PerkinElmer Receives Emergency Use Clearance From FDA for SARS-CoV-2 Respiratory Panel



WALTHAM, Mass .– (COMMERCIAL THREAD) –PerkinElmer, Inc. (NYSE: PKI) today announced that the United States Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for the PKamp â„¢ Respiratory SARS-CoV-2 RT-PCR Panel 1 trial. Qualified laboratories can immediately begin using this unique test for the simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus (RSV) isolated from nasopharyngeal swabs. , anterior nasal swabs and swabs of the middle turbinate.

COVID-19, influenza, and RSV infections are highly contagious and often cannot be differentiated based on symptoms alone. United States Centers for Disease Control and Prevention encourages COVID-19 testing labs will adopt a multiplex method that facilitates detection and differentiation of SARS-CoV-2 and influenza viruses. A multi-analyte test such as Respiratory PKamp SARS-CoV-2 RT-PCR Panel 1 The test allows laboratories to conserve valuable resources by avoiding multiple testing of samples taken from individuals with suspected respiratory viral infection compatible with COVID-19.

“As we enter flu season, this timely emergency use authorization will be welcomed by laboratories looking to test common respiratory illnesses alongside COVID-19, ”said Arvind Kothandaraman, Director general specialist diagnostics at PerkinElmer. “The new test will help ease the confusion resulting from similar symptoms caused by these infections and reduce the additional strain on the healthcare system during a pandemic. ”

Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 USC § 263a, which meet the requirements for performing high complexity tests.

PerkinElmer is also CE marked for a multi-analyte respiratory panel that tests for COVID-19 – the SARS-CoV-2 PKamp â„¢ Respiratory RT-PCR Panel The test is authorized for sale as an in vitro diagnostic (IVD) device in more than 30 countries by meeting the requirements of the European Directive on In Vitro Diagnostics (IVDD).

PerkinElmer’s complete SARS-CoV-2 portfolio includes high throughput RNA extraction, RT-PCR, workflow automation, ELISA, chemiluminescence, fluorescence time resolved and lateral flow based antigen as good as serology trial.

About PerkinElmer

PerkinElmer empowers scientists, researchers and clinicians to tackle their most critical challenges in science and health. With a mission to innovate for a healthier world, we provide unique solutions to serve the diagnostic, life science, food and application markets. We work in strategic partnership with our clients to obtain earlier and more precise information, supported by in-depth market knowledge and technical expertise. Our dedicated team of approximately 15,000 employees worldwide is passionate about helping customers work to create healthier families, improve quality of life, and maintain the well-being and longevity of people around the world. The company reported 2020 sales of approximately $ 3.8 billion, serves clients in 190 countries, and is included in the S&P 500 Index. Additional information is available at www.perkinelmer.com.


Previous Mobile phlebotomy company VeniExpress expands further in Arizona for service
Next China to deepen preferential lending rate reforms - central bank official

No Comment

Leave a reply

Your email address will not be published.