Their doctor should be qualified to make that judgment without a government bureaucracy evaluating the efficacy of the test on their behalf, unless you want to completely destroy the rate of medical breakthroughs. If there's no potential harm from the procedure itself, the government shouldn't be involved at all.
Imagine if every new AI model had to be "cleared" by a government regulator. The role of government in healthcare evaluation needs to be simplified and streamlined. The liability needs to be shifted to doctor, and if it's a case of charlatanism, that liability should include a lengthy prison sentence.