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]
History & Origins : N/A
Date EUA Issued: 04/28/2020 [3]
Sources: “[1] [2] [3] [4] [5]”
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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