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Boston Heart Diagnostics Coronavirus Test Gets FDA Emergency Use Authorization

NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization for a SARS-CoV-2 test developed by Boston Heart Diagnostics (BHD).

The Boston Heart COVID-19 RT-PCR Test is designed to detect the SARS-CoV-2 ORF1ab, S, and N genes in upper respiratory specimens, nasopharyngeal aspirate, and bronchoalveolar lavage specimens. Nucleic acid extraction is performed using Thermo Fisher Scientific's MagMax Viral/Pathogen Nucleic Acid Isolation Kit, and the test runs on Thermo Fisher's QuantStudio 12K Flex Real-Time PCR System.

The test may be performed only by Framingham, Massachusetts-based BHD, which is a subsidiary of Eurofins Scientific.