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What is BioFire® (bioMérieux) FilmArray® System?


Elimination of Guesswork with the BioFire® FilmArray® System (bioMérieux)

The BioFire System performs syndromic PCR tests that detect infectious agents at the molecular level. With a revolutionary syndromic approach and the broadest target menu on the market, the bioMérieux or BioFire® FilmArray® Panels empower healthcare providers to choose the right test, the first time.

Traditional infectious diseases diagnostic procedures leave many infections undiagnosed, which result in  downstreaming of  tests and procedures, compromised care and patient dissatisfaction.


What is the new name for Biofire?

The new name for Biofire is bioMérieux. For several years BioFire was continuing to maintain its brand identity and operations. BioFire was acquired in 2014 by bioMérieux SA, which they claim being a global leader in in vitro diagnostics for more than 55 years.

They then reached a critical point in our development where it made sense to them to align more closely with bioMérieux,” explains Andrea Kendell, CFO North America & VP Finance Global Manufacturing for bioMérieux. “What this means, is that beginning in January 2022, BioFire products will be folded into the bioMérieux product portfolio. As a company, it will simply be known as bioMérieux.”

 

 

 

  

What are BioFire® FilmArray® Panels?

Biofire or bioMérieux panels are which are Comprehensive Panels giving Better Diagnostics

The BioFire Panels test for bacteria, parasites, viruses, yeast and antimicrobial resistance genes. Whether one desires to select appropriate therapy for septic patients or determine exactly which respiratory pathogen is making a young child ill, the BioFire® FilmArray® Systems can produce answers really quick.

biofire film array


Designed with the syndromic approach, each panel can detect a broad grouping of probable pathogenic causes in a single and rapid test.

Comprehensive panels remove the scope of guess work, giving laboratories and healthcare providers a higher probability value of identifying pathogens associated with infectious diseases. Product availability varies form country to country. You need to consult your bioMérieux representative in order to procure it.

 

What is The BioFire® Respiratory 2.1?

(RP2.1) Panel

The FDA De Novo authorized BioFire RP2.1 Panel is known as a frontline test to help clinicians quickly diagnose respiratory infections taking place, including COVID-19, influenza, RSV and many more.

SARS-CoV-2 is one of the top concerns for patients and clinicians, but several respiratory pathogens can cause nearly non-distinguishable symptoms.

Biofire respiratory


 

1 Test. 22 Targets. -45 Minutes

The BioFire RP2.1 Panel uses a syndromic type approach to accurately detect and identify the pathogens in most common association with respiratory infections.

Rapid respiratory PCR test results most probably enable better-informed diagnosis and treatment of patients. 

Fast and comprehensive BioFire RP2.1 Panel offers a run time of about 45 minutes, thereby  enabling high efficiency and throughput on the BioFire® FilmArray® 2.0 and the BioFire® FilmArray® Torch Systems. 

Quick turnaround on a broad menu of pathogens may also help the clinicians make vital decisions regarding admission, isolation, cohorting and additional diagnostic testing.

 

THE BIOFIRE RESPIRATORY 2.1 PANEL MENU

Overall 97.1% sensitivity & 99.3% specificity (prospective specimens) 1

SARS-CoV-2 98.4% PPA and 98.9% NPA2

Sample Type: Nasopharyngeal swab in transport media or saline

 

Which are Diagnosable Viruses by  BioFire® FilmArray® System?

● Adenovirus

● Coronavirus 229E

● Coronavirus HKU1

● Coronavirus NL63

● Coronavirus OC43

● Human Metapneumovirus

● Human Rhinovirus/Enterovirus

● Influenza A virus

● Influenza A virus A/H1

● Influenza A virus A/H3

● Influenza A virus A/H1-2009

● Influenza B virus

● Parainfluenza virus 1

● Parainfluenza virus 2

● Parainfluenza virus 3

● Parainfluenza virus 4

● Respiratory syncytial virus

● Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

 

BioFire® FilmArray®



BACTERIA:

● Bordetella Parapertussis

● Bordetella Pertussis

● Chlamydia Pneumoniae

● Mycoplasma Pneumoniae

 

Value of the Syndromic Approach and COVID-19

In few cases, as many as 20% of COVID-19 patients have co-infections with some other respiratory viruses.

