Company behind new FDA-approved coronavirus antibody aims to produce millions of kits by June

Tim O'Donnell

The Food and Drug Administration continues to expedite its approval time for technology that should help combat the coronavirus pandemic.

This time, the FDA cleared a coronavirus antibody test produced by Swiss diagnostics giant Roche for emergency use, the company said Sunday. The test identifies via blood samples antibodies made by the body to fight off the coronavirus. It could therefore determine whether a person had been infected with the virus in the past, even if the infection subsided.

There are questions about the accuracy of many available commercial antibody tests so far, but they're considered crucial for better understanding both the true extent of the pandemic, as well as possible length of immunity to the virus. Roche, at least, doesn't have those concerns about its product, saying its test has proven 100 percent accurate at detecting antibodies in the blood and 99.8 percent accurate at ruling out the presence of those antibodies. Thom Schinecker, who leads the company's diagnostics business, said they were able to run its test on 6,000 blood samples, which is a much higher number than its smaller competitors.

Additionally, Roche's infrastructure will allow it to increase production of the test quickly, and its kits are also designed to run on Roche automated machines, which are already installed in more than 100 labs throughout the U.S. The company is determined to dispense test kits in the "high double-digit millions" by June, and double that by the end of the year. Read more at The Wall Street Journal and The Guardian.

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