Roche (OTCQX:RHHBY +1.8%) plans to launch its SARS-CoV-2 Rapid Antigen Test later this month in markets that accept CE Mark certification.
It expects to file for emergency use authorization in the U.S.
The point-of-care chromatographic assay can generate a result in 15 minutes without the need for instrumentation. The company says it has 96.5% sensitivity and 99.7% specificity based on 426 nasopharyngeal swab samples from two independent study centers.
At launch, production volume will be 40M units per month which will ramp to more than 80M per month by year-end.
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