Tuesday, March 25, 2008
Scientists are conducting large-scale scans of people's DNA to find the tiny molecular variations that help cause, or protect against, various diseases and behavioral traits. The goal is to be able to predict, on the basis of DNA tests, people's health risks and inspire them to consider preventive or mitigating measures.
Here are some of the diseases or traits for which gene associations have been found:
Tendency to wake up early
Responsiveness to certain medications
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WHAT AGENCIES AND LAWS SAY
¿ Food and Drug Administration: Can regulate genetic tests but, invoking "regulatory discretion," has opted not to do so for most of them.
¿ Centers for Medicare and Medicaid Services: Could require proficiency testing for genetic testing labs but has declined to do so, despite recommendations of a high-level Department of Health and Human Services advisory committee.
¿ Federal Trade Commission: Through its power to punish companies making "false claims," has some power over the genetic testing industry but has taken no enforcement actions to date.
¿ Clinical Laboratory Improvement Act: Requires that laboratory tests give accurate results but does not require that gene test results offer real medical value to people, thus leaving the market to decide which tests will sell.
¿ Both the House and Senate have passed versions of legislation that would prohibit discrimination by health insurers and employers on the basis of genetic test results. President Bush has expressed support for it, but Capitol Hill conflicts have stalled final passage.
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Whole Genome Analysis ($350,000)
¿ Determines the order of all 3 billion "letters" of a person's DNA code.
¿ Allows estimates of risk for all diseases and personality traits for which gene links have been found.
¿ Can be updated easily as scientists discover new disease- or trait-related genes.
Gene Chip ("SNP") analysis ($999 to $2,500)
¿ Focuses on about 50 specific markers in a person's DNA that predict the likelihood of about 20 diseases or traits.
¿ Some offer genetic counseling and/or additional ancestry information.
¿ Additional annual fees may apply to update with new chips as discoveries get made.