As respiratory symptoms are quiet similar and also overlap, a syndromic panel can provide fast, comprehensive answers and wedd the guesswork out of choosing for which pathogens to test.

Study results usually suggest higher rates of co-infections between SARS-CoV-2 and other respiratory pathogens than previously reported.

 

How to Improve Clinical Outcomes through Biofire?

The BioFire® FilmArray® Respiratory Panels have been proving to significantly reduce ICU days3 and duration of antibiotic use. Also, to optimize patient management with clinically actionable results.

 

Biofire Solutions For Labs

Faster Results. Improved Workflow.

The BioFire® FilmArray® System is scalable and easy to use. This enables its easy integration into clinical laboratories.

This helps to streamline lab workflow and maximize productivity with multiplex PCR testings with infectious disease diagnostics from the BioFire System solution.

 

What is Syndromic Testing with BioFire System?

The BioFire System combines speed, ease of use and a growing portfolio of comprehensive panels into one sample answer system.

BioFire offers a syndromic infectious disease testing approach that targets a broad menu of possible pathogens in single rapid test. Because of the ease of its use, BioFire System can be used around the clock, eliminating the necessity to delay or send out certain tests.

Also, BioFire’s molecular diagnostics may enable long time cost savings as comparable with traditional testing solutions available.

 

Fast

The BioFire® FilmArray® Panels have a run-time of about 1hr, allowing labs to provide answers to physicians in a time frame of clinical relevance.

 

Easy

The BioFire System takes only 2 minutes of hands-on lab technician time. This is  without precise measuring or pipetting.

The sample is automatically analyzed and results are reported in an easily readable form.

 

Comprehensive

The comprehensive BioFire Panels are also helpful in detecting co-infections as well as uncommon pathogens.

Syndromic molecular diagnostics are able to help labs in streamlining their workflow by reducing serial or send-out testing.


 

How The BioFire FilmArray System Works?

Each BioFire Panel pouch stores all the necessary reagents for sample preparation, reverse transcription-PCR, PCR and detection in a freeze-dried format. 

During a run, the BioFire System extracts and purifies all nucleic acids from the unprocessed sample. Then it performs a nested multiplex PCR. 

During the first stage, the system performs a single, large-volume, multiplexed reaction. 

Finally, individual single-plex, second-stage PCR reactions detect the products from the first-stage PCR.

Using endpoint melting curve data, the BioFire System software automatically analyzes the result for each target. 

When the run is complete, the software reports whether or not each pathogen is detected in the sample.

BioFire System test run steps:

1.            SETUP Inject hydration solution and an unprocessed sample.

2.            TEST Insert the pouch into the BioFire System unit and start the run.

3.            GET RESULT The software reports whether or not each pathogen is detected in the sample.

 

 

What is BioFire Syndromic Trends?

BioFire Syndromic Trends (Trend) is a software feature from BioFire that provides local and regional pathogen circulation trends on demand. 

Users can view pathogen trends for their lab as well as regional and national pathogen trends, all of which are created from de-identified data that has been aggregated with other participating institutions’ test data.

BioFire Trend delivers automatic weekly email reports and allows users to explore their data using BioFire Trend’s online dashboard, which enables users to further explore their data by location, laboratory, or even chart type.

 

BioFire Syndromic Trends Features

•             Downloadable custom reports

•             De-identified data to protect patient privacy

•             Weekly notifications for local and regional activity

•             Near real-time data collection and historical data access

•             Unlimited licenses to clinical website for data collection

 

How Do I Join the BioFire Syndromic Trends Network?

