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These tests were developed and performance characteristics were determined by Fore Genomics, Inc. in collaboration with Fore’s service providers. The US Food and Drug Administration (FDA) has not approved or cleared these tests; however, FDA clearance 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.

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