By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies
The Air Force Medical Service (AFMS) in partnership with the Coriell Institute for Medical Research (Camden, N.J.) have launched phase II of the longitudinal Clinical Utility Study (CUS). CUS evaluates the effects of returning personalized genomic risk information to Air Force personnel by examining changes in participants’ lifestyle and health-related behavior, changes in medical management, and long-term health outcomes.
In phase II, participation eligibility has expanded to include all Active Duty members and their spouses, as well as Air Force retirees and their spouses. Additionally, online enrollment is now available.
"Since 2010, when the study began, more than 2,000 AFMS personnel have volunteered to become part of the Air Force CUS cohort of the Coriell Personalized Medicine Collaborative," said Maj. (Dr.) Ruth Brenner, chief of AFMS Personalized Medicine, Air Force Medical Support Agency, in a statement. "This broadening of the cohort will enable researchers to examine areas of interest as approved by Air Force leadership, including cardiovascular health and obesity."
Study participants submit a saliva sample for DNA analysis and complete questionnaires based on personal and family medical histories, demographic information, as well as social/environmental data tied to lifestyle and diet. DNA samples are tested in Coriell’s CLIA-certified Genotyping and Microarray Center using the Affymetrix 6.0 GeneChip and the DMET Plus drug metabolism platforms. Once the genomic testing is complete, individuals’ personalized results are available for them to access directly through an online portal. Out of the 2,100 participants, about 1,300 have activated their accounts. Personalized reports are updated frequently and to date participants have received more than 28,000 personalized risk reports on common, complex diseases (i.e. type II diabetes, obesity, coronary artery disease, and melanoma) and drug metabolism (clopidogrel, warfarin and codeine).
Following the release of results, participants are queried at regular intervals to determine whether receipt of genomic information influenced their medical care, personal health decisions, and ultimately their overall health. In addition to the ongoing surveys, medical records are analyzed as part of outcomes evaluations to establish the potential benefit of genome-informed medicine.
"Subjects access their results through a secure online CUS website and are presented with both genomic risks and risks based on other factors such as diet, lifestyle and family history. These reports are not entered into the Air Force medical record and are only shared with the participant," Brenner added.
The study hopes to determine if reporting genetic variant risk related to complex disease and drug metabolism, directly to study participants, results in changes in long-term health and/or health behavior. Complimentary genetic counseling services are available for study participants and medical providers with whom they share their risk reports.