genTrue Hereditary Cancer Testing

genTrue hereditary cancer testing from True Health analyzes 26 genes known to increase risk for multiple cancers. Through next-generation sequencing technology and clinical resources, True Health gives clinicians and patients clinically actionable results based on national guidelines, and the support required to translate test results into better health outcomes.

The Need

Testing

Risk Assessment and Prior Authorization

FAQs

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The Impact of Hereditary Cancer

  • Up to 10% of cancers are due to inherited genetic changes (mutations), which are passed from parent to child.
  • If no preventive measures are taken, patients with inherited mutations are at much greater risk for developing cancer— up to 82% for breast and colon cancer.

1. Kuchenbaecker KB, et al. Risks of breast, ovarian, and contralateral breast cancer for BRCA1 and BRCA2 mutation carriers. JAMA. 2017; 317(23):2402-2416. 2. King MC, et al. Breast and ovarian cancer risks due to inherited mutations in BRCA1 and BRCA2. Science. 2003;302(5645):643-6. 3. Kohlmann W, et al. Lynch Syndrome. GeneReviews, 2014. https://www.ncbi.nlm.nih.gov/books/NBK1211/.

INCREASE IN LIFETIME CANCER RISK FOR PEOPLE WITH
AN IDENTIFIED HEREDITARY CANCER GENE MUTATION 1-3

A proactive approach is key.

The American Society of Clinical Oncology (ASCO) recommends genetic testing for all individuals with suspected hereditary cancer risk in situations where test results may affect medical management of the patient. The reality? According to a 2016 survey of women diagnosed with breast cancer, fewer than 30% received hereditary cancer testing despite having a high-risk family history. By understanding a patient’s family history and testing for inherited gene mutations, it is possible to uncover hereditary cancer risk—while there is still time to manage the risk and impact outcomes.

Comprehensive Testing

26 clinically actionable hereditary cancer genes

genTrue genetic testing includes 26 genes known to increase risk for multiple common cancers, including breast, colorectal, prostate, and others. This multi-gene approach allows clinicians to uncover more information in a single round of testing than with the previous single gene/single syndrome approach. Research1 shows that there is substantial overlap between clinical features of different hereditary cancer syndromes, further supporting the use of a pan-cancer, multi-gene approach.

In addition, True Health offers the ability for clinicians to test individual, single-site genes as needed for patients with specific mutations known in the family. When combined with personal and family cancer history, genTrue results offer a clinically actionable risk assessment, providing a solid foundation for more effective care plans. For clinicians who determine that hereditary cancer risk is present and that testing is medically necessary, genTrue testing ultimately provides evidence-based options to help clinicians detect gene mutations quickly and take action.

1. Saam J, Arnell C, Theisen A, Moyes K, Marino I, Roundy KM, Wenstrup RJ. Patients Tested at a Laboratory for Hereditary Cancer Syndromes Show an Overlap for Multiple Syndromes in Their Personal and Familial Cancer Histories. Oncology. 2015;89(5):288-93.   |  2. Buys SS, et al. A study of over 35,000 women with breast cancer tested with a 25-gene panel of hereditary cancer genes. Cancer. 2017; 123(10):1721-1730.

A 2017 STUDY OF BREAST CANCER PATIENTS SHOWS THAT A MULTI-GENE HEREDITARY CANCER ASSESSMENT MAY IDENTIFY:

genTrue Genes

APC C
ATM B Pa
BMPR1A C
BRCA1 B O Pr Pa
BRCA2 B O Pr Pa M
BRIP1 O

CDH1 B G
CDK4 M
CDKN2A M Pa
CHEK2 B Pr
EPCAM C E O G
MLH1 C E O G

MSH2 C E O G
MSH6 C E O G
MUTYH C
NBN B Pr
PALB2 B Pa

PMS2 C E O G
POLD1 C
POLE C
PTEN B C E
RAD51C O

RAD51D O
SMAD4 C
STK11 B O C Pa
TP53O C Pr

C- Colorectal   B – Breast    O- Ovarian    Pa – Pancreatic    M- Melanoma   Pr- Prostate    E- Endometrial (Uterine)     G- Gastric 

Medical Management

Take Action with Easy-to-Interpret Reporting

.

