Genetic testing is vast of medical test which can identify changes in genes, chromosomes and proteins which helps determine an individual chance of getting a genetic disorder. There are many tests available to determine many common genetic diseases. Some methods of genetic testing are molecular genetic tests and biochemical genetic tests. Molecular genetic tests can determine a disorder by discovering single genes or short lengths of DNA to see the mutations or variation of that gene. Biochemical genetic tests look at the amount of movement from a protein and discovers the changes to the DNA for the result of the genetic disorder. .
Moreover, genetic tests are regulated by several agencies within the federal government such as the Center of Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). The FDA regulates the test kits that are a part of genetic testing. According to Genetic Alliance, the FDA oversees "the devices accuracy clinical sensitivity and specificity" which is under the Federal Food, Drug and Cosmetic act (Genetic Alliance). On the other hand, the CDC has a regulation called Clinical Laboratory Improvement Amendments of 1988 or CLIA. CLIA has strict requirements that "requires that laboratories meet certain standards related to personnel qualifications, quality control procedures and proficiency testing programs to receive CLIA certification" (Genetic Alliance, 2015). In contrast, some may feel the government is not exactly involved in the regulations of genetic testing. The FDA may oversees the tests but are not involved in the validity of the genetic test and the quality of the work. .
Types of Genetic Screening.
Genetic screening is a type of public health program that identifies risk for asymptomatic individuals to help prevention, early treatment and reproductive options (Andermann, 2010). Genetic screening involves more than just testing an individual but involving the focus on education and counseling.
