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November 11, 2021

Coronavirus company news summary – FDA classifies Ellume test recall as Class 1 – GoMeyra partners with Alliance Health to boost US testing capacity

By Chris Lo

The US Food and Drug Administration (FDA) has classified the recall of Ellume’s Covid-19 test as Class 1, marking it as the most serious kind of recall. Last month, the company recalled some batches of its COVID-19 Home Test due to increased rates of false-positive test results. The FDA received 35 reports of false-positive results associated with the over-the-counter antigen test. In December last year, the test received Emergency Use Authorization from the FDA for use in individuals aged two years and above to detect Covid-19 using a nasal sample. To date, 2,212,335 tests have been recalled in the US.

GoMeyra has entered a collaboration with Alliance Health to boost its Covid-19 testing capabilities. Alliance Health, with facilities in New York and Florida, US, provides walk-in, mobile, drive-through and onsite testing services. Use of GoMeyra’s Laboratory Information Management Solution (LIMS) is intended to help Alliance Health handle more samples. LIMS is a cloud-based system that offers fast processing times for Covid-19 reverse transcription-polymerase chain reaction (RT-PCR), antibody, antigen, rapid PCR as well as serology testing, GoMeyra said.

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to Meridian Bioscience’s Revogene SARS-CoV-2 assay. The test is intended to qualitatively identify the SARS-CoV-2 virus using nasopharyngeal, anterior nasal, oropharyngeal as well as mid-turbinate nasal swab samples. With a positive percent agreement and a negative percent agreement of 97.7%, the test can deliver a positive result in just 47 minutes. The company plans to commence shipping of the molecular diagnostic tests before the end of 2021.

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