DiaSorin Inc.

Business Name: DiaSorin Inc.
Business Genre:
Business Description:

DiaSorin is an Italian multinational Group and a global leader in the market for in vitro diagnostics. DiaSorin is a global leader in the biotechnology field, supporting laboratory needs by developing, producing and commercializing reagent kits for clinical diagnostics [4].

State: Saluggia
Country: Italy
Data/Evidence of Effectiveness: “High sensitivity (97.4%) and specificity (98.5%) to assure accurate results Detection of Neutralizing antibodies: 94.4% positive agreement to Plaque Reduction Neutralization Test (PRNT) [6].”
Complimentary Products Needed to Perform Test: The test has to be performed on the LIAISON® XL Analyzer only [8]. Should also order the control kit [8].
Setting of Care: Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, to perform moderate and high complexity tests [8].
Current Status / Clinical Development Stage / Expected Milestones: FDA EUA authorized for US market [5]
Funding & Ownership : Public Annual Revenue – $763.6M [9]
Business Model: They provide immunodiagnostic and molecular diagnostic solutions world wide [1-4].
IP: The test can only be run on the registered LIAISON platform [8].
History & Origins : The company was founded in 1968 to develop in vitro diagnsotics for the European market [2]. Since then, they have expanded through acquisitions and collaborations, catering to the global diagnostic market [2]. They have 2 main specialties- immunodiagnostics and molecular diagnostics [2, 3].
Date EUA Issued: 4/24/2020 [5]
Sources: 1. 2. 3. 4. 5. 6. 7. 8. 9. 9.
Organization: Bill Carman (CEO)
No. Tests Per Day: 170 tests/ hour [6] So for 24 hours, 170 x 24 = 4080 tests.
Time to Result: Time to first result- 35 minutes [6]
Test Sample Type: Serum, plasma [8]
Technology Overview: Chemiluminescent immunoassay (CLIA) intended for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum, and plasma[8]. Test uses magnetic beads coated with the viral antigen [6]. Kit generates up to 170 results/hour on LIAISON® XL. Detection of Neutralizing antibodies: 94.4% positive agreement to Plaque Reduction Neutralization Test [6]. The antigens used in the tests are expressed in human cells to achieve proper folding, oligomer formation, and glycosylation, providing material similar to the native spikes. This strategy ensures that the antigen-antibody complex forms with the required specificity [6].
Testing Type: Quantitative IgG antibody test [6]
Test Category: SEROLOGY
Test Name: LIAISON SARS-CoV-2 S1/S2 IgG [6]
Clinical Application & Need: Identify presence of IgG antibodies in patients who have been infected by SARS CoV-2 [7].
Age of Company: 1968 [2]

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