On Nov. 22, 2013, the FDA sent a now-infamous letter to the genetic
research startup 23andMe, ordering the company to stop marketing some of
its personal DNA testing kits. In its letter, the agency told 23andMe
that it was concerned about the possibility of erroneous test results,
about false positives and false negatives. The FDA warned that false
positives – for example, being told that one has a high risk of breast
cancer when really one doesn’t – might lead customers to seek expensive
testing or medical treatment that they don’t really need. False
negatives – which are just the opposite – might lead customers to ignore
serious health problems or deviate from a prescribed treatment regime.
The company had been out of contact with the FDA since May of 2013, and
had not filed the required information to allay the bureau’s concerns.
When
word about the letter got out, the ever-ready machine of Internet
journalism whirred quickly to life. Defenders of the genetic research
firm argued that the information, if used properly and with a
physician’s supervision, is not only...
By Harold Brubaker, The Philadelphia Inquirer | 04.04.2024
Aggregated News
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The U.S. government must move “quickly and decisively” to avert substantial national security risks stemming from artificial intelligence (AI) which could, in the worst case, cause an “extinction-level threat to the human species,” says a report commissioned by the U.S...
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