BioFire Diagnostics, LLC - Product Pipeline Analysis, 2016 Update

Report code: GDME96485PD

Publisher: GlobalData

Formats: PDF

Published: June 29, 2016

Number of pages: 35

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.

Reason 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

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 bioMérieux 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 bioMérieux 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

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

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

Save time and money with a subscription

Require regular access to company intelligence? Why not consider a cost-effective subscription platform and gain access to 250,000+ reports?

To find out more, click here or call +91 (0)40 4961 4567.

Single User License
Electronic PDF copy delivered via email.

Report can be used by individual purchaser only.

$750

Site License
Electronic PDF copy delivered via email.

Report can be shared by unlimited users within one corporate location,
e.g. a regional office.

$1500

Global License
Electronic PDF copy delivered via email.

Report can be shared globally by unlimited users within the purchasing corporation
e.g. all employees of a single company.

$2250

TOP