Back in March, the US Food and Drug Administration (FDA) stated that the newly liberalized clearance scheme it was deploying to expedite the COVID-19 diagnostic testing pipeline did not apply to at-home testing due to concerns about the marketing of fraudulent test kits. However, the agency seems to have reversed that policy and recently broke new ground by authorizing coronavirus testing by multiple laboratories in nasal samples collected by consumers using an at-home kit. The Rutgers and LabCorp Assays At-home sample collection of COVID-19 test samples also some obvious advantages over the standard method in which a qualified health care professional armed to the teeth in personal protective equipment inserts a swab into the nostrils to access and perform a tissue scrape of the nasopharynx at the back of the nasal cavity. On April 13, the FDA granted Emergency Use Authorization (EUA) to the Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2 Assay, version of the Thermo Fisher Scientific Applied Biosystems TaqPath COVID-19 Combo Kit modified to allow for testing on saliva samples that can be collected at home. Just over a week later, the agency gave LabCorp the go-ahead for at-home sample collection. However, these approvals of at-home sample collection had […]