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DxLab Receives FDA Emergency Use Authorization For RT-LAMP COVID-19 Test

NEW YORK – The US Food and Drug Administration last week granted DxLab Emergency Use Authorization for its molecular DxLab COVID-19 test. 

The RT-LAMP test, which uses anterior nasal swab samples, is performed using the Somerville, Massachusetts-based company's DxHub instrument. The qualitative assay is intended for patients suspected of having COVID-19 by their healthcare provider or for people without symptoms or epidemiological reasons to suspect they have COVID-19 when they are tested twice over three days with at least 24 hours between tests, the FDA said. 

The test is authorized for use in CLIA-certified labs or at the point of care in CLIA-waived settings.

The DxHub instrument is a tabletop device with eight separate test bays that allow up to eight samples to be processed and returns results in 25 minutes or less, according to the firm's website. 

The Scan

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