However, once a test is beyond the research state, informed consent is not legally required. The FDA must give permission before a manufacturer can market a drug, kit, or device to physicians or the public. I thought the test was still in the research stage. A clinical laboratory may offer tests as a service without FDA approval, but may charge only enough to recover its cost. Unless a test is experimental, informed consent is not legally required.
Some physicians use it anyway, especially for invasive tests such as amniocentesis.
Some other states allow parents to refuse testing on religious grounds. This may be used when there is minimal risk. Genetic testing differs from other kinds of testing because it may provide information about other blood relatives. It may also predict some aspects of future health, years in advance. Therefore, some have argued in favor of special informed consent forms that would present risks to privacy, insurance, or employment.