Frequently Asked Questions

What is deCODE ProstateCancer ™?

deCODE ProstateCancer™ is a reference laboratory DNA test for assessing an inherited risk factors for prostate cancer, a major cancer affecting males worldwide. The test detects versions of markers called SNPs (single nucleotide polymorphisms) – a one letter variation in the sequence of the genome, more specifically on chromosome 2, 8, 11, 17 and the X chromosome - that deCODE and others have linked to an increased risk for prostate cancer. Based on these 8 known gene markers, the test can define risks in Europeans of European ancestry ranging from 0.33 to 17 compared to that of the general population. Caution needs to be taken in applying extremely high risk results to individuals. For example, genotype combinations promoting combined relative genetic risk over 5.0 are extremely rare (about 1 in 10,000). For this reason the highest reported combined genetic risk result is limited to 5.0, equivalent to a lifetime risk of 80%.Back to top of page

What is this test based on?

The test is based on the results of four deCODE studies, all published in Nature Genetics, in June 2006 (http://www.nature.com/ng/journal/v38/n6/pdf/ng1808.pdf), in May 2007 (http://www.nature.com/ng/journal/v39/n5/pdf/ng1999.pdf), in August 2007 (http://www.nature.com/ng/journal/v39/n8/pdf/ng2062.pdf) and most recently in the 10th of February 2008 on-line edition of Nature genetics. Additionally included is a marker on chromosome 11 also published on the same day, February 10th in the on-line edition of Nature genetics by G. Thomas et. al.

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What is a genetic risk factor for a common disease and why is understanding inherited risk important?

A genetic risk factor for a common disease is a specific version of a marker in the sequence of the genome that correlates with an increased likelihood of developing a given disease. Common diseases such as prostate cancer occur at the interface of genes and the environment, as inherited as well as environmental 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, or effectively manage the consequences of the disease.

In basic terms, carrying a genetic risk variant 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 getting 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 with potentially important clinical utility. By understanding inherited risk, it may be possible to take preventive action against prostate cancer– through regular screening.


In basic terms, carrying a genetic risk variant 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 getting 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 with potentially important clinical utility. By understanding inherited risk, it may be possible to take preventive action – through lifestyle modification or by taking certain medications, in general taking the preventive measures necessary to minimize the effects of the disease and maximize the chances of staying healthier longer.

 

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Should test results be interpreted differently for different ethnic groups?

The results are at this time only applicable to white European males since research data are not currently available for other ethnicities for all the variants.

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Why is understanding genetic risk important for prostate cancer?

The discovery of prostate cancer genes provides a method of detection for genetic predisposition for the disease independent of the family history. the deCODE ProstateCancer™ test is capable of identifying those who are at highest risk for developing prostate cancer based on the 8 known genes for prostate cancer. In light of the excellent survival rate when diagnosed early, the deCODE ProstateCancer™ test may be of value for identifying patients who are at a higher risk of prostate cancer and should have earlier and more frequent screening for early detection.

 

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Who might benefit from having this test and why?

he American Urological Association (AUA) recommends that men 40 years of age or older should be offered a risk assessment and early detection for prostate cancer and men who wish to be screened should have both a prostate-specific antigen (PSA) test and a digital rectal exam (DRE). The AUA believes that a risk assessment at the age of 40, including a base line PSA measurement is of value for a more cost effective prostate cancer screening and prevention. Also the AUA is of the opinion that the decision to proceed to prostate biopsy should be based not only on PSA and DRE results, but should take into account multiple factors including free and total PSA, patient age, PSA velocity, PSA density, family history, ethnicity, prior biopsy history and comorbidities. (http://www.auanet.org/content/guidelines-and-quality-care/policy-statements/e/early-detection-of-prostate-cancer.cfm
http://www.auanet.org/content/guidelines-and-quality-care/clinical-guidelines/main-reports/psa09.pdf ).

The American Cancer Society recommends that screening should be offered to all men 50 years and older, and as early as age 40 for men with more than 1 risk factor. Screening should include, for those who elect to undergo screening, a yearly digital rectal exam and a prostate specific antigen (PSA) blood-test at the minimum. (http://www.cancer.org/docroot/CRI/content/CRI_2_4_3X_Can_prostate_cancer_be_found_early_36.asp?sitearea=)

The deCODEme ProstateCancer™ test results can have a significant effect on men's overall risk fro prostate cancer and is an important part of a baseline risk assessment for deciding on the frequency and extent of screening for those men who choose to be regularly screened. Especially, deCODEme ProstateCancer™ may be useful for the identification of those who should have a more closer and frequent screening exams, even in the absence of the well known risk factors such as family history or ethnicity. Patients who are already at higher risk based on other factors such as family history may wish to further refine their risk with the deCODE ProstateCancer™ genetic profile. Individuals with higher genetic risk for prostate cancer may benefit from earlier and more regular monitoring by a physician of the prostate, including the prostate specific antigen tests and physical examination of the prostate. Also deCODEme ProstateCancer™ may be used along with other factors in the decision making on when to proceed to prostate biopsy.

Certain genotype combinations of two of the SNPs included in the deCODEme ProstateCancer™ test (rs2710646 and rs1447295) predict a more aggressive and advanced form of the cancer at the time of diagnosis. Aggressiveness of prostate cancer is traditionally classified according to the TNM scoring system and histological grade based on the Gleason score. Being homozygous for the risk alleles (AA) at either or both of the aforementioned SNPs or being heterozygous (A) for the risk alleles at both loci or even only rs1447295, carries an increased relative risk of 1.1 to 1.58 for a T-score of 3-4 and/or N+ and/or M+ and/or Gleason score of 7-10. In general about 40% of all prostate cancers are of these grades at the time of diagnosis.

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Is deCODE ProstateCancer™  an FDA approved test?

No, deCODE ProstateCancer™  is a reference laboratory test that has not been cleared or approved by FDA. The laboratory that conducts the test is registered as a high-complexity laboratory under the Clinical Laboratory Improvement Amendments (CLIA). The clinical utility of this test as a means of assessing inherited susceptibility to prostate cancer, as presented on this site and elsewhere, is based upon published studies by deCODE and independent researchers demonstrating the correlation of carrying at-risk deCODE ProstateCancer™ genotypes and increased likelihood of prostate cancer.

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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 has published its discoveries of variants on chromosomes 2, 8, 11, 17 and on the X-chromosome associating with increased risk of prostate cancer in Nature Genetics in June 2006, May 2007, August 2007 and February 2008.  These discoveries have been replicated and extended in several published studies by other excellent  researchers.

 

For a complete list of relevant publications, click here.


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What is a positive result?

An individual with two copies of the risk variants will receive a positive result for deCODE ProstateCancer ™, and those with only one or no copy of the risk variants will receive a negative result for the test.

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How can I order the test?

You can have any licensed physician order your deCODE ProstateCancer ™ following the simple steps outlined in Ordering deCODE ProstateCancer™.

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

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How can I get additional information?
If you would like additional information on deCODE ProstateCancer ™, you can 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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