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MELARIS

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Overview

Etiology and Clinical Features of Hereditary Melanoma Syndrome

There are about 62,000 new cases of melanoma in the United States each year—and the incidence is increasing.37 Approximately 10% of cases are hereditary, and may have a strong link to the development of pancreatic cancer.

Family linkage studies identified an autosomal dominant melanoma gene located on chromosome 9p21. 40

  • This gene, called p16 (also known as CDKN2A, INK4A, or MTS1), accounts for up to 40% of hereditary melanoma cases
  • p16 is a tumor suppressor gene involved in regulating cell growth
  • Mutations in p16 that disrupt its function lead to unregulated cell growth
  • In the United States, p16 mutations are likely responsible for 1000-2000 new melanoma cases each year
  • p16 mutations account for the majority of known genetic causes of inherited melanoma cases

Cancer Risks

Melanoma and Pancreatic Cancer Risks


The risk for melanoma and pancreatic cancer is significantly increased in people with mutations in the p16 gene. p16 is a tumor suppressor gene and mutations disrupt the gene function and lead to unregulated cell growth.

 

 

Identifying Patients

Identifying Patients at Risk for Hereditary Melanoma


Finding patients who have germline mutations in the p16 gene and following up with them is a critical step in changing hereditary cancer outcomes. Genetic testing is available to identify patients who have germline mutations in the p16 gene and, consequently, an increased risk for melanoma and pancreatic cancer. The following “red flags” in a patient’s personal or family history are indicative of the presence of a p16 mutation and should help determine who should be tested:

  • Two or more melanomas in an individual or family
  • Melanoma and pancreatic cancer in an individual or family
  • Relatives of a p16 mutation carrier

Genetic testing also allows you to accurately identify patients at greater risk for melanoma, plan their medical management accordingly, and hopefully, prevent future cancers.

Click HERE to order complimentary patient materials that will help your patients better understand risks and medical management of hereditary melanoma. These materials inform patients about the cancer risks associated with the syndrome, and prompts them to ask the appropriate questions to uncover a pattern of hereditary melanoma in their family history.


*Assessment criteria based on medical society guidelines. For these individual medical society guidelines, go to www.myriadpro.com/guidelines

 

 

Benefits Of Testing

Benefits of MELARIS Testing


MELARIS genetic testing can help you to develop an effective road map for the medical management of patients with a p16 gene mutation, leading to a reduction in the risk and possible prevention of cancer.

A positive result with MELARIS genetic testing enables you to:

  • Target screening and surveillance only to those with the p16 gene mutation—maximizing patient care and increasing clinical efficiency
  • Counsel patients and family members on the underlying cause of a cancer
  • Avoid unnecessary interventions involving family members who did not test positive for the mutation

 

 

Medical Mangement

Managing Patients with Hereditary Melanoma Syndrome*


If the MELARIS® test shows an increased risk for melanoma and pancreatic cancer, the following medical management options may help reduce that risk.


Skin:

Increased Surveillance

  • Monthly self skin exams by patients beginning in childhood 75,81
  • Clinical full-body skin exams every 6 to 12 months, beginning at age 10 74,75,81,82
  • Baseline whole-body photography every 6 to 12 months beginning at age 10 76,82


Preventive Surgery

  • Immediate biopsy and/or removal of suspicious moles75,77,82
  • Lower threshold to biopsy of suspicious moles77,82


Preventive Lifestyle Adjustments

  • Limited exposure to the sun or ultraviolet radiation (e.g., tanning beds) 75,77, 82
  • Protective clothing, such as wide-brimmed hats, sunglasses, and long-sleeved shirts 75, 77,82
  • Application of sunscreen with a sun protection factor (SPF) of 15 or higher at regular intervals, especially in young children 75, 77,82


Pancreas:

Increased Surveillance

  • Consider endoscopic ultrasound (EUS), computed tomography (CT), or endoscopic retrograde cholangiopancreatography (ERCP) OR 78, 79, 80,82
  • Referral to research screening protocols

 

*Any discussion of medical management options is for general informational purposes only and does not constitute a recommendation.  While genetic testing and medical society guidelines provide important and useful information, medical management decisions should be made based on consultation between each patient and his or her healthcare provider.

 

 

Sample Test Results

Listed below are examples of the possible test results for MELARIS® genetic testing.

Comprehensive MELARIS p16 Analysis Result

Example of patient with no mutation detected

Comprehensive MELARIS p16 Analysis Result

Example of a patient positive for a p16 mutation

Comprehensive MELARIS p16 Analysis Result

Example of a patient positive for a genetic variant of uncertain significance in the p16 gene

Single Site MELARIS Analysis Result

Example of a patient negative for a specific mutation in the p16 gene

Single Site MELARIS Analysis Result

Example of a patient positive for a specific mutation in the p16 gene

 

 

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FAQ

MELARIS® Questions and Answers


How is the MELARIS test performed?

How long does it take for MELARIS test results?

Will a patient's health insurance cover the test?

Can a health insurance provider discriminate against a patient based on MELARIS results?



How is the MELARIS test performed?

A small amount of blood is drawn from the patient and sent to Myriad Genetic Laboratories, Inc. for DNA sequencing analysis.


How long does it take for MELARIS results?

Results usually take two weeks and are sent to the provider who ordered the test.


Will a patient's health insurance cover the test?

Most plans pay for MELARIS, with most patients paying less than 10% out of pocket.  If the patient's obligations for coinsurance or non-covered services exceed $375, Myriad will directly contact the patient within three business days of sample receipt to discuss options before performing the test.  Please note that the $375 limitation does not include any unmet deductibles, which are always the patient's obligation.


Can a health insurance provider discriminate against a patient based on MELARIS results?

Federal and state governments recognize the value of genetic information to patients and doctors and have put specific legal protections in place. The Genetic Information Nondiscrimination Act or GINA adds additional protection to existing legal protections that are in place at both the federal and state levels. GINA is a federal law that protects Americans from being treated unfairly based on differences in their DNA. GINA prevents discrimination from health insurers and employers. Health insurers are prohibited from requesting or requiring an individual or family member to undergo a genetic test or requesting, requiring, or purchasing genetic information, nor can they use an individual’s genetic information in setting eligibility, premium or contribution amounts by group and individual health insurers. GINA also protects individuals  from employers requesting, requiring, or purchasing genetic information about an individual employee or family member. In addition, the employer is prohibited from using an individual’s genetic information in employment decisions such as hiring, firing, job assignments and promotions.

The Health Insurance Portability & Accountability Act (HIPAA) recognizes genetic information as Protected Health Information (PHI) and specifies protecting its confidentiality. HIPAA further states that "genetic information shall not be treated as a pre-existing condition in the absence of a diagnosis of the condition related to such information," e.g., a diagnosis of hereditary cancer. The Americans with Disabilities Act (ADA) provides additional protections regarding the use of genetic information by employers.

Almost all states have additional laws that protect people from various forms of health insurance and employment discrimination based on genetic information. For more information about how these laws apply to you, go to the National Human Genome Research Institute at:
http://www.genome.gov/PolicyEthics/LegDatabase/pubMapSearch.cfm.