PerkinElmer Wins EUA to Test Asymptomatic People

PerkinElmer is targeting asymptomatic people in its latest testing offering for COVID-19 testing. The Waltham, MA-based company said it has received emergency use authorization from FDA for its Nucleic Acid Detection Kit to test individuals without symptoms or other reasons to suspect COVID-19 infection.

Here is the issue. About 60% of total COVID-19 transmissions come from those who have no symptoms, signaling that silent spreaders are the ones most often passing the virus around without knowing it, according to a new model from The Journal of the American Medical Association’s Open Network developed by researchers from the Centers for Disease Control and Prevention.

The Waltham, MA-based company said based on comparative data released by FDA the test kit has the lowest Limit of Detection (LoD) among the authorized COVID-19 molecular diagnostic tests reported, deeming it the most sensitive assay.

“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,” Masoud Toloue, PhD, Vice President & General Manager, Diagnostics, PerkinElmer, said in a release. “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.”

LabCorp was one of the first companies MD+DI reported about receiving an indication for asymptomatic testing. In July of 2020, FDA said it reissued the LabCorp COVID-19 RT-PCR Test EUA to expand the use of the test to anyone after the company provided scientific data showing the test’s ability to detect SARS-CoV-2 in a general, asymptomatic population.

The Burlington, NC-based has had EUA for its SARS-CoV-2 tests since the onset of the pandemic in the U.S.

Original Article: (https://www.mddionline.com/ivd/perkinelmer-wins-eua-test-asymptomatic-people)