PerkinElmer SARS-CoV-2 RT-PCR Assay Receives FDA EUA for Asymptomatic Testing

(Waltham, MA; USA) has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for the PerkinElmer New Coronavirus Nucleic Acid Detection Kit 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. The ability to quickly identify asymptomatic individuals provides significant public health value. Moreover, 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 RT-PCR assay originally obtained FDA EUA in the spring of 2020. Previously, the FDA issued EUA to allow sample pooling with the PerkinElmer New Coronavirus Nucleic Acid Detection Kit to increase the number of individuals who can be tested without increasing resources. Additional testing mechanisms, including the use of saliva as a sample type, are also on the horizon.

“The data is clear – it’s imperative we have reliable and accurate testing for asymptomatic individuals, especially as we’re seeing new strains of the virus appear that are even more contagious,” said Masoud Toloue, Ph.D., Vice President & General Manager, Diagnostics, PerkinElmer. “PerkinElmer is in a unique position to help this cause, as we’re one of the few suppliers to have an EUA for asymptomatic testing, maintain the most sensitive test on the market along with a strong supply chain, and have the capability to do sample pooling to save time and resources for diagnostic laboratories.”