Get Prometheus Genetic Testing

Genetic counseling and informed consent is recommended prior to all genetic testing and is required prior to predictive testing.

insurance Portability and Accountability Act (HIPAA) doesn't include genetic information. The federal laws that deal with genetic information are GINA (the Genetic Information Nondiscrimination Act of 2008) and, more recently, HIPAA. GINA is essentially an anti-discrimination law that has nothing to do with privacy.

Part of the FDA's mission is to protect public health by ensuring the safety, efficacy, and security of drugs, biological products, and medical devices. The agency considers genetic tests to be a special type of medical device, and therefore these diagnostic tools fall within FDA's regulatory purview.

Results: The most highly ranked concepts included: (1) genetic testing is voluntary; (2) why is the test recommended and what does it test for?; (3) what results will be returned and to whom?; (4) are there other types of potential results, and what choices exist?; (5) how will the prognosis and management be impacted ...

Informed consent for genetic testing is generally obtained by a doctor or genetic counselor during an office visit. The health care provider will discuss the test and answer any questions. If the person wishes to have the test, he or she will then usually read and sign a consent form.

Listen to pronunciation. (in-FORMD kun-SENT) A process of information exchange between a clinician and an individual or their legal proxy designed to facilitate autonomous, informed decision making.

Since sequencing a person's genome can have implications for identity and privacy, the informed consent process is an important touchstone to maintain research participant autonomy. This page contains information about informed consent, with a particular focus on considerations that are specific to genomics research.

Test sent to Prometheus Labs. Please be advised that the fee for the Anser IFX test is $2,500.00 and the CPT code 84999 (unlisted chemistry procedure) is not covered by many insurance carriers. It is recommended that prior authorization is obtained before ordering this test.