No pathogenic variants detected in the genes tested.

Follow personalized and population guidelines outlined in the genTrue report.

.

A genetic change was detected, but clinical significance is currently unknown.

Follow personalized and population guidelines outlined in the genTrue report.

.

A genetic change was detected. Patient has increased cancer risk.

Consider increased preventive measures outlined in the genTrue report.

genTrue Report

  • Simplified format with actionable information   ……………………………………………………………

  • Health management options customized to individual results, based on NCCN Guidelines®

  • Patient Guide with explanation of results and next steps

Based on a patient’s individual test results, the easy-to-read genTrue lab report offers specialized management options based on National Comprehensive Cancer Network (NCCN) Guidelines®. This means for patients who test positive, you can tailor a care plan to your patient’s specific risks. Preventive and early detection measures may include increased surveillance, chemoprevention, surgical intervention, and family testing. Studies have shown these options increase survival in patients with hereditary cancer risk.1,2

All genTrue test results are accompanied by a personalized Patient Guide to help you and your patients interpret the results and understand the next steps. Following genTrue testing, True Health’s genetic experts are available to help you identify the specialty referrals and resources you and your patients need to proactively manage cancer risks.

1. Ingham, SL, et al. Risk-reducing surgery increases survival in BRCA1/2 mutation carriers unaffected at time of family referral. Breast Cancer Res Treat. 2013;142(3):611-8.   |  2. Domchek, SM, et al. Association of risk-reducing surgery in BRCA1 or BRCA2 mutation carriers with cancer risk and mortality. JAMA. 2010;302(9):967-975. 

Connect with True Health’s Medical Services & Genetic Counseling experts: 1.877.494.0030

Who Should Receive Testing?

Identifying Patients at Risk for Hereditary Cancer

Recognizing the factors that make a patient a candidate for hereditary cancer testing is critical to preventing the disease, delaying its onset, or diagnosing cancer at an earlier stage, while better outcomes may still be achievable. Patients may be at risk if they have personal or family history of any of the following:

RARE

Any member of the family with one of these at any age:

  • Male breast cancer
  • Triple negative breast cancer
  • Ovarian cancer
  • Colorectal cancer with abnormal MSI/IHC, MSI-associated histology
  • Endometrial (uterine) cancer with abnormal MSI/IHC
  • 20 or more gastrointestinal polyps

EARLY

Any member of the family with one of these:

  • Breast cancer
    (At age 45 or younger)
  • Colorectal cancer
    (At age 49 or younger)
  • Endometrial cancer
    (At age 49 or younger)

MULTIPLE

Any of the following on the same side of the family:

3 or more:*  Breast, ovarian, aggressive prostate, pancreatic cancer


3 or more:  Colorectal, endometrial, ovarian, gastric, pancreatic, other (renal/ureter pelvis, biliary tract, small bowel, brain, sebaceous adenomas)


3 or more:   Melanoma, pancreatic cancer

Patients with Ashkenazi Jewish heritage are also at higher risk, and may be eligible for testing.

* 2 or more if a Breast cancer is diagnosed at age 50 or younger
2 or more if any cancer from this group is diagnosed at age 49 or younger

Insurance Prior Authorization

True Health will work with patients’ insurance providers directly for prior authorization.

Frequently Asked Questions (FAQs) for Patients

Hereditary Cancer Testing

Q: What is hereditary cancer?

A: Roughly 1 in 3 Americans will develop cancer during their lifetime. However, when cancer runs in the family, your risk of developing cancer may be significantly higher.  Inherited genetic changes, called gene mutations, pass from parent to child over several generations, increasing risk for hereditary cancer.

Q: Am I at risk for hereditary cancer?

A: Talk to your clinician if cancer runs in your family. If any of the following apply, you may be at increased risk for hereditary cancer and/or eligible for testing.

  • You have several close family members with cancer
  • You have a close relative who has been diagnosed with cancer before age 50
  • You have a family member with multiple types of cancer

The True Health genTrue hereditary cancer test provides extensive insight into your risk for hereditary cancer. We look for potentially cancer-causing changes in a broad range of genes that are associated with the most common hereditary cancer types.

