Coronavirus company news summary - FDA approves BD’s at-home test for emergency use - UK competition authority warns PCR test providers against breaching law - Verdict Medical Devices
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Coronavirus company news summary – FDA approves BD’s at-home test for emergency use – UK competition authority warns PCR test providers against breaching law

26 Aug 2021

The US Food and Drug Administration (FDA) has granted an Emergency Use Authorization (EUA) for BD‘s Veritor At-Home COVID-19 Test. Veritor is the first rapid antigen at-home Covid-19 test that leverages computer vision technology in a smartphone to read and deliver digital results within 15 minutes. It needs no prescription or laboratory and cuts down the results delivery time. The lateral flow test, which involves a nasal swab and Scanwell Health’s mobile app, can be used for self-testing by people aged 14 years and above.

The UK’s Competition and Markets Authority (CMA) has warned PCR Covid-19 test providers against breaching consumer protection law over misleading advertisements and potential failures to deliver results. In an open letter, the agency said that if customers are misled or not treated fairly, test providers could face enforcement action. The practices of concern noted by CMA include advertising prices that exclude additional charges or tests with limited or no availability, and no refunds for delays of results.

ID Genomics has developed a rapid test that could detect several genetic SARS-CoV-2 variants simultaneously. The company has received a US National Institutes of Health (NIH) grant to fast-track its dipstick-based, field-deployable test to the market. Within two hours, the test can simultaneously ‘fingerprint’ all presently identified variants of concern or interest such as Alpha, Beta, Gamma, Delta, Delta-plus, Epsilon and Lambda. It is also said to have the potential to spot new variants’ emergence. The test will not need any costly instrumentation and can be swiftly rolled out at epidemiological surveillance labs worldwide.