USA Today reports that the Food and Drug Administration has approved Abbott’s 5-minute COVID-19 test:
CHICAGO – A five-minute, point-of-care coronavirus test could be coming to urgent care clinics next week, and experts say it could be “game-changing.”
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.
Physically the tests are small cartridges that are used by Abbott’s ID NOW benchtop instrument. There are presently 18,000 of these units installed around the country. I suspect we can expect Abbott to start producing more of them.
Also, USA Today reports that the limitations the FDA had imposed on Battelle’s using its facemask sterilization process have been lifted:
COLUMBUS, Ohio – After a day of pressure from Ohio Gov. Mike DeWine, the U.S. Food and Drug Administration late Sunday rewrote rules to allow full application of a potentially game-changing Battelle technology to sterilize protective masks worn by those treating coronavirus victims.
The agency ruled that upgrading its emergency use authorization from partial to full “is appropriate to protect the public health or safety.”
DeWine said Sunday night that he and Lt. Gov. Jon Husted “just had a very productive call” with the Food and Drug Administration. “I anticipate a positive announcement soon. We must do all we can to protect our front-line workers.”
Husted tweeted: “This Ohio-driven solution has the potential to save lives now and in the future across the United States.”
I suspect these are just two of many new tests and processes that will be deployed in the coming days. 50,000 tests a week and 80,000 masks sterilized per day are fractions of the need but these are steps in the right direction. They won’t be the last.
And yet another small step. The Hill reports that the FDA has issued an emergency use authorization for the use of hydroxychloroquine (HC) and chloroquine in treating COVID-19:
The Food and Drug Administration (FDA) on Sunday issued an emergency-use authorization for a pair of anti-malaria drugs as health officials work to combat the rapid spread of the novel coronavirus.
The Department of Health and Human Services (HHS) said in a statement that the authorization would allow 30 million doses of hydroxychloroquine sulfate and 1 million doses of chloroquine phosphate to be donated to the Strategic National Stockpile. The doses of hydroxychloroquine sulfate were donated by Sandoz, while the chloroquine phosphate was developed by Bayer Pharmaceuticals.
Hopefully, this move will motivate more physicians to start giving these drugs to their patients with COVID-19, possibly in combination with azithromycin, as was used in South Korea.
Use of HC will probably cause some problems, too. The drug is presently used to treat other diseases including rheumatoid arthritis and shortages will probably develop rapidly. We need to produce all of the pharmaceuticals domestically and some emergency grants for doing just that should be approved by the Congress.