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MicroGen Dx's Texas-based lab is the only commercial laboratory in the US offering sputum testing for SARS-CoV-2.
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.
After validating its pathogen detection platform for multiple viruses, the firm aims to initially offer a point-of-care diagnostic testing panel by the third quarter.
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.
The assay, which resembles a pregnancy test, is authorized for use in laboratories certified under CLIA to perform as moderate- and highly-complexity tests.
The test is designed to detect SARS-CoV-2 nucleic acid in nasopharyngeal and oropharyngeal swab specimens from individuals suspected of having COVID-19.
The company said the revenue increase is driven primarily by growth in the life science segment due to high demand for SARS-CoV-2 molecular products.
Under the guidance, only the laboratory that developed the test can perform it if the lab is CLIA-certified to perform high-complexity tests.
If the proposal is finalized, the tests will go through a less burdensome process to obtain marketing clearances.