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Many Questions About FDA Regulation of LDTs

Federal agency intends to look at patient risk as a primary factor in how it will regulate LDTs

CEO SUMMARY: Ask most pathologists and laboratory administrators about the FDA’s intent to regulate laboratory-developed tests (LDTs), and they will likely answer that it is to control web-based direct-to-consumer lab testing companies and the rapidly- growing number of proprietary tests. Although that is true, any move to regulate LDTs also has the potential to cover …

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