Regulation of Genetic Testing & FDA Oversight
January 11, 2013•9 min
With the explosion of genetic testing in the United States, the question is: At what point during patient care is it appropriate to use a particular genetic test for a particular patient?’Dr. Diane Allingham-Hawkins, PhD, Director of the Genetic Test Evaluation Program for Hayes, Inc. discusses the explosion of genetic testing in the United States, stating that “Our payer clients need an objective tool they can use to determine when and if a certain genetic or genomic test is necessary and medically appropriate. In patient populations for which multiple genetic or genomic tests might be considered, our interactive decision trees enable payers to answer the question, ‘’At what point in the continuum of care is it appropriate to use this particular genetic test for this particular patient?