Color Test for Hereditary Cancer Screening
What is the Color Test?
Help your patients learn their genetic risk for the most common hereditary cancers.
Color analyzes 30 genes – including BRCA1 and BRCA2 – to help women and men understand their risk for the most common hereditary cancers, including breast, ovarian, colorectal, pancreatic and other cancers.
The Color Experience
Comprehensive testing
Color analyzes 30 genes known to impact hereditary cancer risk – including BRCA1 and BRCA2. Color’s custom software and expert team provide clinical-grade genetic testing at a fraction of the price.
Complimentary genetic counselling
Dynacare offers patients and their healthcare providers access to our team of genetic counsellors to answer any questions you may have about the Color Test or your patient’s results.
Informative results
Knowledge of an increased genetic risk can help you develop a personalized plan for your patient designed to prevent or detect cancer at an earlier and more treatable stage.
High-quality results
Cutting edge lab, team and processes generate results you can trust.
- Color performed two blinded studies to assess the validity of the Color test. Over 700 samples were studied, and all genetic variants were detected with greater than 99% accuracy.
- Color’s CAP-accredited and CLIA-certified laboratory uses the newest technology, including barcoding and advanced liquid-handling robots, to ensure the integrity of every result.
- The quality of every sample is checked multiple times as it moves through the sequencing and interpretation process.
- Color’s Ph.D. and M.D. scientists use state-of-the-art tools to classify variants according to ACMG guidelines. Reported variants are confirmed by another independent test methodology are re-reviewed every 6 months. Anonymized variants are shared with public genomic databases in an effort to advance understanding of genetic disease. Every genetic variant that is reported is confirmed by another independent test methodology.
- A certified medical professional reviews every result before it is released.
Read Color’s white paper on methodology and validation
Why order the test?
Knowing your patient has a mutation in one of the 30 genes analyzed – including BRCA1 and BRCA2 – enables you to develop a personalized plan for your patient designed to prevent or detect hereditary cancer at an earlier or more treatable stage. It may also allow for access to treatment options which require proof of positive genetic test results.
Why mutations matter
About 10-15% of most cancers are due to inherited genetic mutations.[1][2][3][4]
Hereditary cancer is caused by an inherited genetic mutation. It is typical to see a recurring pattern of cancer across two to three generations—like multiple individuals diagnosed with the same type of cancer(s) and individuals diagnosed with cancer much younger than average. Everyone has a risk of carrying a mutation, regardless of family history, however the risk increases with the number of cases of cancer in a family.
Familial cancer refers to cancer that appears to occur more frequently in families than is expected from chance alone. While no specific mutation has been linked to these cancers, familial cancer may have a hereditary component that has not yet been identified.
Sporadic cancer refers to cancer that occurs due to spontaneous mutations that accumulate over a person’s life. Sporadic cancer cannot be explained by a single cause. There are several factors, such as aging, lifestyle, or environmental exposure, that may contribute to the development of sporadic cancer.
A mutation can greatly increase one’s risk for developing cancer.
Mutations in the genes covered by the Color Test are not common, but when present they significantly increase the chances of cancer.
For example, a BRCA1 mutation can increase a woman’s chance of breast cancer up to 81% by age 80.[5] An APC gene mutation can increase a man or woman's chances of colorectal cancer up to 70-100% by age 80 without surgical intervention.[6],[7]
Detecting cancer early improves the odds of survival.
The 5-year survival rates for cancers covered by the Color Test increase dramatically when they are caught at an earlier and more treatable stage.[8]
Genes covered
The Color Test analyzes the most relevant genes for mutations that could increase your patient’s risk for breast, colorectal, melanoma, ovarian, pancreatic, prostate*, stomach, and uterine cancers.
* Please note that research and screening guidelines on genes associated with hereditary prostate cancer are still in their early stages. It is part of the Color service to keep you updated if any information related to your results changes.
** Only positions known to impact cancer risk analyzed: CDK4: only chr12:g.58145429-58145431 (codon 24) analyzed, EPCAM: only large deletions and duplications including 3’ end of the gene analyzed, GREM1: only duplications in the upstream regulatory region analyzed, MITF: only chr3:g.70014091 (including c.952G>A) analyzed, POLD1: only chr19:g.50909713 (including c.1433G>A) analyzed, POLE: only chr12:g.133250250 (including c.1270C>G) analyzed.
*** PMS2: Exons 12-15 not analyzed.
How does the Color Test work?
Step 1: Complete a Color requisition
Complete and sign a Color requisition and give it to your patient. You can obtain the requisition here.
Step 2: Your patient provides a saliva sample.
If you do not have kits in your office, your patient can simply call us at 888.988.1888 and we will ship a Color kit to their home. Your patient then sends the sample to our lab with the requisition, completed health history, informed consent and payment forms.
