Roche scored a major win with the FDA’s backing for its COVID-19 antibody tests last week in a field marked by products of questionable quality. Now, to cover its booming production goals, Roche plans to infuse nearly half-a-billion dollars into its German manufacturing facility.
Roche will plow $459 million into its manufacturing facility in Penzberg, Germany, to boost production of the antibody test that won an emergency use authorization from the FDA last week, Reuters reported.
At a German Ethics Council meeting Monday, officials said the government had signed a deal with Roche to secure 3 million diagnostic tests in May and an additional 5 million each following month. Eventually, Roche will aim to produce nearly 100 million tests per month by the end of 2020, according to Reuters.
Roche is reportedly also working on a four-year plan to develop a brand-new research and diagnostic center.
After the FDA approval Friday, Roche said it is prepared to produce “high double-digit millions” of the tests in May with the intent to continue ramping up production.
Roche began testing its antibody diagnostic, which runs on its high-throughput Elecsys assay platform and cobas line of analyzers, in mid-April.
During a first-quarter earnings call with analysts late last month, Roche CEO Severin Schwan blasted the current state of COVID-19 serology tests, calling many of the diagnostics “amateur.”
“These tests are not worth anything, or have very little use,” Schwan said at the time. “Some of these companies, I tell you, this is ethically very questionable to get out with this stuff.”
Roche has not only scored an emergency use nod for antibody tests but also for a fully automated molecular test for active COVID-19 patients.
The FDA authorized Roche’s diagnostic test in mid-March, just 24 hours after receiving the application. Previously, the FDA had only allowed specific, certified laboratories to use their preapproved and validated diagnostics in identifying COVID-19 patients.
Now, this latest Emergency Use Authorization enables clinicians to run the Roche test on the company’s cobas 6800/8800 molecular testing systems, widely available at hospitals and labs throughout the country. It is also available in European countries accepting the CE mark.