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

EUROIMMUN US Inc. (United States subsidiary of EUROIMMUN AG)

Business Name:
EUROIMMUN US Inc. (United States subsidiary of EUROIMMUN AG)
Business Genre:
Business Description:

EUROIMMUN US, Inc., a subsidiary of EUROIMMUN and specialize in medical diagnostics.The company prides itself in its strategic product development in which designer antigens, as well as patented and licensed technologies, play an important role. They work to expand product offerings with new assays to aid in the detection of antibodies associated with autoimmune diseases, infectious diseases, and allergy.  EUROIMMUN is an FDA registered facility and is ISO 9000 certified. EUROIMMUN US, Inc. has obtained a significant number of product clearances from the FDA with the majority of products also carrying CE marking [1].

City:
Mountain Lakes
State:
NJ
Country:
EUROIMMUN AG HQ in Lübeck, Schleswig-Holstein, Germany [2].
Data/Evidence of Effectiveness:
99% specificity and 100% sensitivity after 21 days following the onset of symptoms [3]. Earlier time points do not have have good accuracy results as addressed by the company.
Complimentary Products Needed to Perform Test:
“Automatic microplate washer: recommended. Washing of the microplates can also be carried out manually [5]. • Microplate reader: wavelength of 450 nm, reference wavelength range from 620 nm to 650 nm • Calibrated pipettes • Pipette tips • Stepper pipette: recommended for the pipetting of enzyme conjugate, substrate, and stop solution • Distilled or deionized water • Incubator: for incubation of the microplate at +37°C • Incubator or water bath: recommended to warm the wash buffer • Stop watch [5].”
Setting of Care:
Authorized setting H- Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests [4].
Current Status / Clinical Development Stage / Expected Milestones:
Not FDA cleared/approved; FDA approved to meet EUA criteria [2]. Under EUA, cGMP requirements have been waived [2]; for in vitro diagnosis of SARS-CoV-2 infection [2]. Currently available for purchase [6]
Funding & Ownership :
Private, For profit company [2].
Business Model:
EUROIMMUN develops and manufactures medical laboratory reagents for the diagnosis of autoimmune and infectious diseases and allergies [1-2].
IP:
N/A
History & Origins :
Company was established in 1987. They have since, catered to improve healthcare by delivering innovative, clinically relevant diagnostic assays that aid in the diagnosis of autoimmune and infectious diseases. Worldwide, EUROIMMUN offers one of the most extensive test menus in a variety of technology platforms: IFA BIOCHIP Mosaics, ELISA, Immuno/Western blot, EUROLine, EUROArray, and EUROPattern/IFA automation [1].
Date EUA Issued:
5/4/2020 [4].
Sources:
1. https://www.euroimmun.us/about 2. https://www.crunchbase.com/organization/euroimmun-ag#section-overview 3. https://www.euroimmun.us/fda-released/fda-provides-emergency-use-authorization-to-perkinelmer-for-serological-test-to-identify-covid-19-antibodies 4. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#covidinvitrodev 5. https://www.fda.gov/media/137609/download 6. https://www.euroimmun.us/contact
Organization:
Chief Executive Officer: Mr. Hamid Erfanian [6]
No. Tests Per Day:
93 patient samples in 2.5 hours. So fo 24 hours, (93 x 24)/2.5 = 892.8 tests
Time to Result:
~ 2.5 hours [5]. Can run up to 93 patient samples in 1 plate (+3 controls) [5].
Test Sample Type:
Serum, Plasma [5].
Technology Overview:
ELISA using S1 spike antigen coated wells to detect neutralizing antibodies [5]. Antibodies against S1 antigen are more likely to represent neutralizing antibodies than those produced against N capsid nucleoprotein antigen [3].
Testing Type:
IgG serology test [5]. Qualitative detection of IgG class antibodies [5].
Test Category:
SEROLOGY
Test Name:
EUROIMMUN Anti-SARS-CoV-2 ELISA (IgG) [3, 5]
Clinical Application & Need:
“Aids in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection [5].”
Age of Company:
1987 [1]

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