Lynch Syndrome Testing—Questions and Answers
How is the COLARIS® test performed?
There are now two ways to obtain a sample from the patient for analysis. A small amount of blood can be drawn, or an oral sample can be taken using a buccal rinse. A sample is sent to Myriad Genetic Laboratories for DNA sequencing analysis of MLH1, MSH2, and MSH6. COLARIS can also detect large rearrangements in MLH1 and MSH2 that will not be identified by gene sequencing.
How long does it take for COLARIS test results?
Results usually take 2 weeks and are sent to the ordering healthcare provider, or to a designated "mail to" provider identified on the test request form.
Will a patient’s health insurance cover the test?
Most plans pay for COLARIS, 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 3 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 COLARIS 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.
If a patient has already been diagnosed with cancer, what does a positive COLARIS result indicate?
Individuals with Lynch syndrome gene mutations are at greater risk for developing a new cancer, in either the colon, endometrium, or other areas. Knowing a patient’s genetic status can help reduce this risk or detect another potential cancer at an early, more treatable stage. Importantly, a patient’s test results also have significant meaning for the health of his or her family members.
