Home » today » Business » FDA approval for Roche antibody test on COVID-19 share increases 04.05.20

FDA approval for Roche antibody test on COVID-19 share increases 04.05.20

The pharmaceutical company Roche can launch a test for antibodies against the novel coronavirus.

“This is now operational,” said Christoph Franz, Chairman of the Board of Directors of Roche, on Monday morning in Gabor Steingart’s “The Morning Briefing”. Roche says it has received FDA emergency approval for the test. According to a spokesman, this is valid for all countries that accept the CE marking for products. That includes all countries within the European Union.

“This is not a test for home use,” said the spokesman. It is a blood test that requires technical equipment to evaluate it. How the test could be rolled out in Germany is, among other things, a matter for the federal government. Federal Minister of Health Jens Spahn (CDU) and Bavaria’s Prime Minister Markus Söder (CSU) wanted to find out in the morning with Franz in the Roche development laboratory in Penzberg, Upper Bavaria, about the new serological test Elecsys Anti-Sars-CoV-2.

“It is much more sensitive and specific than the tests that are available today,” Franz said in an interview. The test had a sensitivity of 100 percent and a specificity of 99.8 percent. The former indicates the percentage of those affected by whom the infection is actually recognized. The latter says how many healthy people are actually recognized as healthy by the test.

It is a matter of measuring broadly in the population and giving a clear signal to individual people, said Franz. “Then everyone knows where he is.” Roche can therefore offer tests in the high double-digit million numbers per month worldwide. Because antibody tests are comparatively cheap, states can also afford them, said Franz.

The Roche share gains 0.45 percent in Swiss trading to CHF 336.95 despite a weak environment.

PENZBERG (dpa-AFX)

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