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23andMe's 2015 FDA authorization was for Bloom Syndrome and other Carrier Status reports, and we have continued to release additional Carrier Status reports over time. Since then, 23andMe has continued to seek FDA authorization to offer new types of reports.
- 23andMe's Updates Regarding FDA's Review
After discussion with officials from the Food and Drug...
- 23andMe's Updates Regarding FDA's Review
After discussion with officials from the Food and Drug Administration today, 23andMe will comply with the FDA’s directive and stop offering new consumers access to health-related genetic tests while the company moves forward with the agency’s regulatory review processes.
16 Οκτ 2024 · 23andMe and the contracted genotyping laboratory will retain your genetic Information, date of birth, and sex as required for compliance with legal obligations, pursuant to the federal Clinical ...
26 Νοε 2013 · In July 2012 23andMe submitted its first application for FDA clearance and followed on with another submission at the end of August. We received feedback on those submissions and acknowledge that we are behind schedule with our responses. This is new territory for both 23andMe and the FDA.
25 Νοε 2013 · The accuracy of 23andMe's DNA tests is central to FDA's concerns. A false positive result could lead consumers to seek unnecessary and possibly harmful screening or treatment, regulators worry, while a false negative could allow a major risk to go unnoticed.
20 Ιουν 2014 · A few days ago the US Food and Drug Administration accepted for review 23andMe’s submission for a new 510 (k) application. This submission is for one health report, and is part of the FDA’s regulatory review of our health product.
Your 23andMe profile homepage displays the status of your sample kit as it moves through each step of processing, from the time you order to the time you receive your results. Results typically take 4-6 weeks from the time a registered sample is received at the lab.
