BioFire Diagnostics LLC-Product Pipeline Analysis, 2017 Update

BioFire Diagnostics LLC-Product Pipeline Analysis, 2017 Update


  • Products Id :- GDME96485PD
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  • Pages: 30
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Executive Summary

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 rp, meningitis and encephalitis me, blood culture identification bcid and gastrointestinal gi 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 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

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



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Table of Contents

Table of Contents 2

List of Tables 3

List of Figures 3

BioFire Diagnostics LLC Company Overview 4

BioFire Diagnostics LLC Company Snapshot 4

BioFire Diagnostics LLC Pipeline Products and Ongoing Clinical Trials Overview 4

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

FilmArray Biothreat-E Test 11

FilmArray Biothreat-E Test Product Overview 11

FilmArray Direct Sepsis Panel 12

FilmArray Direct Sepsis Panel Product Overview 12

FilmArray Febrile Infant Panel 13

FilmArray Febrile Infant Panel Product Overview 13

FilmArray NGDS BT-E Assay 14

FilmArray NGDS BT-E Assay Product Overview 14

FilmArray Pneumonia Pathogen Panel 15

FilmArray Pneumonia Pathogen Panel Product Overview 15

FilmArray STD Panel 16

FilmArray STD Panel Product Overview 16

BioFire Diagnostics LLC-Key Competitors 17

BioFire Diagnostics LLC-Key Employees 18

BioFire Diagnostics LLC-Locations And Subsidiaries 19

Head Office 19

Recent Developments 20

BioFire Diagnostics LLC, Recent Developments 20

Jun 01, 2017: bioMerieux receives FDA Clearance for BioFire's FilmArray Respiratory Panel 2 (RP2) 20

Nov 04, 2016: Protecting our troops from disease: FDA approves early detection and diagnosis device 20

Oct 11, 2016: FilmArray Respiratory Panel EZ is CLIA waived by the FDA 21

Apr 08, 2016: FilmArray Torch is now FDA cleared with all 4 existing FilmArray Panels and the system gets CE marked 21

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 22

Jan 26, 2016: BioFire's FilmArray Meningitis/Encephalitis Panel Gets CE Marked 22

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 23

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 24

Oct 08, 2015: FDA allows marketing of the first nucleic acid-based test to detect multiple pathogens from a single sample of cerebrospinal fluid 24

Sep 24, 2015: BioFire Defense, a bioMerieux company, receives Emergency Use Assessment and Listing for FilmArray Ebola Test by the World Health Organization 25

Appendix 27

Methodology 27

About GlobalData 29

Contact Us 29

Disclaimer 29

List of Figures

BioFire Diagnostics LLC Pipeline Products by Equipment Type 5

BioFire Diagnostics LLC Pipeline Products by Development Stage 9

List of Tables

BioFire Diagnostics LLC Pipeline Products and Ongoing Clinical Trials Overview 4

BioFire Diagnostics LLC Pipeline Products by Equipment Type 5

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

FilmArray Biothreat-E Test-Product Status 11

FilmArray Biothreat-E Test-Product Description 11

FilmArray Direct Sepsis Panel-Product Status 12

FilmArray Direct Sepsis Panel-Product Description 12

FilmArray Febrile Infant Panel-Product Status 13

FilmArray Febrile Infant Panel-Product Description 13

FilmArray NGDS BT-E Assay-Product Status 14

FilmArray NGDS BT-E Assay-Product Description 14

FilmArray Pneumonia Pathogen Panel-Product Status 15

FilmArray Pneumonia Pathogen Panel-Product Description 15

FilmArray STD Panel-Product Status 16

FilmArray STD Panel-Product Description 16

BioFire Diagnostics LLC, Key Employees 18

Glossary 28

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BioFire Diagnostics LLC, Product, Pipeline, Product Pipeline, Key Pipeline, Products by Equipment Type, Equipment Type, Therapy Area, Products by Therapy Area, Development Stage, Products by Development Stage, Milestone, Products by Milestone, Major Products, Brands, No of Products, Device Class, Market, Territory, Product Name, Therapy Name, Trial Name, Trial, Indication, Summary, Event Type, Clinical Trial, MileStone, Product Status, Product Description, Description, Patent, Patent Details, Competitors, Key Employees, Subsidiaries, Locations, News, Events, Developments, medical devices, business description, company facts, trial phase, approval, estimated, technology, product patent details, phase, trial status, trial objective, trial design, trial site, business strategies, trends, pipeline and technology, sales strategies

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