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HelpTest ID: COMCP Hereditary Common Cancer Panel, Varies
Ordering Guidance
Customization of this panel and single gene analysis for any gene present on this panel are available. For more information see CGPH / Custom Gene Panel, Hereditary, Next-Generation Sequencing, Varies.
Targeted testing for familial variants (also called site-specific or known mutations testing) is available for the genes on this panel. For more information see FMTT / Familial Variant, Targeted Testing, Varies. To obtain more information about this testing option, call 800-533-1710.
Testing minors for adult-onset predisposition syndromes is discouraged by the American Academy of Pediatrics, the American College of Medical Genetics and Genomics, and the National Society of Genetic Counselors.
Shipping Instructions
Specimen Required
Patient Preparation: A previous bone marrow transplant from an allogenic donor will interfere with testing. For instructions for testing patients who have received a bone marrow transplant, call 800-533-1710.
Specimen Type: Whole blood
Container/Tube:
Preferred: Lavender top (EDTA) or yellow top (ACD)
Acceptable: Green top (Sodium heparin)
Specimen Volume: 3 mL
Collection Instructions:
1. Invert several times to mix blood.
2. Send whole blood specimen in original tube. Do not aliquot.
Specimen Stability Information: Ambient 4 days/Refrigerated 4 days/Frozen 4 days
Additional Information:
1. Specimens are preferred to be received within 4 days of collection. Extraction will be attempted for samples received after 4 days and DNA yield will be evaluated to determine if testing may proceed.
2. To ensure minimum volume and concentration of DNA is met, the preferred volume of blood must be submitted. Testing may be canceled if DNA requirements are inadequate.
Specimen Type: Saliva
Patient Preparation: Patient should not eat, drink, smoke, or chew gum 30 minutes prior to collection.
Supplies: Saliva Collection Kit (T786)
Specimen Volume: 1 Swab
Collection Instructions: Collect and send specimen per kit instructions.
Specimen Stability Information: Ambient (preferred) 30 days/Refrigerated 30 days
Additional information: Due to lower quantity/quality of DNA yielded from saliva, some aspects of the test may not perform as well as DNA extracted from a whole blood sample. When applicable, specific gene regions that were unable to be interrogated will be noted in the report. Alternatively, additional specimen may be required to complete testing.
Forms
1. New York Clients-Informed consent is required. Document on the request form or electronic order that a copy is on file.
-Informed Consent for Genetic Testing (T576)
-Informed Consent for Genetic Testing (Spanish) (T826)
2. Molecular Genetics: Inherited Cancer Syndromes Patient Information Sheet (T519)
3. If not ordering electronically, complete, print, and send a Oncology Test Request (T729) with the specimen.
Useful For
Evaluating hereditary cancer for patients with a personal or family history suggestive of a hereditary cancer syndrome
Establishing a diagnosis of a hereditary cancer syndrome allowing for targeted cancer surveillance based on associated risks
Identifying genetic variants associated with increased risk for cancer, allowing for predictive testing, and appropriate screening of at-risk family members
Therapeutic eligibility with poly adenosine diphosphate-ribose polymerase (PARP) inhibitors based on certain gene alterations (eg, BRCA1, BRCA2) in selected tumor types
Genetics Test Information
This test utilizes next-generation sequencing to detect single nucleotide and copy number variants in 36 genes associated with hereditary cancer syndromes: APC (including promoters 1A and 1B), ATM, AXIN2, BARD1, BMPR1A, BRCA1, BRCA2, BRIP1, CDH1, CDK4, CDKN2A, CHEK2, DICER1, EPCAM (copy number variants only), GREM1 (upstream enhancer region duplication only), HOXB13, MEN1, MLH1, MSH2, MSH3, MSH6, MUTYH, NBN, NF1, NTHL1, PALB2, PMS2, POLD1, POLE, PTEN (including promoter), RAD51C, RAD51D, RET, SMAD4, STK11, TP53. For more information, see Method Description and Targeted Genes and Methodology Details for Hereditary Common Cancer Panel.
Identification of a disease-causing variant may assist with diagnosis, prognosis, clinical management, familial screening, and genetic counseling for hereditary cancer syndromes.
