - Product Description 12
FilmArray Biothreat-E Test - Product Status 13
FilmArray Biothreat-E Test - Product Description 13
FilmArray Direct Sepsis Panel - Product Status 14
FilmArray Direct Sepsis Panel - Product Description 14
FilmArray Febrile Infant Panel - Product Status 15
FilmArray Febrile Infant Panel - Product Description 15
FilmArray NGDS BT-E Assay - Product Status 16
FilmArray NGDS BT-E Assay - Product Description 16
FilmArray Pneumonia Pathogen Panel - Product Status 17
FilmArray Pneumonia Pathogen Panel - Product Description 17
FilmArray STD Panel - Product Status 18
FilmArray STD Panel - Product Description 18
FilmArray Torch - Lower Respiratory Tract Panel - Product Status 19
FilmArray Torch - Lower Respiratory Tract Panel - Product Description 19
BioFire Diagnostics LLC, Key Employees 21
Glossary 32
List of Figures
BioFire Diagnostics LLC Pipeline Products by Equipment Type 6
BioFire Diagnostics LLC Pipeline Products by Development Stage 9