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Reanalysis & Reinterpretation

The Clinical Services Lab at HudsonAlpha can reinterpret a previously examined genome or exome, to include development of new symptoms or recently discovered genes. The lab can reanalyze data from both the CSL and outside laboratories, the option is available to do a targeted reanalysis of up to 25 genes or complete reanalysis of an entire dataset.

This test(s) was developed, and performance characteristics were determined by the HudsonAlpha Clinical Services Lab, LLC. The U.S. Food and Drug Administration (FDA) has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. These tests are used for clinical purposes, and therefore validation was done as required under the requirements of the Clinical Laboratory Improvement Act (CLIA) of 1988. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. The chance of a false negative or a false-positive result due to laboratory error cannot be completely excluded. These results should not be regarded as investigational or for research.