GC wrote this:
“Regulatory changes at FDA have forced us to only be able to offer lesion-based PCR testing. As we conduct more research and work with the agency, we are hopeful to be able to submit an EUA for saliva-based PCR testing for MonkeyPox in the future.”
That language to me reads like, we submitted what we know we could get approved. I think it is probably likely that the FDA guided them somewhat and gave them the roadmap. I think we will see a yes from the FDA in a relatively quick timeline. For them. Maybe only a matter of weeks.
It does also read like GC was so frustrated by being told something like, don’t even try submitting the saliva test for consideration.
A denial would slam the SP down really hard. So he went with the lesion test for the easy win. Which I think was the right move. Get it approved and out there.
I am totally guessing when I say effective lesion testing could lead to saliva testing. If I were a doctor. And I had the test. Maybe in the San Francisco area. I would try it via saliva in an outbreak region. I can’t see any negative impact. Swab the mouth with a cotton swab and stick it in the vial. See if you start getting positive results weeks ahead of visible symptoms. It isn’t administering a drug. Which could have risks to health and life. So ethically, morally, legally, I don’t see a huge risk on their part.
But my medical degree, much to my Mother’s disappointment, is not going to happen in this life. So I could be full of you know what!
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