JD Supra

COVID-19 update: Facilitating diagnostic test availability for asymptomatic testing, sample pooling

On June 16, the U.S. Food and Drug Administration (FDA) posted updates to their Molecular Diagnostic Templates for developers that intend their assay to be used for pooled patient samples or for ...
GEN

FDA Reissues EUA for PerkinElmer COVID-19 RT-PCR Test, Enabling Sample Pooling

The PerkinElmer New Coronavirus Nucleic Acid Detection Kit. PerkinElmer’s COVID-19 test kit has received a reissued Emergency Use Authorization (EUA) from the FDA enabling its use through sample ...
Nasdaq

PerkinElmer COVID-19 Test Kit Receives FDA Emergency Use Authorization for Sample Pooling

WALTHAM, Mass.--(BUSINESS WIRE)-- PerkinElmer, Inc. (NYSE: PKI) announced today that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) to allow sample pooling ...
BioTechniques

The importance of sample pooling in COVID-19 testing

The rapid, widespread transmission of COVID-19 in many regions has put a significant strain on COVID-19 testing capabilities. With RT-PCR identified as the current gold standard for testing due to its ...
Business Wire

PerkinElmer SARS-CoV-2 RT-PCR Assay Receives CE Mark for Saliva and Sample Pooling to Test Symptomatic and Asymptomatic Individuals

WALTHAM, Mass.--(BUSINESS WIRE)--PerkinElmer, Inc. announced today that its PerkinElmer ® SARS-CoV-2 Real-time RT-PCR Assay received CE-IVD marking for the use of saliva as specimen type and the ...
Business Wire

PerkinElmer SARS-CoV-2 RT-PCR Assay Receives CE Mark for Saliva and Sample Pooling to Test Symptomatic and Asymptomatic Individuals

WALTHAM, Mass.--(BUSINESS WIRE)--PerkinElmer, Inc. (NYSE:PKI) announced today that its PerkinElmer ® SARS-CoV-2 Real-time RT-PCR Assay received CE-IVD marking for the use of saliva as specimen type ...