NONPROFIT, NONPARTISAN PLATFORM OF ACCURATE SCIENCE-BASED SOLUTIONS TO COVID-19

BioFire Defense, LLC

Business Name:
BioFire Defense, LLC
Business Genre:
Business Description:

A company that deliver fully integrated suite of biological agent identification products, including FilmArray® and RAZOR® EX Systems to detect the viral and bactria infection [1]

City:
Salt Lake City
State:
UT
Country:
USA
Data/Evidence of Effectiveness:
SARS-CoV-2 archived specimens the positive agreement was 98% (48/49) and negative agreement was 100%. [3]
Complimentary Products Needed to Perform Test:
BioFire® FilmArray® System [3]
Setting of Care:
Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity or moderate complexity tests. [2]
Current Status / Clinical Development Stage / Expected Milestones:
EUA approval and available for sale [2]
LOD:
160-500 [3]
Funding & Ownership :
Private, Revenue range: 10M – 50M [4]
Business Model:
Sell their multiplex diagnostic systems along with specific kits for infectious diseases. [1]
IP:
Patent for the FilmArray system [5]
History & Origins :
Specialized in molecular diagnostics using multiplex solution. Merge with BioMérieux in 2014. BioDefense is one of the company splitted from the merge and focus on delivering fully integrated suite of biological agent identification products. [1]
Date EUA Issued:
05/01/2020 [2]
Sources:
“[1] https://www.biofiredefense.com/ [2] https://www.fda.gov/media/137580/download [3] https://www.fda.gov/media/137583/download [4] https://www.crunchbase.com/organization/biofire-defense#section-overview [5] https://www.businesswire.com/news/home/20130313006338/en/BioFire-Diagnostics-Announces-Issuance-U.S.-Patent-FilmArray [6] https://www.biofiredefense.com/about-us/ [7] https://www.linkedin.com/in/kirk-ririe-b136b19a/”
Organization:
Kirk Ririe [7]
No. Tests Per Day:
175 samples / day
Time to Result:
about 45 mins [3]
Test Sample Type:
Nasopharyngeal swabs [2]
Technology Overview:
Paired with the BioFire FilmArray system. After loading the sample, all the other steps including nucleic acid extraction and PCR are done automatically. Detect spike protein and membrane protein of the CoV-2. [3]
Testing Type:
Real-time, nested multiplexed PCR using BioFire® FilmArray® System [3]
Test Category:
SEROLOGY
Test Name:
BioFire COVID-19 Test
Clinical Application & Need:
Multiplexed nucleic acid test intended for the simultaneous qualitative detection and differentiation of nucleic acids from multiple respiratory viral and bacterial organisms1 , including nucleic acid from the SARS-CoV-2 virus [2]
Age of Company:
1990

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