Method Name
Sequence Capture and Next-Generation Sequencing (NGS), Polymerase Chain Reaction (PCR), Sanger Sequencing and/or Multiplex Ligation-Dependent Probe Amplification (MLPA)
Reporting Name
Hereditary Common Cancer PanelSpecimen Type
VariesSpecimen Minimum Volume
Whole blood: 1 mL; Saliva: See Specimen Required
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Varies | Varies | ||
Clinical Information
Hereditary cancer syndromes account for approximately 5% to 10% of cancer cases.(1,2) Determining if there is a genetic risk factor contributing to cancer in an individual or family can be useful for tailoring surveillance plans, consideration of prophylactic risk reducing interventions, consideration of targeted treatments, and determining risk for family members.(3-9)
This panel evaluates 36 genes known to be associated with an increased risk of polyposis and several common cancers, including breast, colon, gastric, ovarian, pancreatic, prostate, skin, thyroid, and endometrial cancers. The risk for developing cancer, as well as other features associated with these syndromes, varies. Many of the genes on this panel have established cancer risk and National Comprehensive Cancer Network or expert group guidelines and recommendations for management.(3-8)
Indications for testing include but are not limited to:
-Individuals with multiple primary cancers
-Individuals with cancer diagnosed at young ages
-Individuals with a family history of multiple relatives with cancer
-Individuals whose family history of cancer may seem to overlap with more than one hereditary cancer syndrome
Reference Values
An interpretive report will be provided.
Interpretation
All detected variants are evaluated according to American College of Medical Genetics and Genomics recommendations.(1) Variants are classified based on known, predicted, or possible pathogenicity and reported with interpretive comments detailing their potential or known significance.
Clinical Reference
1. Richards S, Aziz N, Bale S, et al. Standards and guidelines for the interpretation of sequence variants: a joint consensus recommendation of the American College of Medical Genetics and Genomics and the Association for Molecular Pathology. Genet Med. 2015;17(5):405-424
2. Howlader N, Noone AM, Krapcho M, et al. SEER Cancer Statistics Review. 1975-2018. National Cancer Institute; Updated April 2021. Accessed September 9, 2024. Available at: https://seer.cancer.gov/csr/1975_2018/
3. Nagy R, Sweet K, Eng C. Highly penetrant hereditary cancer syndromes. Oncogene. 2004;23(38):6445-6470
4. Daly MB, Pal T, Berry MP, et al. Genetic/familial high-risk assessment: breast, ovarian, and pancreatic, version 2.2021, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2021;19(1):77-102
5. Gupta S, Provenzale D, Llor X, et al. NCCN Guidelines Insights: Genetic/familial high-risk assessment: colorectal, version 2.2019. J Natl Compr Canc Netw. 2019;17(9):1032-1041
6. Saslow D, Boetes C, Burke W, et al. American Cancer Society guidelines for breast screening with MRI as an adjunct to mammography. CA Cancer J Clin. 2007;57(2):75-89
7. Smith RA, Andrews KS, Brooks D, et al. Cancer screening in the United States, 2019: A review of current American Cancer Society guidelines and current issues in cancer screening. CA Cancer J Clin. 2019;69(3):184-210
8. Coit DG, Thompson JA, Albertini MR, et al. Cutaneous Melanoma, Version 2.2019, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2019;17(4):367-402
9. Haddad RI, Nasr C, Bischoff L, et al. NCCN Guidelines Insights: thyroid carcinoma, version 2.2018. J Natl Compr Canc Netw. 2018;16(12):1429-1440
10. Samadder NJ, Rigert-Johnson D, Boardman L, et al. Comparison of universal genetic testing vs guideline-directed targeted testing for patients with hereditary cancer syndrome. JAMA Oncol. 2021;7(2):230-237
Day(s) Performed
Varies
Report Available
21 to 28 daysTest Classification
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
81201
81408 x2
81162
81406 x4
81404
81403
81405 x2
81292
81295
81298
81307
81317
81319
81321
81351
81479
81479 (if appropriate for government payers)
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| COMCP | Hereditary Common Cancer Panel | 97656-3 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 614683 | Test Description | 62364-5 |
| 614684 | Specimen | 31208-2 |
| 614685 | Source | 31208-2 |
| 614686 | Result Summary | 50397-9 |
| 614687 | Result | 82939-0 |
| 614688 | Interpretation | 69047-9 |
| 614689 | Resources | 99622-3 |
| 614690 | Additional Information | 48767-8 |
| 614691 | Method | 85069-3 |
| 614692 | Genes Analyzed | 48018-6 |
| 614693 | Disclaimer | 62364-5 |
| 614694 | Released By | 18771-6 |
Testing Algorithm
For more information see Lynch Syndrome Testing Algorithm.
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