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BioFire Diagnostics LLC - Product Pipeline Analysis, 2018 Update

  • Published Date: 06 Sep 2018
  • Number of Pages: 33
  • Category: Company Profile
  • Country: United States of America
Summary

BioFire Diagnostics LLC (BioFire Diagnostics), formerly Idaho Technology Inc, a subsidiary of bioMerieux SA, is a molecular diagnostics company that offers molecular biology products. The company offers solutions for healthcare providers, labs and customers. It provides respiratory, meningitis and encephalitis me, blood culture identification BCID and gastrointestinal panels to detect several pathogens including viruses, bacteria, parasites, yeast and antimicrobial resistance genes. BioFire Diagnostics offers filmarray tourch to molecular infection disease diagnostics. The company also offers filmarray Torch to fully integrated, random access system for syndromic infectious disease testing. It markets its products in clinical, research and military markets 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 companys 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

Note: Some sections may be missing if data is unavailable for the company
Publisher Name : GlobalData

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: bioMrieux receives FDA Clearance for BioFires 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: BioFires 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

List Of Tables


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

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