COLARIS AP® FAQ
COLARIS AP® Questions and Answers
MYH and COLARIS APPLUS Testing FAQs
A small amount of blood is drawn from the patient and sent to Myriad Genetic Laboratories, Inc. for DNA sequencing analysis of the APC and MYH genes. COLARIS AP can also detect large rearrangements in the APC gene that will not be identified by gene sequencing.
Results take up to 21 days after insurance approval and are sent to the provider identified as "mail to" on the Test Request Form.
Most health insurance plans pay for COLARIS AP. Patients typically pay co-insurance of less than 10% of the test price. Myriad will notify you before processing your test if you total financial responsibility exceeds $375 (or $15 per month when utilizing our interest-free 25-month payment plan) for any reason, including co-insurance, deductible, or non-covered services. Call Myriad at 800-469-7423 for more details.
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:
Individuals with an APC mutation are at a greater risk for developing a new cancer - even extracolonic cancer following a prophylactic colectomy. Knowing a patient's genetic status can help reduce this risk or detect another potential cancer at an earlier, more treatable stage. Importantly, a patient's test results also have significant meaning for the health of his or her family members, especially since FAP is characterized by juvenile onset. In addition, patients clinically diagnosed with FAP or AFAP may have mutations in their MYH genes, leading to a condition called MAP, which presents different risks to family members. Genetic testing cane help distinguish between MAP and FAP/AFAP in certain families.
COLARISPLUS and COLARIS APPLUS are Comprehensive COLARIS and Comprehensive COLARIS AP plus MYH full sequencing and large rearrangements.
No. There will be no price increase with the MYH enhancement.
No. Coverage for the COLARISPLUS and COLARIS APPLUS tests with MYH enhancements will be equivalent to the current coverage.
The process for Medicare submissions will not change for COLARISPLUS and COLARIS APPLUS. MYH will be run concurrently with MLH1, MSH2, MSH6, and EPCAM. PMS2 will continue to be run as a reflex test.
All Comprehensive COLARIS and Comprehensive COLARIS AP orders received on or after February 6, 2013 will automatically include MYH analysis.
Medical society management recommendations for MAP include colonoscopies every 1-2 years starting at age 25-30, upper endoscopies every 3-5 years starting at age 30-35, and surgical considerations. The most appropriate medical management will vary based upon your patient’s clinical presentation. For medical management references, visit www.MyriadPro.com/References.
Medical management should be determined by clinicalfindings and personal and family history of colorectal polyps and/or cancer. Current data are limited but suggest that any increase in risk, if present, is likely to be small (N Engl J Med 2003;348:791-799; Lancet 2003;362:39-41; J Natl Cancer Inst 2004;96:1631-1634).
MYH analysis should be ordered for previously tested patients at the discretion of the healthcare provider. To order MYH analysis for previously tested patients, write in "MYH analysis" in the "other" section of the COLARIS or COLARIS AP Test Request Form (TRF). MYH analysis test orders for previously tested patients will follow our normal customer service process. The cost of MYH analysis when ordered independently is $1,340.
No. COLARISPLUS and COLARIS APPLUS will still be reported up to 21 days after insurance approval.
Test kits shipped after late February 2013 will contain new TRFs. However, Myriad will automatically include MYH analysis on all Comprehensive COLARIS or Comprehensive COLARIS AP orders processed on or after February 6, 2013.
Similar to PMS2 analysis, MYH analysis will be reported on a separate page, in the same packet as COLARIS results report. MYH will be reported on the same report for COLARIS APPLUS results.
No. MYH analysis will only be processed and reported once if both COLARISPLUS and COLARIS APPLUS testing are ordered, or if MYH gene analysis has been completed in the past.