I don't know. A friend sent it to me this morning...all I know is he's at some fishing tourney this morning and he left around 4AM...so somewhere within two hours from here, I'd guess.
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Thread by @ASlavitt: BREAKING: Great news. SalivaDirect received approval this morning from the @US_FDA. This could be one the first major game changers in fight…
Thread by @ASlavitt: BREAKING: Great news. SalivaDirect received approval this morning from the @US_FDA. This could be one the first major gagers in fighting the pandemic. Rarely am I this enthusiastic. Here’s why. Follow if interested. 1. One reason? Sa…
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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.
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.
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).
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.
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...
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...
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).
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.
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.
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.
About SalivaDirectRegularly testing large numbers of people will play a huge role in monitoring transmission of SARS-CoV-2. Quickly detecting and isolating active cases - people who can transmit the virus, whether sym…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.
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.
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.
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.
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.
Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization to Yale School of Public Health for SalivaDirect, Which Uses a New Method of Saliva Sample ProcessingThe FDA issued an emergency use authorization to Yale School of Public Health for SalivaDirect, a COVID-19 diagnostic test, using a new method of processing salhttps://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.
Lol. Parents.
Some of them are just as invested as the kids. Look at parents like Bryce Young's that handled his recruitment, invested boat loads of money, and spent hours upon hours of hosting coaches, phone calls, texts, and trips. I'd say they want the best for their kids over some guy apparently not qualified to hold his position making decisions that affect their lives.
#fight. << why? Terrible hashtag.
Helicopter parent much? I do realize some of those parents are actually paying for their kids to attend and play, but damn that strikes me as being way too involved.
Quick google and it looks like the WHO made this statement in early June. Not sure if anything has changed but trying to see. I did see some what WHO meant articles after this.
UAB's Bill Clark ... "I was laughing at the myocarditis news because the SEC schools were already doing it and we were as well." Now, UAB is a bit different being a University with a Medical school. Still, the notion that the "myocarditis" narrative is/was being pushed so hard...
So where did that quote come from that you were referring to?
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