Documentation of Clinical Validation Inconsistently Provided by LDT Developers

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A study described in a recent paper in the Journal of the National Cancer Institute analyzed the marketing of laboratory-developed tests (LDTs) for cancer by 55 different companies, academic institutions and other organizations.

The analysis concludes that a large number of tests are offered without documentation of clinical validation. For example, only half of the test developers provide references in support of the utility of tests for “non-standard” (i.e. not well-validated) somatic mutations.

Click here for the abstract.

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