In a New First, FDA Permits Marketing of COVID-19 Test Through Traditional Premarket Review Process
The FDA says data was reviewed from a clinical study of more than 500 test samples and a variety of analytical studies, which demonstrated a reasonable assurance that this COVID-19 test was safe and effective at identification and differentiation of various respiratory viral and bacterial pathogens.
FDA Issues Second EUA for Whole Genome Sequencing COVID-19 Diagnostic Test
Next-generation sequencing (NGS)-based test reportedly diagnoses the presence of COVID-19 and also provides information about viral variants.