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

Biocerna

Business Name:
Biocerna
Business Genre:
Business Description:

CLIA-certified and CAP-accredited laboratory dedicated to delivering clinical diagnostics tests to improve patients’ safety and quality of care [2]

City:
Fulton
State:
MD
Country:
USA
Data/Evidence of Effectiveness:
Positive Percent Agreement (PPA): 30/30 = 100%, Negative Percent Agreement (NPA): 30/30 = 100% [4]
Complimentary Products Needed to Perform Test:
MagMAX Viral/Pathogen Nucleic acid isolation kit and QuantStudio 5 real-time PCR system [4]
Setting of Care:
Biocerna, certified under the Clinical Laboratory Improvement Amendments of 1988(CLIA), 42 U.S.C. §263a [4]
Current Status / Clinical Development Stage / Expected Milestones:
The procedure received the EUA and ready to perform [3]
LOD:
250-375 [4]
Funding & Ownership :
Revenue: 5 million [5]
Business Model:
They are clinical lab that help performing the diagnostic tests [2]
IP:
N/A
History & Origins :
N/A
Date EUA Issued:
04/28/2020 [3]
Sources:
“[1] http://www.biocerna.com/ [2] https://www.linkedin.com/company/biocerna/about/ [3] https://www.fda.gov/media/137451/download [4] https://www.fda.gov/media/137450/download [5] https://www.zoominfo.com/c/biocerna-llc/374918733”
Organization:
Christopher Sanders (CEO)
No. Tests Per Day:
assume prep time + run time 3 hrs for every 96 samples, ~800 / day
Time to Result:
N/A
Test Sample Type:
nasal, mid-turbinate, nasopharyngeal, and oropharyngeal swab and bronchoalveolar lavage (BAL) specimens [4]
Technology Overview:
The test is not a new kit, it uses the ThermoFisher Scientific TaqPath COVID-19 Combo Kit that was FDA authorized for emergency use (EUA) on March 13, 2020. 3 regions from SARR-CoV2 are used: the Orf1ab, N gene and S gene. [4]
Testing Type:
real-time reverse PCR for qualitative detection of nucleic acid from SARS-CoV-2 [4]
Test Category:
RT-PCR
Test Name:
SARS-CoV2-Test
Clinical Application & Need:
acute infection [3]
Age of Company:
2012

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