Roche has begun to roll out its high-throughput antigen test for COVID-19 across Europe, with plans to ramp up production to “a double-digit million number of tests per month” to help meet international demands by early next year.
The company received a CE Mark for the automated laboratory diagnostic it first announced in mid-October, which is designed to relieve some of the burden on molecular-based tests that have served as the gold standard for detecting active coronavirus infections since the beginning of the pandemic.
The Elecsys antigen test uses deep nasopharyngeal or oropharyngeal swab samples collected by healthcare professionals, similar to PCR diagnostics, and clinical studies have shown a 5.5% rate of false-negative results and a false-positive rate of 0.1%, according to Roche.
“Healthcare systems remain under significant pressure to deliver robust testing options, with a sufficient number of tests available,” Roche Diagnostics CEO Thomas Schinecker said in a statement. “The launch of our high-throughput antigen test will provide additional testing capacity to reliably support healthcare systems in diagnosing SARS-CoV-2 infection, as a supplement to PCR testing.”
The test runs on the company’s cobase immunochemistry analyzers, at up to 300 tests per hour. The company has also filed the diagnostic for review with the FDA.
Roche previously launched an antigen test designed to deliver individual results at the point of care within 15 minutes. In September, it outlined plans to begin shipping 40 million of those tests to Europe, before increasing production to about 80 million per month by the end of this year.
The latest lab-based version, meanwhile, completes the set of Roche’s different types of coronavirus tests and their respective use cases: the company now offers PCR, antibody and antigen tests available for both high-throughput processing in a laboratory as well as near the patient with rapid, point-of-care results.
Earlier this month, Roche received an FDA authorization for a new, sensitive antibody test capable of measuring concentrations and gauging a person’s potential immunity to the novel coronavirus. The company also announced it would supply Moderna with the test, to help measure the success of its vaccine.