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2018/3/27 Discussion Returning results: bout actionable results Patients want information about all findings from sequencing Thanks standards for analytical validity, different testing platforms . In 2013, the FDA directed 23andMe to cease selling Personal In February 2015, the FDA reclassified these kits to enable a regulatory path exempt from premarket revie2018/3/27 10 Discussion  Returning results: Genome sequencing producing massive amounts of data of unknown medical and social impact.  Return information about actionable results  Patients want information about all findings from sequencing  Privacy and confidentiality  Patients do not want their sequencing results ‘filtered’  New technology need data sharing to achieve common standards for analytical validity, different testing platforms.  Personal genetic testing:  In 2013, the FDA directed 23andMe to cease selling Personal Genomic Testing (PGS) kits.  In February 2015, the FDA reclassified these kits to enable a regulatory path exempt from premarket review. Thanks !
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