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STAT Whole Genome Sequencing

At the HudsonAlpha Clinical Services Lab, STAT whole genome sequencing is being used to revolutionize care in NICUs across the nation. Using STAT whole genome sequencing, clinicians are able to quickly identify disease-causing genetic mutations in NICU patients that have not received a diagnosis using standard testing. Our STAT whole genome sequencing pipeline returns a preliminary report to the clinician in as little as 5 days, allowing clinicians to make a fast and informed diagnosis.

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.