Roche wins antibody test approval from FDA, will ramp up production to 100M a month

In a statement Swiss drugmaker Roche stated, it has an emergency approval for an antibody test to check whether people have ever been infected with the coronavirus, from the U.S. Food and Drug Administration (FDA).

The company is aiming to ramp up production by more than 100% for testing kits from the current 50 million a month to more than 100 million a month by the end of this year.

Individuals, businesses and governments need blood tests to determine who may be carrying the disease, and who may have some form of immunity towards it so that they can strategize and create a roadmap for ending national lockdowns.

Basel-based Roche, which also makes molecular tests to identify active COVID-19 infections, stated, its antibody test has a specificity rate exceeding 99.8% and sensitivity of 100%, which means that it tests will throw up very few false positives and no false negatives.

Its test relies on intravenous blood draws, said Roche, which provide higher accuracy in comparison to finger-prick tests.

“If you take blood from a finger prick, you will never be able to achieve the same level of specificity that you will achieve … when you take blood from the vein,” said Schinecker. “You have to have very, very high specificity. Even 0.1% or 0.2% makes a difference.”

Although Roche did not disclose the price for its test, it said it would be identical across the globe.

Schinecker foresees a high need for testing healthcare workers and their families for exposure, and those who showed signs and symptoms, to see if they have antibodies.

While antibodies typically imply some immunity, Schinecker acknowledged that much remains to be learned about the novel coronavirus before drawing definitive conclusions.

“Since this virus is not well known, one can hypothesize, but the proof will take longer,” said Schinecker. “Testing these people … is key to seeing whether or not people really have developed immunity.”

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