ATM, BRCA1, BRCA2, CHEK2, EPCAM, HOXB13, MLH1, MSH2, MSH6, NBN, PMS2, TP53 - 12 genes
Rush / STAT - AVAILABLE
Del / Dup - INCLUDED
MCC - AVAILABLE
|Seq||81216x1, 81292x1*, 81295x1*, 81298x1*, 81317x1*, 81403x1, 81405x1, 81479x4|
|Del/Dup||81213x1*, 81294x1*, 81297x1*, 81300x1*, 81319x1*, 81403x1, 81404x1, 81479x3|
|Seq & Del/Dup||81211x1*, 81292x1*, 81294x1*, 81295x1*, 81297x1*, 81298x1*, 81300x1*, 81317x1*, 81319x1*, 81403x1, 81404x1, 81405x1, 81479x6|
|*||CPTs listed under CLAB2016 can be found on CMS.gov Fee Schedule released in January 2016. (Reference: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Clinical-Laboratory-Fee-Schedule-Files.html, Alternative: http://fulgentgenetics.com/public/cptdocs/CLAB2016v1.xls)|
|**||CPTs are based on the genes listed. Adding or removing genes will change the CPTs. In some cases, a CPT may require a specific list of genes while performing both sequencing and deldup to qualify. Fulgent bases the CPT for each Gene on multiple sources: CLAB2016v1, AMA Molecular Pathology Tier 2 Gene Designation Chart, and AMA CPT 2016. Call for more details.|
Blood (two 4ml EDTA tubes, lavender top) or Extracted DNA (3ug in TE buffer) or Buccal Swab or Saliva (kits available upon request). See How to Order for more details.
All sequencing technologies have limitations. Although next generation sequencing technologies and our bioinformatics analysis significantly reduce the contribution of pseudogene sequences or other highly-homologous sequences, these may still occasionally interfere with the technical ability of the assay to identify pathogenic variant alleles in both sequencing and deletion/duplication analyses. This assay will not detect certain types of genomic alterations which may cause disease such as, but not limited to, translocations or inversions, repeat expansions (eg. trinucleodes or hexanucleodes), alternations in regulatory regions or deep intronic regions (greater than 20bp from an exon). This assay is not designed or validated for the detection of somatic mosaicism or somatic mutations.