EUROIMMUN Receives CE Mark for New PCR Test to Differentiate Between COVID-19 and Flu
Company expands testing portfolio for acute diagnostics of COVID-19
WALTHAM, Mass. – December 14, 2020 – EUROIMMUN, a PerkinElmer, Inc. Company, today announced the launch of the CE marked EURORealTime SARS-CoV-2/Influenza A/B for direct detection of SARS-CoV-2, influenza virus type A and influenza virus type B. It expands the testing portfolio for acute COVID-19 diagnostics by supporting differential diagnostics between SARS-CoV-2 infections and the common flu. It is available in countries accepting the CE mark.
PCR technology is considered the gold standard for direct pathogen detection. The new EURORealTime test allows fast detection and differentiation of genetic material from SARS-CoV-2, influenza virus type A and influenza virus type B using throat swab samples of patients with acute symptoms, which can be indicative for COVID-19 or flu. Validation efforts revealed very high agreement of results obtained with the EURORealTime test and those obtained with reference PCR tests for SARS-CoV-2 and influenza A/B. No cross-reactions with other common respiratory pathogens were detected. The assay is compatible with common real-time PCR thermal cyclers, while the EURORealTime Analysis Software allows for reliable and standardized evaluation of the test results.
“As the flu season overlaps with the second wave of COVID-19, there is an increasing need to be able to quickly distinguish between SARS-CoV-2 and influenza infections. Individuals with these viral diseases can present with very similar symptoms which makes it difficult to differentiate between them. Here, direct pathogen detection plays a major role in rapid and correct identification of these infections as it is essential for proper subsequent patient management,” says Dr. Wolfgang Schlumberger, CEO of EUROIMMUN. “The combination of the three pathogens within this single multiparametric assay means saving valuable time and resources in the laboratories.”
The EURORealTime SARS-CoV-2/Influenza A/B assay adds to the Company’s broad product portfolio of COVID-19 diagnostics and is the second molecular assay for direct pathogen detection following the CE-marked and FDA-EUA approved EURORealTime SARS-CoV-2 assay. The EURORealTime SARS-CoV-2/Influenza A/B assay complements PerkinElmer’s PKamp™ Respiratory SARS-CoV-2 RT-PCR Panel that previously received the CE mark.
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 14,000 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 $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.