FDA通知关闭的所有消费级基因检测的药物指南报告

https://www.fda.gov/medical-devices/safety-communications/fda-warns-against-use-many-genetic-tests-unapproved-claims-predict-patient-response-specific
 
The FDA Warns Against the Use of Many Genetic Tests with Unapproved Claims to Predict Patient Response to Specific Medications: FDA Safety Communication

The FDA is alerting patients and health care providers that claims for many genetic tests to predict a patient's response to specific medications have not been reviewed by the FDA, and may not have the scientific or clinical evidence to support this use for most medications. Changing drug treatment based on the results from such a genetic test could lead to inappropriate treatment decisions and potentially serious health consequences for the patient.
 
主要原因是发现消费级基因检测后有些人会更改原本制定的用药方案, 而这些消费级基因检测的可靠性无法保证, 其结果用于改变治疗用药带来了严重的健康风险. 因此几乎所有美国的消费级基因检测在4月收到FDA警告后都停止了药物使用的检测报告.

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