Dive Brief:
- Roche's COVID-19 and influenza A/B test for use on the Swiss company's benchtop Cobas Liat system has received an emergency use authorization from the FDA.
- The rapid diagnostic, which gives results for single samples within 20 minutes, is the second EUA for the Roche combination test. The company's Cobas SARS-CoV-2 & Influenza A/B test, designed to run on its 6800/8800 systems and provide 96 results in about three hours, got FDA's nod earlier this month.
- With the approaching flu season, the latest EUA for the Roche test gives the new option of conducting rapid testing in either point-of-care or clinical laboratory settings to detect and differentiate between the viruses. It is the FDA's fifth emergency authorization for such a combination diagnostic.
Dive Insight:
FDA in July granted emergency authorization to a test developed by the Centers for Disease Control and Prevention to determine if a patient is infected with the flu or the novel coronavirus. The agency previously authorized similar combination tests from BioFire Diagnostics and Qiagen in the spring. However, the two EUAs Roche has received in as many weeks are the first for such a major testing manufacturer.
The latest EUA provides Roche with an authorized rapid diagnostic to help healthcare providers distinguish between the contagious respiratory illnesses caused by different viruses.
The test is to be used with provider-collected nasopharyngeal and nasal swabs and self-collected nasal swabs, collected in a healthcare setting with instruction by a provider, from individuals suspected of respiratory viral infection consistent with COVID-19, according to FDA.
The ability of Roche's system to provide results for single samples within 20 minutes in POC and clinical lab settings is a much faster combo test than the one authorized earlier this month. At the time, Roche claimed the EUA to be the first for a commercial diagnostic that runs on fully automated high-throughput systems and can discern between the three viruses in a single sample.
