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.â€
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.â€
Husted tweeted: “This Ohio-driven solution has the potential to save lives now and in the future across the United States.â€
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.
Update
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.
Every day small but important steps are taken to either improve or facilitate the federal and state’s response to the CV. However, no matter what innovative or responsible measures are introduced, almost on a daily basis, the press only seems more emboldened to pepper the administration with petty questions, becoming annoying mouthpieces for petulant criticisms and misinformation.
I am so glad that his new test is on the way. It is still so galling knowing that most of our tests take 2-5 days to return while listening to a certain govt official telling us we have have the best testing system in the world.
Yes jan. I will do my best to not be petulant if one of my people die because we just couldn’t have testing available on par with the rest of the world. (OTOH it does make my job a bit easier. I personally call each of my staff to let them know if they have been exposed to a Covid positive pt who was asymptomatic when they worked with that pt. Every time this has happened so far it has taken at least 5 days to get the results. I get to tell my people since they are still alive and neither they nor their family have symptoms, they are probably OK.)
Steve
Steve:
1) My comments were directed at the press, not you.
2j There were lots of false positives and negatives in the testing done by other countries. IOW, accuracy has been one of the hurdles to overcome, as well as cutting many of the strict policy rules/regulations that were slowing up private sector testing approvals. Nevertheless, you continue railing against flaws intrinsically set in the prior administration’s CDC/FDA protocols, not giving a sliver of credit for all the starting-from-scratch efforts quickly embarked upon by the current task force. I think some of your sarcastic criticism is very off base. However, I commend you for all the work you’re doing, under the very grim circumstances this virus is putting medical personnel through.
Here is a question; can anyone develop a test for Abbottâ€s instrument — or is it restricted to Abbott only? Similarly, what about Roche, Thermo Fisher’s instrument? In software terms, are they open or closed platforms?
Then there is a further questions, did the South Koreans develop a test that works on an instrument widely available for clinical use in the US, or it requires a South Korean instrument, or does not require any instruments at all?
In a sense, I wonder if this needs to be looked at post-crisis – whether the medical instruments used in clinical diagnosis in this country are too inflexible in a crisis.
CO,
From what I read on South Korea’s testing, it took about 5-6hrs for them to get results back. This was likely helped in part to the fact they had over 90 labs up and running throughout the country ready to test samples, while we had the CDC and only a handful of labs.
“From what I read on South Korea’s testing, it took about 5-6hrs for them to get results back.”
Correct, but at least 3 weeks ago they added the quicker test. They have constantly been about a month ahead of us in testing despite our receiving the genomic info the same time they did. So jan wants to praise them for developing tests from scratch, and I am glad we finally are getting them, but I wish we had them a month ago. IIRC S Korea wasn’t the only country to develop tests faster. I think that we are almost unique in taking so long.
“a potentially game-changing Battelle technology to sterilize protective masks worn by those treating coronavirus victims.”
We face a dilemma. Do we go with the sterilization option developed and published for free by the U of Nebraska or do we go with the system that was approved via the political process? The former is also much cheaper and we already have it, but can only be used 5 times. The latter costs more, not sure how well tested but can, per advertising, be used 20 times per mask? We know that advertising claims are always correct, so do we bet the lives of our staff on that? (To be clear, people mostly worry about their families, not their own lives.)
Steve
BTW- Covid deaths in Sweden are accelerating. Same in Japan. Was there a third country being touted for their laissez faire approach?
https://twitter.com/ShyamNation/status/1244789861346729984
Steve
So why I am asking my questions –
If the equipment that is used or high throughput or low latency testing in the US restricts who can develop a test on them to the equipment maker — you are dependent on the equipment maker to develop tests to scale testing.
If the South Koreans developed a wonderful test but it requires equipment that is rare in the US, the US could not use it even if it imported South Korean tests.
Both are key in understanding why it took so long for anyone in the US outside the CDC to have a scalable testing regime.
It is worth pointing out – a plan that assumes the CDC always get test development on time is a bad one. R&D never works that way.
Any restrictions on who can develop tests is in general a bad policy.
I can see your point for the fast test. Not so much for initial testing. We were way behind there also and many countries were able to do testing way ahead of us. Plus I think it was fairly well documented that there was the odd choice of adding SARS and MERS to the first test attempt.
Steve
Both Nevada and Michigan have banned the use of hydroxychloroquine. Will they relent?
I guess it depends on your operative definition of “can”. ID NOW is Abbott’s proprietary product and protected by patent and copyright law. That’s where the wheel would hit the road. Abbott could license the technology to other companies or other companies could reverse engineer ID NOW. If either of those happens the commercial usefulness of the product is probably over.
My understanding is that Nevada and Michigan imposed restrictions on the out-patient usage of the drugs to avoid hoarding and unavailability. No restrictions I can find on inpatient use.
Steve
That’s what I surmised. Much of the diagnostic equipment in the US are closed platforms.
Look, I am displeased with what happened with the CDC. But any plan that requires the CDC to develop a test first (which was template from H1N1, Zika), before everyone else is more risky then one where we let multiple actors work on a test; as everyone has found out.
Just as restricting development of tests to the original equipment manufacturer is probably not a good idea for scaling clinical testing.