Considerations for designing a prototype genetic test for use in translational research

Area of Science:

• Genetics
• Public Health
• Translational Research

Background:

• Translational research requires returning personal genetic susceptibility information to participants.
• A standardized method is lacking for selecting genetic variants for such research.
• This gap hinders rigorous studies on genetic information's impact on common health conditions.

Purpose of the Study:

• To design a process for identifying gene variants and health conditions for a prototype genetic test.
• To facilitate research involving the return of individual genetic test results to participants.
• To support the Multiplex Initiative, a larger research effort.

Main Methods:

• Developed inclusion criteria through a transdisciplinary and iterative process.
• Considered evidential support for genetic associations with common health conditions.
• Evaluated appropriateness for human subjects research and incorporated expert peer reviewer recommendations.

Main Results:

• A process was designed to identify gene variants for translational research purposes.
• The process facilitates the creation of prototype genetic tests for returning results.
• Inclusion criteria were established based on scientific evidence and expert review.

Conclusions:

• The developed selection process is for translational research, not clinical testing.
• This process can guide researchers in designing studies on genetic susceptibility testing.
• Such research is crucial for translating genomic discoveries into public health benefits.