CeliacDx: For Celiac Disease Diagnosis
Test Introduction
Three Tests | One Kit | One Celiac Disease Diagnosis
CeliacDx is a comprehensive assessment of the three gold standard tests for celiac disease: tTG
antibodies, small bowel biopsy, and HLA-DQ2/DQ8 genetics. Results are interpreted in context
of the patient’s symptoms to render an unequivocal celiac disease diagnosis for every patient.
All three tests can be performed by PacificDx Laboratory. If all three gold standard tests
[antibody, biopsy, genetics] have been previously performed, PacificDx pathologists will deliver
unequivocal celiac disease results based upon the previous testing. If any test results are
missing, the relevant patient sample (serum for antibodies, biopsy specimen, cheek swab for
genetics) can be included in the kit and sent to PacificDx. Testing will be performed by our
laboratory. All test results will be incorporated into the comprehensive report. Insurance will
only be billed for the pathology consultation and testing performed by PacificDx.
For more information about ordering CeliacDx, visit www.celiacdx.com.
Test Description
CeliacDx is our physician ordered celiac genetics testing and telehealth pathology consultation service for celiac disease diagnosis.
Test Ordering
CeliacDx is now available for purchase directly through the Target-Genomics website. PacificDx performs the technical testing components. PacificDx developed the technical component of this test and determined its analytical performance characteristics. It has not been cleared or approved by the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Sample Collection and Shipping Instructions
CelicDx™ is available for purchase directly through the Target-Genomics website. The test kit contains all required materials for at-home collection and shipping the kit to PacificDx for molecular analysis.
For Tissue analysis, FFPE Tissue Blocks are the preferred sample type versus slides. If sending unstained slides, please send a minimum of 10-15 slides, freshly cut at 4-6 microns. Archival-cut slides are acceptable if they are less than 30 days old.
