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About Helio Genomics

The HelioLiver test is available as a laboratory-developed test (LDT). HelioLiver LDT was developed and its performance characteristics were determined by Helio Genomics. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA). As an LDT, this test is regulated under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, which ensures quality laboratory testing. This test is intended for clinical purposes and should not be regarded as investigational or for research use only.

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