PerkinElmer (NYSE:PKI) announced today that it received FDA emergency use authorization (EUA) for its PKamp respiratory panel 1 assay.
Qualified laboratories can now use Waltham, Massachusetts–based PerkinElmer’s PKamp respiratory SARS-CoV-2 RT-PCR panel 1 assay to simultaneously test for several serious respiratory ailments. The assay can detect SARS-CoV-2 (the virus causing COVID-19), influenza A, influenza B and respiratory syncytial virus (RSV) isolated from nasopharyngeal swabs, anterior nasal swabs and mid-turbinate swabs.
The company said in a news release that a multi-analyte test such as the PKamp assay allows laboratories to conserve precious resources by avoiding multiple tests on samples collected from individuals suspected of respiratory viral infection consistent with COVID-19.
PerkinElmer also holds CE mark approval for a multi-analyte respiratory panel that tests for COVID-19. The PKamp assay has clearance to be marketed as an in vitro diagnostic (IVD) device in more than 30 countries in Europe.
“As we enter the flu season, this timely emergency use authorization will be welcome by laboratories that are looking to test for common respiratory illnesses alongside COVID-19,” PerkinElmer managing director of specialty diagnostics Arvind Kothandaraman said in the release. “The new test will help to alleviate confusion arising from similar symptoms caused by these infections and reduce further strain on the healthcare system during a pandemic.”