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The U.S. Food and Drug Administration issued Emergency Use Authorization to Illinois-based medical device maker Abbott Labs on Friday for a coronavirus test that delivers positive results in as little as five minutes and negative results in 13 minutes, the company said.
The company expects the tests to be available next week and expects to ramp up manufacturing to deliver 50,000 tests per day.
"I am pleased that the FDA authorized Abbott's point-of-care test yesterday. This is big news and will help get more of these tests out in the field rapidly," FDA Commissioner Steve Hahn said in a statement. "We know how important it is to get point-of-care tests out in the field quickly. These tests that can give results quickly can be a game changer in diagnosing COVID-19."
Scott Gottlieb, former FDA commissioner, echoed Hahn's comments on Twitter, calling the development a "game changer." Gottlieb also said it's "very likely" that we'll see additional approvals of point-of-care diagnostics behind this one, extending testing to doctor offices across the U.S.
(Score: 5, Informative) by Anonymous Coward on Monday March 30 2020, @07:57AM (1 child)
The FDA bureaucracy is a big problem. So are bureaucrats at other levels. They're preventing medical supplies from getting to those who need them.
1) Former NBA star Stephon Marbury arranged to have 10 million N95 masks sent from a Chinese supplier to New York at $2.75 each, which is well below the $7.50 that other retailers are selling them for. Apparently there's been a breakdown in communication [nypost.com] that has been preventing the masks from being purchased. This doesn't directly involve the FDA, but is another case of bureaucratic failure. The article says that someone in the city or state government claimed there was sufficient personal protective equipment and wasn't interested in the deal, despite ample evidence otherwise.
2) The FDA finally allowed an Ohio company to sanitize 80,000 N95 masks daily for reuse after initially limiting them to 10,000 masks per day. Ohio's governor criticized the FDA and the state attorney general threatened to sue [politico.com] before the FDA finally backed down.
3) A large supply of KN95 masks could be imported from China. These masks currently lack FDA approval, but provide equivalent protection to N95 masks. Many other countries are using them for medical purposes. So far, the FDA has not approved KN95 masks to be imported and hospitals are reluctant to use them for fear of lawsuits [buzzfeednews.com]. Instead, hospital workers are reusing N95 masks that haven't been fully sanitized along with makeshift forms of protection that are inferior to N95 and KN95 masks.
Proponents of the FDA bureaucracy often cite the refusal to approve thalidomide as justification for why approvals are so slow. But this is a crisis situation, in which a standard approval process will be much too slow. We're also not talking about approving drugs for human consumption, but personal protective equipment. The equipment I've described is superior to what healthcare workers are being forced to make do with right now.
Oh, and corporate bureaucracy isn't much better. My sister works at a grocery store called Schnucks, which is in the St. Louis area. They won't allow their employees to wear gloves or masks, despite it being safer for both employees and customers. This is not an isolated situation, but I think it's important to name the companies that are failing their employees. Why is it that we're asking healthcare workers and service employees to put themselves at considerable risk of infection, but bureaucrats and corporate drones are standing in the way of reasonable measures that could protect them?
(Score: 2, Informative) by Anonymous Coward on Monday March 30 2020, @04:05PM
Netherlands recalls 600K masks from China [aa.com.tr]
Chinese company apologizes for supplying defective and inaccurate coronavirus testing kits to Spain [msn.com]