Step 3: Receive results.
On average, results are ready 3-5 weeks after the sample is received.
Step 4: Consult with genetic counsellors at no additional cost.
Dynacare offers you and your patient optional access to our team of genetic counsellors to answer any questions you may have.
Results
Most people receive a negative result.
This means no mutations associated with an increased risk for hereditary cancer were identified in any of the 30 genes analyzed.
While this can be reassuring, it does not eliminate a patient’s risks. Environmental and lifestyle factors and family history without a known genetic link account for the majority of cancers.
A small percentage of people receive a positive result.[9]
This means a mutation that increases your risk for cancer was identified. This result does not mean that the patient has cancer or that they will definitely develop cancer in their lifetime. But it is important to discuss and design a personalized screening and prevention plan. A referral to a Genetics Centre is recommended for these patients.
Because mutations can impact risk for multiple cancers, we may come across information about the patient’s genetic risk for cancers not targeted by the Color Test, like kidney and thyroid cancer. If we believe the patient’s risk for these cancers are increased due to a mutation, we will let you know.
Variants of uncertain significance.
It is common to see changes in genes that require further research to determine if they are associated with an increased risk for developing cancer. Most are eventually found to be harmless, and we will try to contact the healthcare provider when they are further classified.[10][11][12]
In this situation, personal and family history should be used to formulate a screening and prevention plan.
Results may affect relatives.
A patient’s results could be useful to their relatives, regarding their own chances of developing cancer. Patients can be encouraged to share their results with relatives, as testing may be useful for them as well.
Genetic counselling with every Color test.
Dynacare offers you and your patient complimentary access to our team of genetic counsellors to answer any questions you may have about the Color Test and your patient’s results. You may also request a pre-test genetic counselling session for your patient. Genetic counselling is available in English and French. To schedule a telephone consultation, call 888.988.1888.
To learn more, contact us at 888.988.1888 or DynacareNext@dynacare.ca
Access our Color patient brochure
Access our Color physician fact sheet
Access our Color forms
References
[1] Tung N, Battelli C, Allen B, et al. Frequency of mutations in individuals with breast cancer referred for BRCA1 and BRCA2 testing using next-generation sequencing with a 25-gene panel. Cancer. January 2015;121(1):25-33. Pubmed Abstract
[2] Pal T, Permuth-Wey J, Betts JA, et al. BRCA1 and BRCA2 mutations account for a large proportion of ovarian carcinoma cases. Cancer. December 2005;104(12):2807-16. Pubmed Abstract
[3] Risch HA, McLaughlin JR, Cole DE, et al. Prevalence and penetrance of germline BRCA1 and BRCA2 mutations in a population series of 649 women with ovarian cancer. Am J Hum Genet. March 2001;68(3):700-10. Pubmed Abstract
[4] Claus EB, Risch N, Thompson WD, et al. The calculation of breast cancer risk for women with a first degree family history of ovarian cancer. Breast Cancer Res Treat. November 1993;28(2):115-20. Pubmed Abstract
[5] King MC, Marks JH, Mandell JB, New York Breast Cancer Study Group. Breast and Ovarian Cancer Risks Due to Inherited Mutations in BRCA1 and BRCA2. Science. October 2003; 302(5645):643-6.
[6] Jasperson KW, Tuohy TM, Neklason DW, Burt RW. Hereditary and familial colon cancer. Gastro. 2010 Jun; 138(6):2044-58.
[7] Burt RW, et al. Genetic testing and phenotype in a large kindred with attenuated familial adenomatous polyposis. Gastro. 2004 Aug; 127(2):444-51.
[8] SEER Stat Fact Sheets: Breast Cancer. Published November 2013. National Cancer Institute
[9] Tung N, Battelli C, Allen B, et al. Frequency of mutations in individuals with breast cancer referred for BRCA1 and BRCA2 testing using next-generation sequencing with a 25-gene panel. Cancer. January 2015;121(1):25-33. Pubmed Abstract
[10] Eggington JM, Bowles KR, Moyes K, et al. A comprehensive laboratory-based program for classification of variants of uncertain significance in hereditary cancer genes. Clin Genet. September 2014;86(3):229-37. Pubmed Abstract
[11] Easton DF, Deffenbaugh AM, Pruss D et al. A systematic genetic assessment of 1,433 sequence variants of unknown clinical significance in the BRCA1 and BRCA2 breast cancer-predisposition genes. Am J Hum Genet. November 2007;81(5):873-83. Pubmed Abstract
[12] Akbari MR, Zhang S, Fan I, et al. Clinical impact of unclassified variants of the BRCA1 and BRCA2 genes. J Med Genet. October 2011;48(11):783-6. Pubmed Abstract