Summary BioFire Diagnostics, LLC. (BioFire Diagnostics), a subsidiary of bioMerieux S.A., is an in vitro diagnostic (IVD) company that offers molecular biology products. Its flagship product, FilmArray is an FDA-cleared and CE-marked multiplex polymerase chain reaction (PCR) system that integrates sample preparation, amplification, detection and analysis into one closed system. Its respiratory (RP), meningitis/encephalitis (ME), blood culture identification (BCID) and gastrointestinal (GI) panels can detect several pathogens including viruses, bacteria, parasites, yeast and antimicrobial resistance genes. The company also offers FilmArray Torch, a fully integrated, random access system for syndromic infectious disease testing. The company markets its products in clinical, research and military markets the world over through its parent organization. BioFire Diagnostics is headquartered in Salt Lake City, Utah, the US. This report is a source for data, analysis, and actionable intelligence on the company's portfolio of pipeline products. The report provides key information about the company, its major products and brands. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. Scope: - The report reviews detailed company profile with information on business description, key company facts, major products and services, key competitors, key employees, locations and subsidiaries and recent developments - The report analyzes all pipeline products in development for the company BioFire Diagnostics, LLC - The report provides pipeline analysis on all pipeline products of the company (by equipment type, by indication, by development stage, and by trial status) - The report covers detailed information on each pipeline product with information on pipeline territory, stage of development, device class, regulatory path, indication(s), application(s) and estimated launch date - The report provides detailed description of products in development, technical specification and functions - The report also covers ongoing clinical trials (wherever applicable) with information on trial name, trial objective, sponsor, trial design , trial status and phase, estimated start and end date. Reasons to Buy: - Develop business strategies by understanding the trends and developments driving the medical devices pipeline and technology landscape - Design and develop your product development, marketing and sales strategies by understanding the competitor portfolio - To formulate effective Research & Development strategies - Develop market-entry and market expansion strategies - Exploit in-licensing and out-licensing opportunities by identifying products, most likely to ensure a robust return - Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline - Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage - Develop competition strategies by identifying the status and likely launch of the competitors' pipeline products through review of the clinical trials, stage and of development, etc - Identify, understand and capitalize the next high-value products that your competitor would add in its portfolio
Table of Contents
Table of Contents 2 List of Tables 4 List of Figures 5 BioFire Diagnostics, LLC Company Snapshot 6 BioFire Diagnostics, LLC Company Overview 6 BioFire Diagnostics, LLC Pipeline Products and Clinical Trials Overview 7 BioFire Diagnostics, LLC - Pipeline Analysis Overview 9 Key Facts 9 BioFire Diagnostics, LLC - Major Products and Services 10 BioFire Diagnostics, LLC Pipeline Products by Development Stage 11 BioFire Diagnostics, LLC Clinical Trials by Trial Status 13 BioFire Diagnostics, LLC Pipeline Products Overview 14 FilmArray Biothreat-E Test 14 FilmArray Biothreat-E Test Product Overview 14 FilmArray Direct Sepsis Panel 15 FilmArray Direct Sepsis Panel Product Overview 15 FilmArray Febrile Infant Panel 16 FilmArray Febrile Infant Panel Product Overview 16 FilmArray Febrile Infant Panel Clinical Trial 17 FilmArray Meningitis Panel 18 FilmArray Meningitis Panel Product Overview 18 FilmArray NGDS BT-E Assay 19 FilmArray NGDS BT-E Assay Product Overview 19 FilmArray NGDS Warrior Panel 20 FilmArray NGDS Warrior Panel Product Overview 20 FilmArray NGDS Warrior Panel Clinical Trial 21 FilmArray Pneumonia Pathogen Panel 22 FilmArray Pneumonia Pathogen Panel Product Overview 22 FilmArray STD Panel 23 FilmArray STD Panel Product Overview 23 FilmArray Torch 24 FilmArray Torch Product Overview 24 BioFire Diagnostics, LLC - Key Competitors 25 BioFire Diagnostics, LLC - Key Employees 26 BioFire Diagnostics, LLC - Locations And Subsidiaries 27 Head Office 27 Recent Developments 28 BioFire Diagnostics, LLC, Recent Developments 28 Apr 08, 2016: FilmArray Torch is now FDA cleared with all 4 existing FilmArray Panels and the system gets CE marked 28 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 28 Jan 26, 2016: BioFire's FilmArray Meningitis/Encephalitis Panel Gets CE Marked 29 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 29 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 30 Oct 08, 2015: FDA allows marketing of the first nucleic acid-based test to detect multiple pathogens from a single sample of cerebrospinal fluid 31 Sep 24, 2015: BioFire Defense, a bioMerieux company, receives Emergency Use Assessment and Listing for FilmArray Ebola Test by the World Health Organization 32 Apr 14, 2015: BioFire Submits De Novo Application to FDA for FilmArray Meningitis/Encephalitis Panel 32 Feb 26, 2015: BioFire Receives FDA Clearance for the FilmArray 2.0 System 33 Feb 10, 2015: BioFire Defense, a bioMerieux Company, Receives Prestigious Frost & Sullivan's 2014 Global New Product Innovation Award for its FilmArray Ebola Test 33 Appendix 35 Methodology 35 About GlobalData 35 Contact Us 35 Disclaimer 35
List of Tables
BioFire Diagnostics, LLC Pipeline Products and Clinical Trials Overview 7 BioFire Diagnostics, LLC Pipeline Products by Equipment Type 7 BioFire Diagnostics, LLC Pipeline Products by Indication 8 BioFire Diagnostics, LLC Clinical Trials by Trial Status 8 BioFire Diagnostics, LLC, Key Facts 9 BioFire Diagnostics, LLC, Major Products and Services 10 BioFire Diagnostics, LLC Number of Pipeline Products by Development Stage 11 BioFire Diagnostics, LLC Pipeline Products Summary by Development Stage 12 BioFire Diagnostics, LLC Clinical Trials by Trial Status 13 BioFire Diagnostics, LLC Clinical Trials Summary 13 FilmArray Biothreat-E Test - Product Status 14 FilmArray Biothreat-E Test - Product Description 14 FilmArray Direct Sepsis Panel - Product Status 15 FilmArray Direct Sepsis Panel - Product Description 15 FilmArray Febrile Infant Panel - Product Status 16 FilmArray Febrile Infant Panel - Product Description 16 FilmArray Febrile Infant Panel - Pilot Evaluation of the FilmArray Febrile Infant (FI) Panel 17 FilmArray Meningitis Panel - Product Status 18 FilmArray Meningitis Panel - Product Description 18 FilmArray NGDS BT-E Assay - Product Status 19 FilmArray NGDS BT-E Assay - Product Description 19 FilmArray NGDS Warrior Panel - Product Status 20 FilmArray NGDS Warrior Panel - Product Description 20 FilmArray NGDS Warrior Panel - Prospective Clinical Evaluation of the FilmArray NGDS Warrior Panel 21 FilmArray Pneumonia Pathogen Panel - Product Status 22 FilmArray Pneumonia Pathogen Panel - Product Description 22 FilmArray STD Panel - Product Status 23 FilmArray STD Panel - Product Description 23 FilmArray Torch - Product Status 24 FilmArray Torch - Product Description 24 BioFire Diagnostics, LLC, Key Employees 26
List of Figures
BioFire Diagnostics, LLC Pipeline Products by Equipment Type 8 BioFire Diagnostics, LLC Pipeline Products by Development Stage 11 BioFire Diagnostics, LLC Clinical Trials by Trial Status 13
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