Ortho Clinical Solutions

Business Name: Ortho Clinical Solutions
Business Genre:
Business Description:

In vitro diagnostics company that specializes in immunohematology [1]

City: Raritan
State: NJ
Country: USA
Data/Evidence of Effectiveness: 407 negative COVID-19 samples collected from healthy patients prior to the outbreak resulted in 100% clinical specificity. This test had a 90% Positive Percent Agreement to PCR (used to detect COVID-19 infection) for 36 out of the 40 samples collected from COVID-19 patients 15 days post-infection. Found that there was no interference by “commonly encountered” substances (biotin, hemoglobin, intrlipid, bilirubin conjugated and unconjugated) [4]
Complimentary Products Needed to Perform Test: VITROS Immunodiagnostic Products Signal Reagent,Universal Wash Reagent and Reagent Pack Storage Box (optional) with desiccant; Quality control materials such as VITROS Immunodiagnostic Products VITROS Anti‑SARS-CoV-2 IgG Controls [4]
Setting of Care: authorized laboratories in patient settings [2]
Current Status / Clinical Development Stage / Expected Milestones: NOT FDA cleared/approved; FDA approved to meet EUA criteria [2]; Note: EUA issued for “VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack used in combination with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator” [2]
Funding & Ownership : Private; Estimated revenue $500M-1B [1]
Business Model: sale ofchemistry and immunodiagnostic products (VITROS® XT 7600 Integrated System) and tranfusion medicine diagnostic products (ORTHO VISION and ORTHO VISION Max analyzers) [5]
History & Origins : The company was founded in 1979 [1] and it specializes in diagnostics, specifically serology diagnostics. It has between 1000-5000 employees [1,5]
Date EUA Issued: **same EUA letter 4/24/2020
Sources: [1]; [2]; [3]; [4]; [5] ** different instruction sheets, same EUA letter
Organization: Chris Smith (CEO), Chad Dale (COO), Heidi Casaletto (Head of Portfolio Strategy and Marketing), Chockalingam ‘Palani’ Palaniappan, Ph.D (Chief Innovation Officer) [5]
Time to Result: 48 minutes [4]
Test Sample Type: blood[2,4]
Technology Overview: chemiluminessent immunoassay for detecting IgG antibodies to SARS-CoV-2 in human serum [3-4]
Testing Type: qualitative IgG antibody test [2,4]
Test Category: SEROLOGY
Test Name: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG [2-3] **same EUA
Clinical Application & Need: detect recent or prior infection (i.e. immunity) [2]

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