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Targeted Variant Testing (Sanger Sequencing)

A next-generation DNA sequencing technique focusing on amplicons and specific genes. It identifies heterozygous base positions or small insertions or deletions in genomic DNA is often employed to locate mutations or polymorphisms in diploid organisms, detect genetic rearrangements, and uncover rare variants.

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.