This feature is available to BioFire customers, and connecting takes just minutes. Get the most out of your syndromic testing by signing up to join the BioFire Syndromic Trends Network today.

 

What are Biofire Solutions for Customers?

1st in Diagnostics, 1st in Customer Care

BioFire understands that ongoing management of a diagnostics platform in the clinical laboratory or in clinic-based settings is not a trivial task. With that in mind, Biofire aims to provide easy access to information and resources to help current customers use BioFire products and services with complete confidence.

 

Does Biofire have World Class Support Team?

The BioFire Support team is comprised of several highly trained, experienced groups dedicated to client success.

 

Customer Technical Support of Biofire

With the urgent nature of patient and community care, Biofire takes pride in addressing all concerns quickly and accurately.

BioFire is dedicated in provision of  world class customer support 24 hours a day, 7 days a week, 365 days in a year.

For assistance you may contact Biofire  customer technical support team at:

•             support@biofiredx.com

•             801-736-6354 option 5

•             1-800-735-6544

 

Who are Biofire Field Application Specialists?

Biofire Field Application Specialists are specialized BioFire employees who ensure customer satisfaction during the initial installation and verification process of BioFire® FilmArray® System.

Biofire Field Application Specialist will provide appropriate training and ensure your team is ready to use BioFire System and panels.

 

Who are Biofire Medical Education Liaisons?

Biofire Medical Education Liaisons are those who work directly with your clinicians and hospital staff in optimizing the use of the BioFire System in client’s facility. This may include working with Antimicrobial Stewardship Program and Infection Control Committee as clients change their protocols and clinical pathways in response to earlier pathogen identification and clinical diagnosis by the use of our BioFire® FilmArray® Panels.

 

Biofire Frequently Asked Customer Questions - FAQs

Q. How do I place an order or check on my existing order?

Ans. You may contact Customer Service at salesorders@biofiredx.com or by phone at:

• +1-801-736-6354 x1502

• International Sales No.: +1-801-736-6354 x1502

 

Q. Where can I find Safety Data Sheets?

Ans.  All of our SDS can be found on the Documents Page under Support.

 

User Guide

Product specific manuals are listed in the Instructions for Use and Manuals section of the documentation page and will include links to the electronic labeling site for your convenience.

System maintenance is complete, latest documentation version, customers can choose to download in multiple languages.

 

CLSI Program Format Template

BioFire understands that technical procedures must be clear. We provide BioFire Panel program templates in CLSI format. Customers can download these templates and customize them for the specific needs of their labs.

 

Technical Description

Technical notes are a form of communication that BioFire uses to provide information to customers. These documents, generated by the customer's technical support team, can be an invaluable resource in the laboratory.

Technical notes can be downloaded from the documentation section of the website.

 

What is Biofire's mission and values?

BioFire simplifies the lives of our customers with innovative, easy-to-use clinical molecular diagnostic solutions that deliver reliable results.

 

BioFire®

 

What are BioFire's combination therapies that are transforming infectious disease diagnostics?

Many infections have similar signs and symptoms. However, today's targeted infectious disease diagnostics limit testing to the most common pathogens associated with clinical syndromes. As a result, most infections go undiagnosed, leading to additional downstream testing, patient dissatisfaction and disruption to patient care. BioFire's approach to infectious disease diagnostics changes all that.

The syndromic approach is a symptom-based diagnostic approach that combines a wide range of possible etiologies into one rapid test. This makes it easy for doctors to choose the right test the first time.

Biofire’s  innovative teams are leading the industry in infectious disease diagnostics, offering molecular solutions to reduce time to medical results, enable healthcare professionals to make better diagnostic decisions and reduce healthcare costs.

Biofire are committed to improving the quality of life for everyone, everywhere and every day.

 

Author's Bio



Name: Ian Skyler

Education: MBBS, MD

Occupation: Medical Doctor 

SpecializationCommunity Medicine, General Surgery, Natural Treatment

Experience: 18 Years as a Medical Practitioner

 

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