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MedArbor Diagnostics Gets FDA Emergency Use Authorization for COVID RT-PCR Test

NEW YORK – MedArbor Diagnostics has obtained Emergency Use Authorization from the US Food and Drug Administration for an RT-PCR assay to detect SARS-CoV-2, the virus that causes COVID-19, the agency said last week.

MedArbor Diagnostics is a full-service COLA- and CLIA-accredited clinical laboratory located near Philadelphia.

The MedArbor Diagnostics SARS-CoV-2 Assay is authorized for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab, oropharyngeal swab, anterior nasal swab, mid-turbinate nasal swab, nasopharyngeal wash/aspirate, and nasal aspirate specimens from individuals suspected of COVID-19 by their healthcare provider.

Emergency use of the test is limited to MedArbor's laboratory in Bristol, Pennsylvania, according to the FDA's authorization letter.