EUROIMMUN Anti-SARS-CoV-2 S1 Curve ELISA Receives FDA Emergency Use Authorization

Rhea-AI Summary

PerkinElmer has received Emergency Use Authorization (EUA) from the U.S. FDA for its Anti-SARS-CoV-2 S1 Curve ELISA (IgG). This assay enables the qualitative and semi-quantitative detection of IgG antibodies against the SARS-CoV-2 S1 antigen in human serum and plasma. It is designed for use by CLIA-certified laboratories and plays a critical role in vaccine development and research on immunity. The assay can be used manually or on various ELISA platforms, enhancing laboratory capabilities in understanding COVID-19 immunity.

Positive

• EUA from the U.S. FDA for the Anti-SARS-CoV-2 S1 Curve ELISA (IgG) indicates regulatory approval, potentially boosting demand.
• The assay's qualitative and semi-quantitative detection could advance vaccine development and research efforts.
• Availability for CLIA-certified laboratories could expand the usage and market reach of the product.

Negative

• None.

Assay enabling the measurement of IgG antibodies could yield future discoveries and insights on immune responses to SARS-CoV-2

WALTHAM, Mass.--(BUSINESS WIRE)-- EUROIMMUN, a PerkinElmer, Inc. company (NYSE: PKI), announced today that the U.S. Food and Drug Administration has provided Emergency Use Authorization (EUA) for its Anti-SARS-CoV-2 S1 Curve^TM ELISA (IgG). This assay allows for the qualitative and semi-quantitative detection of IgG antibodies formed against the SARS-CoV-2 S1 antigen, in human serum and plasma. Clinical laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) can immediately begin using this ELISA for the detection of antibodies of the immunoglobulin class G.

The Anti-SARS-CoV-2 S1 Curve ELISA (IgG) – based on EUROIMMUN’s Anti-SARS-CoV-2 QuantiVac^TM ELISA (IgG) that received CE mark in November 2020 – measures the concentration of antibodies against the S1 domain of the spike protein including the receptor binding domain (RBD), which represents an important target antigen for virus neutralizing antibodies. Due to the low protein homologies within the coronavirus family, the existence of IgG antibodies specifically indicates recent or prior infection and is to be used as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. For this reason, S1 based tests play a critical role in ongoing vaccine development programs and in research efforts to examine the immunity of individuals previously infected by SARS-CoV-2.

“Assays that enable the detection of IgG antibodies are an important tool in the arsenals of scientists and researchers working to understand the nature of SARS-CoV-2 and prevent the spread of other highly infectious viruses like it in the future,” said Dr. Wolfgang Schlumberger, CEO of EUROIMMUN. “With this latest EUA of our semi-quantitative antibody test, more laboratories will have the ability to generate in-depth insights on immunity that advance future antibody therapies and vaccines for COVID-19.”

The assay can run manually or using the EUROLab^TM Workstation ELISA, Sprinter XL^TM and other third party ELISA platforms.

The Anti-SARS-CoV-2 S1 Curve ELISA (IgG) is one of many solutions in EUROIMMUN’s SARS-CoV-2 specific portfolio, which also includes real-time PCR tests, an antigen detection assay and multiple antibody tests, a dried blood spot solution, as well as automation systems for small, medium and high sample throughput.

About PerkinElmer

PerkinElmer enables scientists, researchers, and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food, and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 15,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $3.8 billion in 2020, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available at www.perkinelmer.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211005006175/en/

Media Relations:

Chet Murray

(781) 663-5728

chet.murray@perkinelmer.com



Investor Relations:

Steve Willoughby

(781) 663-5677

steve.willoughby@perkinelmer.com

Source: PerkinElmer, Inc.

FAQ

What is the significance of the Emergency Use Authorization for PKI?

The Emergency Use Authorization allows PerkinElmer's Anti-SARS-CoV-2 S1 Curve ELISA (IgG) to be used in clinical laboratories, facilitating COVID-19 antibody testing.

When was the EUA granted for the Anti-SARS-CoV-2 S1 Curve ELISA by the FDA?

The EUA for the Anti-SARS-CoV-2 S1 Curve ELISA was granted on October 5, 2021.

How does the Anti-SARS-CoV-2 S1 Curve ELISA (IgG) work?

The assay allows for the qualitative and semi-quantitative detection of IgG antibodies in human serum and plasma, helping identify immune responses to SARS-CoV-2.

What role does the new assay play in vaccine development?

The assay is critical for understanding antibody responses, which can inform vaccine efficacy and development strategies.

Which laboratories can use the Anti-SARS-CoV-2 S1 Curve ELISA (IgG)?

The assay can be used by clinical laboratories that are certified under the Clinical Laboratory Improvement Amendments (CLIA).