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FDA Lists Potentially Avoidable Harms in 20 LDT Case Studies, Including Tests from Duke, Caris and Genomic Health

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Ahead of a Capitol Hill hearing this week on the role of the FDA in the regulation of laboratory-developed tests, the federal agency published a report of 20 case studies that illustrated the possible harms presented to patients when laboratories do not comply with FDA requirements.

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Conor Hale
Conor Hale
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