emergency use authorization approved

QDx Pathology Services Earns Emergency Authorization for COVID-19 Test

February 11, 2021

QDx Pathology Services’ QDx SARS-CoV-2 Assay has received Emergency Use Authorization (EUA) from the FDA for detecting COVID-19 infections.

The reverse transcription polymerase chain reaction (RT-PCR)-based test uses nasal swab samples collected by the patient and is performed with the ChromaCode high-definition PCR assay test kit that received an EUA in June 2020.

After the nasal swab sample is collected using the product’s home collection kit, it must be sent for testing at the QDx Pathology Service laboratory in New Jersey.

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