Laboratories must conduct assay validations to ensure that accurate, reliable data is provided to physicians and patients, but it is not a routine task for most labs. Laboratory developed test (LDT) validation is a complex task, requiring specialized skills. Because most labs go through the validation process infrequently, in-house teams often have limited experience. If not carefully planned, mistakes in the validation process can lead to unexpected expenses and timelines that can stretch up to 12 months. For labs running on tighter margins than ever before, an efficient and cost-effective validation process is critical.
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