A plan to analyze the DNA of incoming students at the University of California, Berkeley and give them personalized results was recently scaled back amid concerns that such research amounts to a medical diagnosis -- a violation of state and federal laws.
The university has already sent more than 5,000 genetic testing kits to incoming students for the voluntary, anonymous program, which involves testing three common gene variants that would "reveal aspects of how an individual metabolizes milk, alcohol and vitamin B9 [folic acid]." About 600 students consented to the test and provided their saliva samples, according to the university, which contests the state's position that the program violates any statutes.
"The change to UC Berkeley's program was necessitated because the California Department of Public Health [CDPH] insisted that since students would have been given access to their own test results, the academic exercise was not exempt from laws designed to assure the accuracy and quality of diagnostic tests used in providing medical care to patients," a university press release stated.
In a statement from CDPH Policy and Programs Chief Deputy Director Kevin Reilly, he contends that human medical tests must be performed in licensed laboratories if the results are to be released to the person. A UC Berkeley campus laboratory that routinely conducts genotyping was chosen to perform the DNA tests, which is exempt from such rules under California law, the university claims.
The CDPH disagrees. "Research laboratories that do research testing only and do not report individual results are exempted from this license requirement," Reilly said in the prepared statement.
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