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FDA gets job of setting up genetic test criteria

This article was originally published in Clinica

Executive Summary

An interagency group has decided to give the FDA full responsibility for coming up with a regulatory scheme for reviewing genetic tests. The Secretary's Advisory Committee on Genetic Testing (SACGT), a public-private advisory panel established in 1999 to advise the Secretary of Health and Human Services (HHS) on a variety of policy issues regarding genetic testing, had initially sought a new classification algorithm for these tests that would have set genetic testing apart from other forms of diagnostics.

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