The Coriell Personalized Medicine Collaborative has launched a longitudinal genomics study in which researchers will provide genetic testing to 2,000 active duty healthcare providers serving in the US Air Force Medical Service to gauge their susceptibility for a variety of diseases and characterize their response to various drugs.
The research effort is part of the longitudinal Air Force Patient-Centered Precision Care Research, or PC2-Z program, under which the Air Force is hoping to familiarize medical personnel with genomic risk information and evaluate how best to use genomics information to more efficiently deliver healthcare and incur savings. Coriell began recruiting people for the study in January, and has so far enrolled 436 people who have been genotyped and received the first set of test reports.
"The Air Force as part of their PC2 program is very interested in not only evaluating the utility of personalized medicine but making sure that physicians are well equipped to execute [individualized care] in the future," Erynn Gordon, Coriell's director of genetic counseling, told PGx Reporter.
Additionally, the military healthcare service, similar to payors in the civilian world, is interested in lowering costs by cutting unnecessary spending and reducing adverse reactions. For example, the Air Force "recognizes that it wastes millions of dollars each year on [the antiplatelet drug] Plavix," said Coriell CEO Michael Christman.
According to a recent estimate by the Congressional Budget Office, the Defense Department’s annual healthcare spending could grow from $51 billion in fiscal 2013 to $90 billion by 2030. By the CBO's calculations, the DoD will go from spending 9 percent of its 2013 budget on healthcare to spending 14 percent by 2030.
This collaboration is an offshoot of a project that Coriell launched in December 2007 for the lay public with the aim of studying the impact of genome-informed treatment on medical care. The study, which has so far enrolled thousands of participants, has research partnerships with Cooper University Hospital, Virtua Health, Fox Chase Cancer Center, Helix Health, and others, and plans to ultimately enroll 100,000 participants (PGx Reporter 6/17/2009).
For its effort with the Air Force, however, Coriell will only report to the military deidentified data so it can track healthcare utilization and assess where genetic testing is improving health outcomes. Genetic testing information can be included in study participants' electronic medical records only if they choose to share this information with their doctors.
"The intent of the study is to keep the Air Force health service on the cutting edge of providing care," Christman said. "It's not about trying to use genetics to predict fitness for duty or anything like that."
The Genetic Information Non-Discrimination Act prohibits employers and health insurers from making coverage or employment decisions solely based on a person's genetic predisposition for a disease. However, GINA doesn't apply to military personnel.
Depending on how many people choose to share their genetic information with their healthcare providers, the study could eventually test the idea that genetic testing is most efficiently integrated into medical care if it is done in a multiplex fashion, before it is needed in clinical care, and if the test results are already available in the patients' medical records.
"People tend to be in this health system for life. So, the records go back many years, and so there will be a lot of valuable clinical data that makes its way into this particular cohort," Christman noted. This project "gives us the chance to have a lot of new data to mine but also because of the availability of EMRs, it gives us a chance to think about how to incorporate this information into such a system.
"The idea is that this will truly be a longitudinal study and will go on for years and years in order to follow health outcomes using genomic information," Christman said. Coriell has just gotten the first set of survey responses from study participants and could not say how many people had so far agreed to share their information with their doctors. For the time being, Coriell researchers will use study participants' answers from outcomes surveys and collect data from their medical records over time to evaluate the utility of the risk results.
In the program, researchers are using Affymetrix's Genome-Wide Human SNP Array 6.0, which analyzes 906,600 SNPs and a similar number of copy number probes. The researchers are also using the DMET Plus Array, which gauges 1,936 markers in 231 genes associated with drug metabolism. The Johns Hopkins University Applied Physics Laboratory is providing technical oversight and managing the program in collaboration with Coriell and the Air Force.
Following testing, study participants will learn about their susceptibility for 24 diseases, including a variety of cancers, coronary artery disease, asthma, and rheumatoid arthritis. They will also learn whether they harbor gene variations associated with response to Plavix, the anticoagulant warfarin, the analgesic codeine, proton-pump inhibitors for gastric acid reduction, and thiopurines for the treatment of autoimmune disorders and acute lymphoblastic leukemia.
Coriell's external advisory board chooses which gene associations to pick based on the strength of evidence in published literature and if there is some action people can take to mitigate their risk for certain diseases. Over time, the board will approve additional potentially actionable conditions and gene-drug pairs that can be reported to the study participants. Currently, Coriell reports between one to two new results each month.
Study investigators are recruiting participants in person at Air Force bases and online. Researchers have hosted informed consent sessions and collected saliva samples at recruitment efforts at Travis Air Force base in California, Wright-Patterson Air Force base in Ohio, and other locations.
According to Christman, Coriell would eventually like to expand its enrollment efforts to the entire Air Force personnel, but initially the researchers are focusing on active duty medical personnel in an effort to "teach the teachers." Coriell is hoping that by helping the Air Force medical personnel understand their own genetic risk information, they in turn will be able to discuss this type of data with patients they interact with in the future.
"By personally engaging the Air Force medical service they'll gain a familiarity with genomic information and in the long run will be better poised to incorporate genomic information into the care of their patients," said Gordon.