Frequently Asked Questions

What is deCODE ProCa ™?

deCODE ProCa™ 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. 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 ProCa™ 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 ProCa™ 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?

Patients without family history of prostate cancer may wish to know their genetic risk. 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 ProCa™ 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 test and physical examination of the prostate.Back to top of page

Is deCODE ProCa™  an FDA approved test?

No, deCODE ProCa™  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 ProCa™ 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 ProCa ™, 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 ProCa ™ following the simple steps outlined in Ordering deCODE ProCa™.

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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 ProCa™ as widely available as possible and is working with physicians, patients, and their insurers on reimbursement for deCODE ProCa™. 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 ProCa ™, 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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