George Washington University
The company had to step back from an initial focus on cardiovascular disease but believes its new target will have an easier path to market.
FDA Grants Emergency Use Authorization for George Washington University Coronavirus PCR Test
Use of the test, which detects viral nucleic acid in upper respiratory specimens and bronchoalveolar lavage, is limited to George Washington University.
The company is collecting validation evidence it intends to submit to the FDA next year, which will also support launch of the test as an LDT.
The study found that central laboratory troponin and chemistry testing dropped by half, and POC testing improved care.