Frequently Asked Questions

 

What is deCODE AF™?
deCODE AF™ is a DNA-based that detects versions of two common single-letter variations in the genome (also known as SNPs) near the PITX2 gene on chromosome 4 that deCODE has identified as major risk factors for atrial fibrillation (AF).

What is a reference laboratory test?
deCODE AF™ is a reference laboratory test, which means that a sample is sent to our laboratory for analysis. The test itself is not performed in a doctor’s office.

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Who can order the test?
deCODE AF™ can only be ordered with the written informed consent of the individual being tested and accompanied by the authorization of a qualified physician.

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How does the testing process work?
The testing process involves a few simple steps. First, and very importantly, the person who is being tested must give his/her signed, informed consent for the test to be ordered. That means that an individual and his/her doctor need to review the informed consent form that explains what the test is for and what the results may mean. The person being tested must also have the opportunity to have any questions they may have answered to their satisfaction before deciding whether or not they wish to be tested. Once the individual has signed the informed consent, his/her doctor will need to collect a testing sample, most likely a small tube of blood, which is then sent to deCODE for analysis. deCODE will make all reasonable efforts to produce a report within 2-3 weeks from the time a sample is submitted, and the authorizing physician will then report the results to the individual and explain what they mean and how they may be used to facilitate the best possible treatment.

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What does a positive result mean?
It is important to bear in mind that common diseases, such as atrial fibrillation and stroke, occur as a result of the interplay of both environmental (including lifestyle and other health and medical conditions) and inherited risk factors. As a result, having a specific genetic risk factor for a common disease does not mean that one will necessarily develop the disease; and not having a certain risk variant does not eliminate the possibility of developing the disease. Rather, in the common diseases, genetic risk variants impact the likelihood that one may develop a given condition.

The deCODE AF test measures the at-risk versions of the two SNPs linked by deCODE to risk of AF. Approximately 30% of those of European ancestry in deCODE’s studies are positive for the deCODE AF™ test, corresponding to an average 2-fold increase in likelihood of AF compared to those negative for the test. The increase in risk is modestly higher for lone AF (that is, AF without known structural or hormonal risk factors).

deCODE believes that because of the correlation between these variants and increased risk of AF, individuals who have suffered either a stroke or aTIA might benefit from having the test. Those who are positive for the test, and thus at a higher than average likelihood of having AF, might benefit from outpatient cardiac monitoring that can detect AF. Current best clinical practice recommends that those stroke patients with AF receive warfarin therapy to minimize the risk of another stroke.

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What does a negative result mean?
It is very important to realize that because there are a number of risk factors of atrial fibrillation, including both genetic and lifestyle/health factors, receiving a negative result for the deCODE AF™ test does not mean that one is at low or no risk of AF.

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Should test results be interpreted differently for different ethnic groups?

Yes. At present we have established association of these two SNP markers to AF in large cohorts of European origin and in a cohort of Han Chinese. We expect that the publication of our findings will help to accelerate the analysis of the impact of these markers in additional populations.

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Will anyone else know the results of my test?

deCODE takes your privacy seriously, and our testing process is designed to ensure that it is the individual being tested who designates those to whom the results will be reported. deCODE will report results only to the physician(s) and/or healthcare institution(s) specified on the test request form and as confirmed by the individual in his/her informed consent.

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What is a genetic risk factor for a common disease and why is understanding genetic risk important in a condition such as AF or stroke?
A genetic risk factor for a common disease is a specific version of a marker in the sequence of the genome that causes or correlates with an increased likelihood of developing a given disease. Common diseases such as AF and stroke tend to occur at the interface of genes and the environment, as both inherited as well as lifestyle and other health risk factors play important roles in the disease process. As a result, it is important to understand what carrying an inherited risk variant for a common disease means, and how that information can be used to develop and implement disease prevention strategies that can effectively reduce the likelihood of an individual ever developing the disease.

In basic terms, carrying a genetic risk variant for a common disease does not mean that one will develop the disease; and not having a certain risk variant does not eliminate the possibility of developing the disease. Rather, for the common diseases, genetic risk variants impact the likelihood that one may develop the disease. Understanding this inherited risk is empowering information* that provides the opportunity to detect and address a risk factor that may not otherwise be found or treated. A positive result for the deCODE AF™ test means that an individual carries genetic variants that confer a predisposition to AF.

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Who might benefit from this test?
 Patients with history of ischemic stroke or TIA who are not already known to have AF may be tested to help decide which patients are at highest risk for undiagnosed AF and who may benefit the most from more extensive ambulatory cardiac monitoring.The test can only be ordered by a physician and is not for screening the general population.

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What scientific publications support the value of this test?
deCODE is widely recognized as the world leader in the discovery of genes contributing to risk of common diseases. deCODE has also led the way in publishing its discoveries, a commitment that not only drives ongoing research but also enables independent researchers from around the globe to validate the company’s discoveries.

deCODE’s discovery of variants on chromosome 4q25 was published in the scientific journal Nature in July 2007 (E-pub ahead of print): Variants conferring risk of atrial fibrillation on chromosome 4q25.
Please note that the article can be found under "Letters" in Nature's "Advance online publication" (see link above)).(E-pub ahead of print).


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Is decode AF™ FDA approved?
Q&A No The deCODE AF™ is not FDA approved.

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Payment and Reimbursement?
Payment can be made by any major credit card by the individual or by the ordering physician or clinic, by including the card details on the test request form. Samples submitted anonymously must be accompanied by a valid credit card number from the respective doctor or affiliated health care institution.

deCODE plans to make the deCODE AF™ as widely available as possible and is working with physicians, patients, and their insurers on reimbursement for deCODE AF™. For more information contact customer service at diagnostics@decode.com, or by phone at 1-877-222-6510

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Who can I contact if I have further questions?
deCODE offers this test via physician so that individuals will understand what the test is for, what the results mean, and to integrate the testing process into an effective treatment regime following stroke or TIA. However if you have additional questions regarding the test, please contact deCODE at diagnostics@decode.com, or by phone at 1-877-222-6510 and a deCODE representative will respond promptly to your questions.

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