Q: What cancer types does genTrue test for?

A: genTrue tests for 26 genes that contribute to risk for multiple cancer areas, including breast, colorectal, prostate, ovarian, endometrial and more. See our gene list.

Q: How can I learn more about genTrue Testing?

A: Download our brochure, or call us at 1.877.443.5227. Download patient brochureDownload clinician guide.

Specimen Collection

Q: What kinds of specimens are accepted for genTrue testing?

A: True Health accepts both blood and saliva specimens for genTrue testing. Specimen collection should take place with a licensed healthcare professional.

Q: What can I expect during my blood draw?

A: Your clinician will take blood from your arm using a needle. Your blood sample will then be sent to the True Health laboratory for testing.

Q: What can I expect when I submit a saliva sample?

A: Your clinician will ask you to spit a small amount of saliva into a funnel. Your saliva sample will then be sent to True Health for testing.  It is important that you do not eat, drink, or chew gum for 30 minutes before your saliva collection.

Insurance Requirements

Q: Does my insurance require prior authorization for hereditary cancer testing?

A: Some insurers require prior authorization before hereditary cancer testing can be performed. The pre-authorization process can sometimes delay testing and reporting of results.  It is important to follow the requirements of your specific health plan. True Health can help you and your clinician through this process. Give us a call at 1.877. 494.0030.

Q: What does the prior authorization process entail?

A: The prior authorization process may vary depending on your insurer. The process typically includes steps such as informed consent, providing family history, and/or pre-test genetic counseling.

Q: What forms will my clinician and I need to complete for prior authorization?

A: Most insurers have specific forms you must complete prior to being tested for certain genes.  Some forms must be completed by you, some must be completed by your clinician, and some must be completed by a Genetic Counselor. Find and download your prior authorization forms.

Q: Will my insurance company see my results?

A: True Health will release your test results to you and the clinician who ordered the test. Your insurer may also request a copy of your lab results in order to confirm medical necessity and pay your insurance claim. There are federal and state laws to protect against genetic discrimination. The Genetic Information Nondiscrimination Act of 2008 (GINA) prohibits discrimination in employment and health insurance based on genetic information. For more information, see http://www.geneticalliance.org/advocacy/policyissues/geneticdiscrimination .

Billing

Q: Is genTrue testing covered by insurance?

A: Most insurance carriers cover medically appropriate genetic testing services for hereditary cancer.  Coverage and prior-authorization requirements may vary depending on your insurer and health plan. Your clinician should collect your insurance information prior to collecting your blood or saliva specimen, and submit it to True Health. True Health will contact your insurer to confirm your coverage and any required copay, coinsurance, or deductible. The True Health billing team will notify you in advance if your estimated out-out-pocket (including copay, coinsurance, or deductible according to your health plan) is over $300.  If your health plan’s deductible requirement has not yet been met, this payment will be required prior to testing.

Q: Will you accept my secondary insurance?

A: Yes. Be sure to provide your clinician with your secondary insurance information at the same time you provide your primary insurance information, so that they may submit it to True Health. In addition, you will be required to complete a Coordination of Benefits (COB) form, along with a photocopy of your secondary insurance card.

Q: I have received a notice from my insurance. What do I do?

A: When processing a claim for lab testing, most insurers send patients a notice in the mail called an Explanation of Benefits (EOB). The EOB is not a bill. If you need help understanding this notice, call us at 1.877.494.0030 for assistance.  If we have not received our copy of the EOB at the time of the call, we may request you send us a copy by mail or fax at 1.844.333.0663 so we can review it together and help you understand the information. If the notice you received is NOT an EOB, it may be a denial of your claim. Your claim may be denied for several reasons, including requiring additional medical records or other types of information. True Health will work with you and your clinician to provide this information to your insurer as quickly as possible. Call us at 1.877.494.0030 for assistance.

Q: Can I pay for genTrue hereditary cancer testing without going through my insurance?

A: Yes. If you choose to self-pay for genTrue testing, please contact us at 1.877.494.0030 or friscobilling@truehealthdiag.com. We accept payment by check, card (Visa, MasterCard, Discover), and money order.

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