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FDA Grants Emergency Use Authorization for Nanobiosym PCR COVID-19 Test

NEW YORK — The US Food and Drug Administration this week granted Emergency Use Authorization for Nanobiosym Precision Testing Services' Nano Test for COVID-19.

The RT-PCR-based test is designed for the qualitative detection of nucleic acid from SARS-CoV-2 in saliva specimens self-collected at home using Nanobiosym's Nano-Saliva Collection Kit. It is based on the FDA-authorized PerkinElmer New Coronavirus Nucleic Acid Detection Kit, which targets the N and ORF1ab gene of SARS-CoV-2.

Use of the Nano Test for COVID-19 is limited to Cambridge, Massachusetts-based Nanobiosym, according to the FDA.