tagged w/ Genetic Tests
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Seminar on genetic testing for breast and/or ovarian cancers with an opportunity to enroll in a clinical study.Seminar on genetic testing for breast and/or ovarian cancers with an opportunity to... more
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In spite of recent legislation, tougher laws are needed to prevent insurers and employers from discriminating on the basis of genetic tests
By Mark A. Rothstein
KEY CONCEPTS
Genetic testing will expand quickly and soon, adding highly targeted data to people’s medical records. As those records go electronic, outsiders will find it increasingly easy to peruse an individual’s health information.
Able to uncover private details, health and life insurers could deny coverage to someone with a complex medical condition, and employers could fire or refuse to hire the person to avoid burdening the company health plan.
Existing laws offer weak protection at best; legislation is needed to give individuals more control over their own data, to limit unauthorized disclosures by others and to penalize wrongdoers.
In years gone by, if colon cancer ran in your family all you could do was wait and worry about whether you might get it, too. Today a genetic test can determine whether you have inherited a greater-than-average risk of the disease and so could benefit from preventive care. The more doctors know about your genes, the better able they are to prevent, treat or cure illnesses.
Excitement about such prospects surrounded the start of the Human Genome Project in 1990. But the enthusiasm was soon tempered by widespread concern about the need to protect the privacy of a person’s genetic information. Simple tests that could readily reveal an individual’s genetic endowment could also readily cause embarrassment or stigma. Furthermore, insurers could deny people health coverage or raise the premiums they have to pay. And employers seeing the results could deny people jobs or fire them. At the same time, scientists and public health officials recognized that the potential to improve health care based on genetic studies across large populations could never be achieved if legions of people refused to participate out of fear that the results could be misused.
Worries about discrimination have not come true—yet. Even though the Human Genome Project was completed in 2003, genetic testing has not become widespread, so there is little in the average person’s health record to divulge. And genome-wide analyses remain costly—as much as several thousand dollars each. What is more, scientists still lack standard techniques for making whole-genome scans useful for health risk assessment.
Nevertheless, in many societies—particularly the wealthy ones—genetic testing for multiple disorders will soon become routine. New technologies and scientific discoveries are making the tests more useful and affordable. The health care sector’s sweeping transition from paper to electronic records will also make genetic information more readily accessible. Safeguarding genetic privacy is more complicated than many people realize, and recently enacted laws such as the 2008 Genetic Information Nondiscrimination Act offer little protection. Better regulations must be developed soon, before testing spreads and abuses grow.
In spite of recent legislation, tougher laws are needed to prevent insurers and... more
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Genetic-testing company Navigenics has responded to the state of California's cease-and-desist letter with a novel defense: It doesn't actually test patients' genomes, it just analyzes 'em.
In a letter sent to the Health Department obtained by Wired.com, the company argues that it does not actually perform genetic tests, and therefore should not be regulated as a clinical laboratory under California state law.
Instead, Navigenics argues it merely applies algorithms to DNA data it receives from tests performed by a third-party, a licensed laboratory.
As we noted Monday, this regulatory battle hinges on the definition of a clinical laboratory test.
"Nothing in the definition of a clinical laboratory test supports a conclusion that the interpretation of the data resulting from such a test is itself a test," Navigenics wrote in its response.
Though abstruse, these definitions could shape the long-term future of genetic testing. The arguments boil down to whether or not the information contained in your DNA should be treated like blood or like data.
Navigenics is arguing that once the state-licensed lab turns a biological sample into digital data, DNA is no longer within the purview of health department laboratory regulation. Navigenics is just an information service, combining scientifically-published genetic disease correlation data with personal genotype data.
Whether or not the health department (or eventually the courts) will buy this argument remains to be seen. The state is reviewing responses from the thirteen companies it served with cease-and-desist letters.
According to Navigenics, it contracts the actual biological work to a Federally-certified and California-licensed lab run by Affymetrix, so it never touches the spit-containing DNA that forms the basis of genetic testing. What Navigenics receives from Affymetrix is merely digital data about a person's genetic variations.
In that way, it argues, the company merely interprets clinical lab tests, much like a physician would, and physicians are not regulated as clinical labs.
The state, on the other hand, holds that because Navigenics obtains the biological data, it is essentially doing the test.
Navigenics' also proposes a second line of defense relating to the necessity of including a physician in ordering a genetic test.
Navigenics has argued all along that it has a California physician who actually orders and receives the tests, but it is not clear whether any physician can order a test, or whether it had to be "your doctor" (whatever that means in today's health care system).Genetic-testing company Navigenics has responded to the state of California's... more
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kushan
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added this
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3 years ago
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