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Hereditary cancer screening made accessible

Counsyl patients

The Counsyl Inherited Cancer Screen analyzes up to 36 genes associated with hereditary cancers in women and men.

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Victoria R.Counsyl Inherited Cancer Screen patient

CounsylCounsyl Providers

Hereditary cancer screening made accessible for your patients, for your practice

Industry-leading quality and accuracy

Our CLIA-certified clinical genomics lab is among the most automated and advanced in the world, with technology and processes that deliver high-quality DNA testing with greater efficiency, allowing for reduced costs and rapid turnaround times. Our next generation sequencing platform is scientifically validated, with >99.99% sensitivity, specificity and accuracy.

On-demand genetic counseling

We believe that every patient should have the benefits of genetic counseling. We employ over 40 board certified genetic counselors. Our in-house team (available on-demand) can provide consultation directly to patients, serving as an extension of your practice.

End-to-end workflow support

We help to minimize the administrative work associated with testing. We can integrate with your EMR, submit prior authorization requests, and document all patient interactions in an online portal—enabling you and your staff to spend more time focused on patient care.

Affordable and widely covered

Our extensive insurance network includes most payers, and our automated cost estimates provide price transparency for your patients and help to take billing conversations off your hands. Affordable payment options are available for patients who lack adequate coverage.

Results of the highest standard

Our technology, processes, and team of experts ensure that our results meet the highest industry standards. All variants are curated by our genetic counselors and PhD curators according to ACMG guidelines using multiple lines of evidence. It is our policy to freely contribute de-identified information to the public variant databases for the benefit of the global medical community.

Associated cancers
Breast, ovarian, endometrial, colorectal, pancreatic, gastric, prostate, thyroid, melanoma, and neuroendocrine tumors
Who to screen
Men and women with a personal or family history of cancer
Sample type
4mL blood, or saliva sample
Methodology
Next-gen sequencing
Turnaround time
Results in 2 weeks on average
View full gene list

Relevant clinical insights that make a difference

The Inherited Cancer Screen Comprehensive Panel includes only genes with clear cancer risks and patient management guidelines. So if a patient has a positive result, there are actions that can be taken to address the risk. Testing options from Counsyl are flexible and include comprehensive multi-gene panels, as well as the ability to select specific, individual genes.

Examples of selected genes, with associated cancer risks:

 
GeneAssociated cancers

BRCA11

Breast (50-85% lifetime risk)
Ovarian (24-45% lifetime risk)
Pancreatic (1-3% lifetime risk)

MLH1 (Lynch syndrome)2

Colon (40-80% lifetime risk)
Endometrial (25-60% lifetime risk)
Ovarian (4-24% lifetime risk)

RET (Multiple endocrine neoplasia, Type 2)3

Medullary thyroid (98-100% lifetime risk)

Current guidelines leave out many patients who may benefit from hereditary cancer screening

Identifying carriers of BRCA, Lynch syndrome, and other cancer-associated genes allows you to provide important, potentially life-saving preventive care. However, every year thousands of women who don’t meet coverage guidelines are diagnosed with mutation-associated cancers.

50% of BRCA1/BRCA2 carriers missed

A 2014 population study discovered that “50% of families found to harbor BRCA1 or BRCA2 mutations had no history of breast or ovarian cancer that would have triggered clinical attention.”4

30% of Lynch syndrome carriers missed

An analysis of positive rates of patients undergoing panel testing showed that 30% of patients with Lynch syndrome mutations “did not meet corresponding criteria.”5

73% with ovarian cancer missed

73% of BRCA carriers with ovarian cancer would not have qualified for testing before their diagnosis according to existing guidelines.6

 

Access for all patients with elevated risk

Counsyl enables screening for all individuals at risk of developing hereditary cancer, so you can identify more carriers and take action based on the insights provided by the results.

The examples below demonstrate differences between risk level and those who qualify according to guidelines.

 
Patient typeRisk levelQualify for testing under current criteria7

Individuals with extensive family or personal cancer history

Extensive cancer history can include:

  • Personal history of cancer diagnosed at a young age (under 45-50).
  • Extensive family history of breast, ovarian, pancreatic, endometrial, or colorectal cancer, particularly when diagnosed under age 50.
High8Yes

Individuals with suggestive family or personal cancer history that would not meet guidelines

Suggestive cancer history can include:

  • Personal history of cancer diagnosed under 65.
  • Family history of breast, ovarian, pancreatic, endometrial, or colorectal cancer under 65.
Elevated9No

Individuals of Ashkenazi Jewish decent with limited or no personal or family history of cancer

  • 1 in 40 Ashkenazi Jewish women are carriers of a BRCA mutation.10
  • >60% of Ashkenazi Jewish BRCA carriers wouldn't qualify for testing based on personal/family history.11
ElevatedNo
Victoria, Counsyl patient
I knew I wanted to find out whether I’d inherited the genetic mutation so I could do what I could to combat it.Victoria R.
Counsyl Inherited Cancer Screen patient,
negative for BRCA1 and BRCA2
Read her story

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References:1 Information in table from GeneReviews and Genetic/Familial High Risk Assessment: Breast and Ovarian Version 2.2015. NCCN Clinical Practice Guidelines in Oncology. 2 Information in table from Genetic/Familial High Risk Assessment: Colorectal Version 1.2015. NCCN Clinical Practice Guidelines in Oncology. 3 Moline J, Eng C. Multiple Endocrine Neoplasia Type 2. 1999 Sep 27 [Updated 2013 Jan 10]. In: Pagon RA, Adam MP, Ardinger HH, et al., editors. GeneReviews® [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2014. 4 King MC, Levy-Lahed E, Lahed A. Population-Based Screening for BRCA1 and BRCA2. JAMA. 2014;312(11):1091-1092. doi:10.1001/jama.2014.12483. 5 LaDuca H, Stuenkel AJ, Dolinsky J et al. Utilization of multigene panels in hereditary cancer predisposition testing: analysis of more than 2,000 patients. Genetics in Medicine (2014) 16, 830–837. doi:10.1038/gim.2014.40. 6 Finch A, Bacopulos S, Rosen B et al. Preventing ovarian cancer through genetic testing: a population-based study. Clin Genet. 2014 Nov;86(5):496-9. doi: 10.1111/cge.12313. 7 Insurance coverage for testing for a particular patient may vary depending on product, location, specific benefit plan or the payer’s medical policy guidelines. 8 Genetic/Familial High Risk Assessment: Breast and Ovarian Version 2.2015. NCCN Clinical Practice Guidelines in Oncology. 9 Frank TS et al. Clinical Characteristics of Individuals With Germline Mutations in BRCA1 and BRCA2: Analysis of 10,000 Individuals. Journal of Clinical Oncology. 20:1480-1490, 2002. 10 Robles-Diaz L, Goldfrank DJ, Kauff ND et al. Hereditary ovarian cancer in Ashkenazi Jews. Fam Cancer. 2004;3(3-4):259-64. 11 Metcalfe KA, Poll A, Royer R et al. A Comparison of the detection of BRCA mutation carriers through the provision of Jewish population-based genetic testing compared with clinic-based genetic testing. Br J Cancer. 2013 Aug 6; 109(3): 777–779. doi: 10.1038/bjc.2013.309.

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