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BREAKING: Great news.
SalivaDirect received approval this morning from the @US_FDA.
This could be one the first major game changers in fighting the pandemic. Rarely am I this enthusiastic. Here’s why.
Follow if interested.
SalivaDirect received approval this morning from the @US_FDA.
This could be one the first major game changers in fighting the pandemic. Rarely am I this enthusiastic. Here’s why.
Follow if interested.
1. One reason? Saliva.
We already have it. We don’t need to export it from Italy or run out. We don’t need to stick something 4 inches up a kid’s nostril.
But that’s just the start.
We already have it. We don’t need to export it from Italy or run out. We don’t need to stick something 4 inches up a kid’s nostril.
But that’s just the start.
2. The second reason is profit. Or lack thereof.
SalivaDirect is a protocol of how to do tests with whatever equipment you have as long as it gets approved by Yale (who developed the protocol).
SalivaDirect is a protocol of how to do tests with whatever equipment you have as long as it gets approved by Yale (who developed the protocol).
They decided not to sell a specialized kit (so they didn’t have anyone run out).
They are turning testing from a bespoke suit to a low cost commodity. I’ve been writing about this goal for months.
They are turning testing from a bespoke suit to a low cost commodity. I’ve been writing about this goal for months.
The cost of the materials are about $4. This test should be very cheap even if you add labor and overhead. Not the $100 for current tests.
This is important for the next reason— so important...
This is important for the next reason— so important...
3. The most important reason is because the most important testing feature is CADENCE. How frequently can we test people.
At a $10 test, you can test every day or every couple days. This is even more important than accuracy. But on accuracy...
At a $10 test, you can test every day or every couple days. This is even more important than accuracy. But on accuracy...
4. Official data shows 88-94%. If you assume 90% sensitivity, this is the best accuracy (sensitivity) of any saliva test.
(It also means if you took it twice, for $20, you would have 99% accuracy).
(It also means if you took it twice, for $20, you would have 99% accuracy).
5. This is important because of schools. Universities. Office buildings. For wide testing of asymptomatic people.
They are all getting introduced to the test in the next few weeks.
You can’t spend $100 multiple times/week on a person’s point in time test.
They are all getting introduced to the test in the next few weeks.
You can’t spend $100 multiple times/week on a person’s point in time test.
6. Turnaround time. SalivaDirect can be pooled for faster turnaround.
In addition, labs around the country will be authorized to be able to do the test if they show they have the basic equipment.
In addition, labs around the country will be authorized to be able to do the test if they show they have the basic equipment.
7. For all of these reasons Saliva Direct should create millions more in test capacity. Easy to use. High volume. Cheap. Widely available and accurate. https://covidtrackerct.com/about-salivadirect/
Do I sound like I’m advertising? You couldn’t be blamed for asking who is making money at this. Or who could. Or how could it get screwed up.
Because the pandemic is nothing but a profit making effort for many.
Because the pandemic is nothing but a profit making effort for many.
The people who created this test— a special alliance of folks who came together. Run by @YaleEMD and the @NBA with leadership by @robbysikka.
Not only are they not making money, they invested money, time & resources. They are making $0.
Not only are they not making money, they invested money, time & resources. They are making $0.
Let me say again $0. And they are committed to always making $0.
What’s the catch?
Does that mean others won’t try to make money at this test? No.
You could imagine somebody getting approved for a test that cost $4 and trying to charge $100.
Does that mean others won’t try to make money at this test? No.
You could imagine somebody getting approved for a test that cost $4 and trying to charge $100.
How we prevent that is our next challenge?
Public pressure and awareness is a part of this. This should be a kick off to a lot of new lower cost high quality tests.
And some testing companies aren’t going to like this.
Public pressure and awareness is a part of this. This should be a kick off to a lot of new lower cost high quality tests.
And some testing companies aren’t going to like this.
Side note: if this were any other country but the US, this wouldn’t be a worry.
It’s a perfect turn of the road to see if profits or our country are more important.
If you want access to implement in a lab, here is how. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-emergency-use-authorization-yale-school-public-health
When can you get? I expect it to be a short time before labs start coming online. Will keep you posted.
Congratulations and great thanks to patriots:
@NathanGrubaugh
@awyllie13
@VogelsChantal
@robbysikka
Very proud to know you all. /end
@NathanGrubaugh
@awyllie13
@VogelsChantal
@robbysikka
Very proud to know you all. /end
If you want more context, here is our comprehensive national testing strategy and how Saliva Direct fits in. https://coronavirus.medium.com/why-testing-improvements-are-so-critical-c2713f925861
In May, when the White House task force ended, I was calling for very close to what Saliva Direct is doing.
We need to make tests commodities. See how. https://coronavirus.medium.com/heres-how-the-us-can-start-testing-more-people-for-covid-19-ed3f10bb9952
We need to make tests commodities. See how. https://coronavirus.medium.com/heres-how-the-us-can-start-testing-more-people-for-covid-19-ed3f10bb9952
Here is a background story on the development of the test. https://www.espn.com/nba/story/_/id/29667299/fda-allowing-saliva-based-test-funded-nba
Here more great stories like this: http://smarturl.it/inthebubble .
To discuss the NBA test, protocol & more, subscribe now to hear @SteveKerr on #inthebubble podcast dropping Wednesday.
More on sports starting with @AdamSchefter and @mcuban.
More on the science of the virus with @larrybrilliant & on vaccines.
http://Smarturl.it/inthebubble
More on sports starting with @AdamSchefter and @mcuban.
More on the science of the virus with @larrybrilliant & on vaccines.
http://Smarturl.it/inthebubble
