PerkinElmer Obtains CE Mark For PKamp Respiratory SARS-CoV-2 RT-PCR Panel

(RTTNews) - PerkinElmer, Inc. (PKI) said Monday that its PKamp Respiratory SARS-CoV-2 RT-PCR Panel has received clearance to be marketed as an in vitro diagnostic or IVD device in more than 30 countries as it met the requirements of the European In Vitro Diagnostic Directive or IVDD.

The company noted that the test is currently under review by the U.S. FDA for Emergency Use Authorization or EUA.

The multi-analyte panel will enable labs to detect and differentiate between SARS-CoV-2, influenza A viruses, influenza B viruses and respiratory syncytial virus (RSV) in a single test. This is seen as critical to manage the surge in test demand during the flu season as the targeted pathogens have some similar signs and symptoms.

Instead of running multiple tests on samples, the PKamp Respiratory SARS-CoV-2 RT-PCR Panel is designed to conserve resources by testing a single nasopharyngeal, oropharyngeal or nasal swab sample collected from individuals suspected of respiratory viral infection consistent with COVID-19, the flu and RSV.

"In the next few months, it will be vital for health professionals to detect and differentiate between COVID-19, the common flu and RSV infection. By offering an automated multi-analyte testing solution, we are equipping diagnostics labs with the right toolset to tackle the additional pressure the season may have on this pandemic," said Masoud Toloue, Vice President and General Manager of Diagnostics, PerkinElmer.