DxLab Gets FDA’s Emergency Use Authorization for Its COVID-19 Test

DxLab of Somerville, Mass. has received an Emergency Use Authorization from the FDA for its DxLab COVID-19 test.

The test is authorized for detection of nucleic acid from the SARS-CoV-2 coronavirus from nasal swab samples from individuals suspected by their healthcare provider of being infected with COVID-19, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19 infection.

The DxLab COVID-19 test is indicated for use twice over three days with at least 24 hours and no more than 48 hours between the tests.

The test is authorized for use in patient care settings with laboratories certified to perform high, moderate or waived complexity tests. As defined by the Clinical Laboratory Improvement Amendments of 1988 (CLIA), waived tests are simple tests with a low risk for an incorrect result.