AAN’S CALL TO INCREASE CONSUMER PRIVACY PROTECTION AND EDUCATION CONCERNING LDT AND DTC GENETIC TESTING
Genetic testing is an important procedure to examine your DNA (deoxyribonucleic acid), an acid present in our chromosomes in the center of our cells which determines the particular structure and functions of every cell, in revealing if there are changes (mutations) in your genes that may cause disease or illnesses.
The call is associated to a number of concerns regarding consumer ease of access to genetic testing that includes test accuracy, consumer protections regarding the privacy of results, and the lack of nursing’s role in providing best practices, context and education.
Services available under genetic testing in analyzing human DNA, RNA, and protein, range from spotting gene variants linked to a specific disease to paternity testing.
On the said report, the academy urges the Centers for Medicaid (CMS) and the Food and Drug Administration (FDA) to work with entities that own and market LDT and DTC genetic tests and services about the precision of the data that is delivered to consumers.
Other recommendations are listed below:
- Premarket demo of test validity and accuracy, and coordination with the Federal Trade Commission (FTC) to guarantee that the advertisements precisely reveal the information that will be given to consumers;
- Clinical effectiveness of the test, accessible description of the test results, possible breach of privacy, and loss of secrecy;
- Alternative options for testing and how to access consultation with a qualified genetic counselor or other health-care specialists to help assist with interpretations and options;
- Disclosure of potential for increasing out-of-pocket expenses for recurrent testing and/or office visits, and/or interventions.
Erudite Nursing Institute supports the American Academy of Nursing’s call to regulate LDT and DTC with the number of increasing issues concerning consumer’s ease of access over the past few decades.
The institute is aimed to produce top performing nurses in providing best practice and education to their patients.
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