Nexus’s COVID-19 Test Kit Gets FDA’s Emergency Use Authorization

Watertown, Mass.-based Nexus Medical Labs has received the FDA’s Emergency Use Authorization for its COVID-19 test kit.

The Nexus High Throughput SARS-CoV-2 Assay is authorized for the qualitative detection of nucleic acid from SARS-CoV-2 in anterior nasal swab specimens. The samples are collected using the Rhinostics nasal swab collection kit from individuals who are suspected by a healthcare provider of being infected with COVID-19. Samples can be collected by the healthcare provider or they can be self-collected by adults aged 18 and older.

Analysis of the tests is limited to the Aldatu Diagnostics laboratory in Watertown, Mass., which is certified under the Clinical Laboratory Improvement Amendments of 1988 to perform high complexity tests.