T2 Biosystems (TTOO) has announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its COVID-19 molecular diagnostic test, the T2SARS-CoV-2 Panel. Shares surged 19% in after-hours trading on the news.TTOO’s molecular diagnostic test detects the COVID-19 virus, SARS-CoV-2, and provides results in under two hours using a nasopharyngeal swab sample. It runs on the company’s fully-automated T2Dx Instrument, which can carry out seven tests simultaneously.Clinical testing on both positive and negative patient samples demonstrated a sensitivity of 95% and specificity of 100%, says the company.“We believe the Emergency Use Authorization for our COVID-19 …read more
Source:: Yahoo Finance