The field of personalized medicine is filled with many players, each with its own approach. Physicians considering the Navigenics genetic health service often ask me if we follow best practice guidelines set forth by leading professional societies. My answer is a clear “Yes.”
Leading medical genetics societies, such as the American College of Medical Genetics, the American Society of Human Genetics, and the National Society of Genetic Counselors, have laid out clear standards for the field of personal genetic services. These industry leaders usually describe our field as “direct-to-consumer” genetics, meaning that individuals may access these services themselves, rather than being required to seek a test through their doctor. And these groups want to make sure individuals who turn to these services receive high-quality care.
Navigenics values these standards as well. As part of our focus on quality,we meet criteria laid out by the major societies, including:
- Consumer-friendly informational materials
- Adherence to the testing policies and guidelines of professional organizations
- Use of a genetic analysis laboratory certified under the Clinical Laboratory Improvement Amendments, or CLIA
- An informed consent process
- Transparency in regards to the scientific evidence behind our service and any claims we make
- Disclosure of the risks, benefits, limitations, validity, and accuracy inherent in our service
- Patient and physician access to genetic professionals, such Genetic Counselors
- Privacy protection and compliance with the Health Insurance Portability and Accountability Act (HIPAA)
- Understandable results with clinical implications and follow-up
- Disclosure of clinical evidence behind recommendations related to test results
- Encouragement of consumers to share medically relevant information with their healthcare providers and work with them on a wellness plan, as we realize we are only a starting point in the process
We are also working with regulating agencies and others in the field to help set a strong set of blue-ribbon standards for personal genetic services. We are affiliated with several major academic medical centers of excellence, and must hold ourselves to a high standard of excellence, integrity and professionalism.
If you are a physician or clinician with any questions or comments on how Navigenics follows best practice guidelines,