Medical Device News Magazine

Thursday, March 23, 2023

Roche Launched a New Serological Antibody Test Made in Germany: Reports “99.8% Accurate”

Roche launched the new serological (antibody-based) test at the company’s Penzberg laboratory on Monday, May 4 at a press conference attended by German Health Minister Jens Spahn and Bavarian state premier Markus Söder. On May 3, the test received emergency approval from the US Food and Drug Administration.

According to Roche data, the test is 99.8 percent accurate – far better than other tests of its kind.

“This is not just a regional event – it’s an important international step in the fight against the coronavirus,” said Söder. “The solutions to the crisis will be scientific ones, and this is a major milestone.”

Spahn underscored that the test had set new standards in both specificity to the Sars-CoV-2 virus and the sensitivity of positive and negative results in those tested. He added that 3 million tests would be produced this month and 5 million per month in future for use in Germany. Roche said hundreds of millions of tests would be made available internationally wherever they’re needed.

“Tests like these are important to find out what percentage of the population have been affected beyond the official numbers thus far,” Spahn told reporters.

Roche says it plans to invest 400 million euros in its Penzberg facility, and Söder said the state of Bavaria would chip in 40 million of its own to expand operations there.

“The expansion by Roche is a great testimonial for Germany as Europe’s leading biotechnology location,” says Germany Trade & Invest (GTAI) Director of Chemicals and Health Marcus Schmidt. “With more than 5000 employees, Penzberg in southern Bavaria is already the Swiss pharmaceutical company’s largest biotech research, development and production center worldwide. We are also delighted to hear that the regional Bavarian government will further strengthen the greater Munich life-science cluster by funding a new pandemic research institute.”

GTAI Health Expert Gregor Kemper pointed out that Roche’s Monday announcement had been a long time in the making.

“With the successful development of an antibody test with especially high specificity and selectivity, the investment Roche made in Penzberg over the last several years is paying off,” Kemper explains. “It also shows that the medical research landscape in Germany is capable of coming up with quick solutions in crisis cases.”

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