FDA authorises two new Covid-19 approaches

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Of the five molecular tests for the pandemic virus authorised by the US FDA last week, the second-most interesting is that from the Danaher subsidiary Cepheid. The assay is the first to test simultaneously for the coronavirus, flu and respiratory syncytial virus, and may be used at the point of care, yielding results in 35 minutes. Pricing will be watched closely. Cepheid was accused of profiteering by Médecins sans Frontières in July after it priced its earlier Covid-19 test at $20 in developing countries; MSF said the assay could be sold at a profit in these territories at just $5 per test. The most interesting authorisation of all, however, comes from Clear Labs, whose core business involves using high-throughput sequencing to detect genetic material from pathogens in food samples. Swerving into healthcare, the company has obtained authorisation for the first nanopore sequencing-based test for Covid-19. This technique can allow a single molecule of viral RNA to be sequenced without the need for amplification or chemical labelling of the sample, potentially allowing faster and cheaper results. Clear Labs' test runs on Oxford Nanopore’s GridIon sequencer.

Please note: the graph above now takes account only of the first time a test was authorised and does not include reauthorisations, to avoid double counting. It includes tests from academic and government laboratories as well as commercial tests. "Other" includes four antigen tests, three home sampling kits and one IL-6 test.

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