Gartner can't market onko-sure without FDA clearance.
Anyone who thinks Gartner can market onko-sure without FDA clearance should do a little research into the FDA's complaints against companies selling DNA testing without FDA clearance.
Those 23 states might allow the sale of onko-sure without a prescription, but the FDA won't allow it. onko-sure is not cleared by the FDA for use as a screener and that kind of clearance would take a PMA, not a 510(k). We all know what a PMA costs and how long it takes.
The video/presentation is a sales pitch. Gartner does not have the money yet so he won't be selling anything on August 1st unless someone gives him $1.5 million.
Gartner has no current licensing agreement with Radient.
Those are the facts.
I found it interesting that Gartner says in his video "x-rays can't detect level 1 and level 2 lung cancer." If a patient gets a positive result from onko-sure, the doctor does not know where in the body to start looking for cancer. If it's level 1 or level 2 LC, and the doctor does chest x-rays, Gartner says the x-rays will be negative. What will the doctor do next, knowing that the test has 95% specificity, meaning that in 5% of the onko-sure positive cases, they could look forever for cancer in the entire body and not find it, because it's not there?
Does the doctor prescribe chemo? We all know someone who has done chemo. That's no fun.
Does the doctor bathe the patient in radiation? of course not.
This is why I think onko-sure will never be cleared by the FDA as a screener, why onko-sure was not accepted and used by the global medical community, and why SRL had to sell their remaining tests for half price.
AI
