FDA Watch: Agency to Use EUA Pathway to Clear New Coronavirus Detection Tests

There are no FDA-cleared tests to detect the new 2019-nCoV Wuhan coronavirus. But on Jan. 28, the agency unveiled its strategy to promote the rapid development and availability of safe and effective investigational medical products “to address this urgent public health situation.” As with previous infectious disease outbreaks like Zika, the FDA will clear new 2019-nCoV tests and treatment products on an expedited basis via the Emergency Use Authorization (EUA) pathway. The FDA is calling on diagnostic test sponsors interested in potential EUA for detection tests to contact the Center for Devices and Radiological Health (CDRH) (CDRH-EUA-Templates@fda.hhs.gov) for information and templates. The FDA has also created a landing page to keep product developers and the public informed about the outbreak and the FDA’s response measures. New FDA Approvals Key new product approvals announced from late December 2019 through late-January 2020: NEW FDA APPROVALS Manufacturer(s) Product(s) DNA Genotek (subsidiary of OraSure Technologies) 510(k) clearance for Oragene Dx sample collection kits Geneoscopy Breakthrough device designation for colorectal cancer screening test based on extraction of stool-derived eukaryotic RNA transcripts KDx Diagnostics Breakthrough device designation for URO17 Bladder Cancer Recurrence Test Luminex Clearance for NxTag Respiratory Pathogen Panel qualitative test run on firm’s Magpix instrument to […]