Roche announced this week plans to launch a SARS-CoV-2 Rapid Antigen Test capable of 15-minute turnarounds for markets accepting the CE Mark and file for Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).
Meant for use in point of care settings — which allow healthcare professionals to operate outside of the lab — the test is usable on both symptomatic and asymptomatic patients, allowing quick diagnosis of those suspected to carry the virus. Small and instrument-free, the test kit is optimal for settings where resources are limited, thereby increasing access to testing capabilities.
“As the COVID-19 pandemic persists, healthcare systems remain challenged,” Thomas Schinecker, CEO of Roche Diagnostics, said. “Testing continues to be an important focus for many countries. 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.”
In partnering with SD Biosensor Inc., Roche will launch with the ability to provide 40 million rapid tests per month. It hopes to more than double that capacity by the end of the year. The test offers a sensitivity of 96.52 percent and a specificity of 99.68 percent — figures based on 426 samples pulled from two independent study centers.
The test is Roche’s tenth item in a portfolio built to test for and combat the COVID-19 pandemic.