If GCDx tries to market the LC Screener online, the FDA will shut them down the same way they shut down the companies selling DNA tests online, IMO.
But I don't think it matters anyway -- even if Gartner sold the LC screener online, I am quite sure that revenues would be dismal.
Doctors won't prescribe it or support it. Insurance companies won't reimburse for it. If you walk into a doctors office and say "my LC screener test says I have lung cancer, but I have no symptoms," the doctor will give you a chest X-ray.... but Gartner claims a chest X-ray won't detect the early stages of lung cancer, so what have you accomplished?
Then the doctor will research onko-sure and try to convince you that the test was a waste of money.