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Test to be commercialized by Proactive Genomics, LLC

In the past few years, novel research tools have emerged which scientist to systematically and objectively evaluate genetic variants in the genome. These new techniques have improved researchers’ ability to identify risk variants in the genome that account for genetic susceptibility to many common cancers.

A recent study led by researchers at Johns Hopkins, Wake Forest and the Karolinska Institute in Sweden, has identified an array of gene markers for hereditary prostate cancer that, along with family history for the disease, appear to raise the risk of prostate cancer by more than nine times that of men without such markers.

Data gleaned from a study of more than 4,000 Swedes found that these markers are common and could account for nearly half of the prostate cancer cases in the study. Five independent genetic variants were identified and associated with the increased prostate cancer risk.

Researchers found that the combined effect of these genetic markers was a much better predictor of prostate cancer risk: men who had more of the genetic risk variants and a positive family history had a higher risk of developing prostate cancer compared to men that did not have any of the risk factors.

Men who had any combination of 3, 4, and 5 of the risk factors had a 2.7, 4.8, and 9.5 fold increased risk (respectively).

The consistent, strong associations of these common risk variants suggest that these five genetic variants can be used to predict individual prostate cancer risk in the general population.

In the next few months, the test will be made available by Proactive Genomics, LLC using saliva or blood samples. The test will be sold under the Focus5 Prostate Cancer Risk Test brand.

Dr. Xu, Associate Director of the Center for Human Genomics at Wake Forest and a co-founder of Proactive Genomics, plans to offer the test now because, “We believe that some men and their physicians will want to take advantage of these findings – knowing that the test will be refined over time as additional risk variants are discovered.”

Xu believes the genetic testing can be further improved, by incorporating additional risk variants that will be identified in the coming months and clinical information such as the Prostate Specific Antigen Test (PSA). In addition, further research will help determine which men can benefit most from the test.

In a statement Xu commented, “It is premature to make specific recommendations on who should get the test, but we believe it may be a benefit to men over 50 years of age, and may be especially beneficial to men who have marginally elevated PSA levels and men who have a family history of prostate cancer.”

Results described in the published report were from Swedish men only. Independent of the published report, researchers have confirmed results in follow-up studies of European American men and African American men; investigators report that more studies are needed, particularly in African Americans and other races and ethnicities.