News and analysis on diagnostic technologies and applications.
MicroGen Dx's Texas-based lab is the only commercial laboratory in the US offering sputum testing for SARS-CoV-2.
The point-of-care test kit, intended for professional use, delivers clinical results within 10 minutes, Beroni said.
The company's approach relies on an initial point-of-care lateral flow assay followed by a confirmatory real-time PCR analysis run in its laboratories.
The exemptions were granted to the Philips IntelliSite Pathology Solution and Leica's Aperio ImageScope DX Viewer.
The test, run on the BD Max system, allows hospitals to diagnose SARS-CoV-2 on site and receive results in less than three hours.
