Winter is coming, and so is Roche’s SARS-CoV-2 Rapid Antigen Test. Gaining European CE mark today, the Swiss company has joined Abbott in coming up with a 15-minute test for Covid-19 infection ahead of the annual flu and cold season. Rapid testing at this time of year will prove invaluable in determining whether people have Covid-19 or flu, helping to relieve pressure on healthcare systems before an expected winter rise in infections. Given the current demand for testing, scale-up is vital, and Roche intends to double its initial output of 40 million tests per month to 80 million by the end of the year. Roche’s EU nod comes less than a week after Abbott gained US authorisation for its BinaxNow rapid assay. But Roche is filing in the US, so despite the US government already committing to buy 150 million BinaxNow kits Roche could theoretically be a double winner. An initial focus on Europe could lead to large European government contracts, and with Abbott’s 2020 output largely committed to the US government Roche could take advantage of any overflow in US demand for rapid testing.
|Selected authorised Covid-19 antigen tests|
|Date of EUA/CE mark||Company||Test||Sensitivity||Specificity|
|September 1||Roche||SARS-CoV-2 Rapid Antigen Test||96.5%||99.7%|
|August 18||LumiraDx||LumiraDx Sars-CoV-2 Ag||97.6%||96.6%|
|July 2||Becton Dickinson||BD Veritor system for Sars-CoV-2||84.0%||100%|
|May 8||Quidel||Sofia Sars antigen FIA||96.7%||100%|
|Source: company statements.|