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FDA ponders how to regulate next generation sequencing

from Managed Care

In light of the tremendous implications for overuse, misunderstanding, and abuse of a person’s genetic and disease-risk data, regulators have a lot to think about. The FDA is weighing the appropriate regulatory approach to next-generation sequencing, in which a single test potentially can be employed to identify a person’s millions of genetic variants. Results of such tests could be used to diagnose or predict a person’s risk of developing disease and to help physicians and patients to determine appropriate courses of prevention and treatment. more


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