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This test has been validated as a Laboratory Developed Test (LDT) under CLIA regulations. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA) and is not intended to diagnose, treat, cure, or prevent any disease or medical condition. Test results should be interpreted by a qualified healthcare provider in the context of the patient’s clinical history, symptoms, and other laboratory findings. At this time, this test is not available for residents of the State of New York.

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* All laboratory services used for sample processing are provided by partner laboratories who are CLIA-certified and HIPAA compliant