FDA Grants EUA To PerkinElmer's SARS-CoV-2 RT-PCR Assay For Asymptomatic Testing - Quick Facts

(RTTNews) - PerkinElmer, Inc. (PKI) announced Thursday that its PerkinElmer New Coronavirus Nucleic Acid Detection Kit received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to test individuals without symptoms or other reasons to suspect COVID-19 infection.

For asymptomatic carriers, diagnostic testing is essential to identify infected individuals, and thereby provides a better chance of getting infectious individuals into isolation to avoid spreading the disease further.

Based on comparative data released by the FDA, the PerkinElmer test kit has the lowest Limit of Detection (LoD) among the authorized COVID-19 molecular diagnostic tests reported, deeming it the most sensitive assay. PerkinElmer's SARS-CoV-2 RT-PCR assay originally obtained FDA EUA in the spring of 2020.

The Company's comprehensive SARS-CoV-2 offerings span high throughput RNA extraction, RT-PCR, automation, ELISA, chemiluminescence, time-resolved fluorescence and lateral flow based serology testing.