Roche’s test will launch late this month in Europe, initially making 40 million tests available per month. The Swiss pharma and diagnostics giant plans to also seek an emergency use authorization from U.S. FDA, and will double production by the end of the year.
The test can provide results within 15 minutes. It has a sensitivity of 96.52% (positive percent agreement) and a specificity of 99.68% (negative percent agreement), based on 426 samples from two independent study centers, according to Roche.
Roche is launching the rapid antigen test in partnership with SD Biosensor, with whom Roche has a global distribution agreement
“Especially in the upcoming flu season, it is important to know whether a person has SARS-CoV-2 or the flu to ensure the right course of treatment. COVID-19 testing solutions that provide healthcare professionals and patients with a quick answer regarding their infection status are critical to contain the community-spread of the COVID-19 virus,” Roche Diagnostics CEO Thomas Schinecker said in a news release.