It’s taken far too long and it’s still not FDA approved for at-home use or for asymptomatic individuals but the new $5,15-minute, easy to use, Abbott test and the Trump administration’s promise to purchase 150 million of them is a big deal. Abbott has been building capacity for months according to their lead scientist interviewed in the Atlantic by Alex Madrigal and in a few weeks will be producing 50 million tests a month:
Madrigal: Fifty million tests a month is a huge number. That’s more than twice the number of tests the U.S. completes in a month. How did you ramp up production so massively?
Hackett: This was the challenge of this program. We needed some sort of reliable testing that could be affordable and that doesn’t require instrumentation. You need scale. The more frequently you could test people, frankly, even tests with lower sensitivity would be very effective at identifying people quickly and slowing the spread. As we were developing the test, there were people working in parallel looking at supply chain and logistics. Abbott took a lot of risk—hundreds of millions of dollars were spent building two new manufacturing facilities focused solely on those tests. We hoped we could come to a solution that would be where we needed it from an overall accuracy perspective, but if you weren’t building capability simultaneously, there was no way it could be the answer.
The US has performed about 80 million tests since the pandemic began, so an additional 50 million tests a month is a big increase in capacity. As noted, the test is not approved for at-home use but it’s a CLIA-waived test which means that a doctor’s office, a CVS or Walmart clinic, even a school nurse could qualify for a waiver and perform the tests. The test is not approved for asymptomatic individuals but I suspect that won’t mean much in practice, it can be prescribed off-label although the fact that a prescription is required is limiting. I hope the necessity for a prescription will be lifted as we get more experience with these tests. False positives (~1.5%) are low and by taking the strain off the PCR system we can improve triage and afford to do more double checks. False positives will be more of an issue as we wipe out the virus but that will take time.
I hope these tests will open up air travel within a month or two. I also hope to see more of these types of tests approved. Derek Lowe has more technical details.
It won’t be all smooth sailing, Abbott may not be able to produce as much or as quickly as they say they can and quality in the field may fall. The government may distribute the tests poorly. The virus could pickup in the fall, as in 1918. I expect more problems and challenges but we now have a chance to get ahead of the virus which is very welcome news.
Addendum: This type of public-private partnership with private firms building capacity in advance of approval for tests and vaccines on the foundation of government push and pull funding is exactly the structure that the Accelerating Health Technologies team has been recommending both to the US government and to governments around the world.