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 Nada Hassanein, New Jersey Monitor | 03.14.2024
Aggregated News
The U.S. Food and Drug Administration late last year approved two breakthrough gene therapies for sickle cell disease patients. Now a new federal program seeks to make these life-changing treatments available to patients with low incomes — and it could...
By Daniel Gilbert, The Washington Post | 03.07.2024
Aggregated News
Vitaly Kushnir’s fertility clinic offers to screen an embryo to predict a baby’s sex, but the service can lead to ethically murky territory, like when a couple wanted it so their first child could be a boy.
The Center for Genetics and Society is fiscally sponsored by Tides Center, a 501(c)(3) non-profit organization.
Please visit www.tides.org/state-nonprofit-disclosures for additional information.