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WASHINGTON – Medical treatment will become more genetically specific to individuals as the 21st century progresses, the Mayo Clinic's director of laboratory medicine told a congressional subcommittee Wednesday.
Dr. Frank Cockerill said that Mayo, one of the world's leaders in specialized diagnostics, develops 150 tests per year in an attempt to become more precise in treating patients.
The Rochester-based clinic is moving toward tests that will let doctors tailor treatments that are unique to individuals, Cockerill told participants at a 21st Century Cures roundtable sponsored by the House Energy and Commerce Committee's subcommittee on health.
For instance, instead of using standard dosages, Cockerill said Mayo's labs try to transform scientific discoveries into "valid tests" that allow doctors to apply "specific genetic findings in a patient."
Precision was an overarching theme of the roundtable, attended by officials from academic institutions, regulatory agencies and the device and drug industries. The cost of sequencing a human genome has gone from $300 million in 2001 to $1,000 in 2014, according to the Personalized Medicine Coalition, which includes academic, industrial, financial, patient and provider groups.
"Patients want and need new effective tests," Louis DeGennaro of the Leukemia and Lymphoma Society told the roundtable. Leukemia treatment offers a model for how science can turn a once-fatal disease into a chronic condition that can be managed, he said.
Treatment based on an individual's genetics is the future of medicine, Cockerill said in an interview with the Star Tribune. But gathering data may not be as difficult as figuring out how to pay for it and use it.
Laboratory research funding has been cut, Cockerill told the subcommittee. Similar but separate federal and state approval processes for lab tests are not just time-consuming, they are very costly.
A larger problem comes in making genomic therapies mainstream and affordable.
As Dr. Patrick O'Gara of the American College of Cardiology noted, "The average clinician is light years removed from the application of this technology."
That makes the role of genetic counselors invaluable in 21st century cures, Cockerill said.
Who will pay?
Education will have to extend not just to patients and providers, but also to third-party payers, he added. Health insurance companies and such government programs as Medicare and Medicaid often do not reimburse for cutting-edge treatments. Most patients, meanwhile, cannot afford those treatments out-of-pocket.
Cockerill favors government and private programs that allow at least partial third-party payments for limited amounts of time to determine the widespread effectiveness of the most promising genomic breakthroughs. This, he said, is a way to "push innovation and access to patients."
He also believes doctors' ability to apply established lab tests to new diseases provides a road "to move science forward in a safe way."
Finally, though, the ability to understand a person's genetic makeup comes with a moral quandary. How much people want to know about their medical futures is a matter of individual choice. There are cases of women having preventive mastectomies because they have a genetic predilection to breast cancer. There is speculation that health insurance companies would deny coverage to people if they found out about certain genetic dispositions.
Cockerill himself doesn't want to know if he is genetically coded to get an incurable terminal disease. "For diseases that you can do something about, people want that," he said.
The problem is that once a person's genes have been sequenced, all of the genetic news is out there, good or bad.
"If you do the whole genome, you have to have the informed consent of patients," Cockerill said. And "if you do the entire genome, you have to protect access to that data."