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

Opti Medical Systems

Business Name:
Opti Medical Systems
Business Genre:
Business Description:

Diagnostic company specializing in “manufacturing and marketing portable analyzers for the measurement of time sensitive diagnostics tests” [1]

City:
Georgia
State:
AL
Country:
USA
Data/Evidence of Effectiveness:
“Sputum: PPA = 100%, NPA = 100% ; NP Swab: PPA = 100%, NPA = 100%; LoD was confirmed to be 0.7 copies/µL in sputum (20/20) and 0.9 copies/ µL in NP swab samples (19/20) with both extraction methods [3]”
Complimentary Products Needed to Perform Test:
“Thermo Scientific Applied Biosystems® 7500 FAST Applied Biosystems® QuantStudio 5 or Agilent Mx3005P™ or Bio Molecular Systems Mic qPCR or Roche LightCycler® 480, Magnetic Bead Kit, Thermo Scientific™ KingFisher™ Flex [3]”
Setting of Care:
CLIA certified laboratories [2]
Current Status / Clinical Development Stage / Expected Milestones:
FDA-EUA approved [4] ; CE-marked [6]
Funding & Ownership :
Private [1] ; subsidiary of IDEXX Laboratories [5]
Business Model:
Opti Medical Systems offers OPTI CCA-TS2 Analyzer (a blood gas analyzer), OPTI LION Electrolyte Analyzer (electrolyte analyzer), ComfortSampler Collection Kit (sample collection)
IP:
N/A
History & Origins :
The company was founded in 1967 and offers products to analyze blood gas, electrolyte and metabolyte analysis. It’s products are distrubuted through medical distributor partners [1]
Date EUA Issued:
5/6/2020 [2]
Sources:
[1] https://www.crunchbase.com/organization/opti-medical-systems; [2] https://www.fda.gov/media/137737/download; [3] https://www.fda.gov/media/137739/download; [4] https://www.optimedical.com/products-services/C19-test.html; [5] https://www.optimedical.com/corporate-information/opti-management-team.html; [6] https://www.idexx.com/en/about-idexx/news/opti-medical-systems-ce-mark-cov-2-rna-pcr-test-kit-detection-virus-covid-19/?_ga=2.19395000.1234535317.1591454776-984539309.1591454776
Organization:
P.F. Olivier te Boekhorst (Corporate Vice President), Bryan Briggs (General Manager), Theron Gober (Director, Regulatory Affairs, Quality Assurance, and Quality Control)
Time to Result:
2-3.5 hours including RNA extraction [4]
Test Sample Type:
“nasal, nasopharyngeal, oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate [2]”
Technology Overview:
“””Real-time fluorescent reverse transcription polymerase chain reaction test for the qualitative detection of nucleic acid from the SARS-CoV-2″” [2]”
Testing Type:
qualitative in vitro detection of nucleic acid from SARS-CoV-2 [2]
Test Category:
RT-PCR
Test Name:
OPTI SARS-CoV-2 RT PCR Test
Clinical Application & Need:
acute infection [2]

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