The commentary by Kilbride et al¹ emphasizes that there must be greater clarity for patients and providers on the actionability of genomic results from direct-to-consumer (DTC) tests, and we agree. The US Food and Drug Administration (FDA) regulatory review of DTC tests evaluates their analytical validity (whether tests reliably and accurately measure what they intend to measure) and clinical validity (whether the measurement is predictive of a certain state of health) but does not evaluate their clinical utility or the personal benefit a user of the test results should expect to receive from the intervention.² The FDA also regulates the claims a company makes about the DTC test in hopes of providing better care for patients; however, it is apparent that certain regulatory language can cause significant confusion.

中文翻译：

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直接消费类药物遗传学测试也需要明确。

Kilbride等人¹的评论强调，对于患者和提供者来说，直接面向消费者（DTC）测试的基因组结果的可操作性必须更加明确，我们同意。美国食品药品监督管理局（FDA）对DTC测试的监管审查会评估其分析有效性（测试是否可靠，准确地测量了他们打算测量的内容）和临床有效性（是否该测量可以预测某种健康状况），但未进行评估评估其临床效用或测试结果使用者应从干预中获得的个人利益。^2个FDA还对一家公司对DTC测试提出的索赔进行规范，以期为患者提供更好的护理。但是，很明显，某些法规语言可能会引起很大的混乱。