FDA Grants Emergency Authorization To Roche Antibody Tests

TOPLINE

Pharmaceutical and diagnostic company Roche said Sunday that its coronavirus antibody test was granted emergency authorization by the Food and Drug Administration, and that it can churn out over 100 million of the kits by the end of this year, as governments search for ways to safely reopen communities and let people go back to work.

KEY FACTS

An antibody test can detect whether a person has had the coronavirus, according to the Wall Street Journal, which experts hope will mean protection against the virus moving forward.

It’s unclear if⁠—or for how long⁠—antibodies can prevent repeated infections of COVID-19, according to the Centers for Disease Control and Prevention; the virus is new and scientists are still learning about it, the WSJ reported.

Roche says its test is 100% accurate in detecting the presence of antibodies, and 99.8% effective in ruling out the presence of antibodies, which means very few false positive results.

Roche’s test relies on an intravenous blood draw as opposed to a finger prick, Reuters reported.

According to the WSJ, most commercially-available antibody tests aren’t accurate enough.

Roche has already begun shipping its test to labs around the world, CNBC reported.

Crucial quote

“Testing these people….is key to seeing whether or not people really have developed immunity,” Thomas Shinecker, Roche’s head of diagnostics, told Reuters

Big number

6,000. That’s how many blood samples Roche tested for antibodies, Shinecker told the WSJ. Roche was able to test a significantly higher number of samples compared to its rivals, the WSJ said.

Key background

Antibody testing is seen by governments around the world as one key to reopening economies, as the results can provide insight into the spread of coronavirus⁠—especially mild or asymptomatic cases, the WSJ reported. Some governments are looking into whether to issue “immunity passports” to people who have antibodies, which could let those individuals return to work sooner. There is no vaccine or treatment for coronavirus (although antiviral remdesivir, also granted emergency FDA authorization over the weekend, appeared to shorten recovery time in a federal trial). 

Further reading

Coronavirus Vaccine In 12-18 Months Is ‘Ambitious’, Roche CEO Says (Forbes)

Coronavirus Drug Update: The Latest Info On Pharmaceutical Treatments And Vaccines (Forbes)

Coronavirus Business Tracker: How The Private Sector Is Fighting The COVID-19 Pandemic (Forbes)

Handicapping The Most Promising Of 267 Potential Coronavirus Cures (Forbes)

Gilead’s Antiviral Remdesivir Had A Good Day – But It’s Still Not Clear How Effective It Is Against COVID-19 (Forbes)

Full coverage and live updates on the Coronavirus

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