Novel Genetic Risk Assessment Test for Prostate Cancer

An inexpensive, accurate and non-invasive one-step genetic test that screens for risk of prostate cancer. The test outperforms family history and blood tests as predictors of cancer risk and provides early assessment of the predisposition to prostate cancers.

Problem

Proactive screening to identify asymptomatic cancer at an early and treatable stage is a critical first step in preventing prostate cancer. The American Cancer Society recommends that men begin discussing screening options with their health care provider as early as age 40 or 50, depending on their level of risk. Current screening guidelines are informed largely by a combination of patient family history, prostate specific antigen levels and a digital rectal exam. Genetic risk assessment tests are offered only to individuals with a strong family history of disease. As such, current practices may not provide sufficient early detection and diagnosis for patients at risk. There is a need for earlier, simpler, affordable and more effective screening methods for prostate cancer.

Solution

Researchers at Wake Forest Baptist Medical Center have developed a simple, non-invasive screening tool that measures the risk and aggressiveness of prostate cancer. The multi-SNP (single nucleotide polymorphisms) panel can be administered quickly in the primary care setting and identifies DNA SNPs in patient samples of blood or saliva. These are powerful genetic markers that, together with family history, are estimated correlate with over 36% of the cases of prostate cancer. Additionally, this test is independent of serum prostate specific antigen levels. Since serum prostate specific antigen levels are indicated only for older high-risk males, this test creates new opportunities to pre-screen at-risk individuals.

The test generates a personalized genetic risk score from a simple blood draw that predicts a patient’s likelihood of developing prostate cancer. This one-step simple test outperforms tests based on prostate specific antigen levels and family history. The test kit includes a microarray chip containing the known cancer risk-associated SNPs, a software package to calculate the genetic risk score for each cancer from genotype and a visual aid for physicians and patients to facilitate the interpretation and understanding of results.

Competitive Benefits

  • Inexpensive, rapid and convenient, requiring a simple blood draw
  • Direct accurate measurement of individual risk is especially informative for individuals without a known family history outperforms family history and prostate specific antigen testing as a predictor of cancer risk
  • Potential to reduce risks associated with under/over-screening and unnecessary biopsy
  • Detects cancer at an earlier and more treatable stage
  • Informs clinicians about cancer aggressiveness and the need for early prostate specific antigen screening, prostate biopsy and/or chemoprevention
  • May have a significant impact on the 1 in 6 men in the U.S. who will be diagnosed with prostate cancer in their lifetime

Application Fields

Primary care preventative cancer screening, clinical decision-making tool to assess need for biopsy in prostrate cancer

Stage of Development

This technology is available for CLIA approval as a laboratory-developed test and for clinical testing as an in vitro diagnostic

Inventor

Jianfeng Xu, PhD, Center for Personalized Medicine, Northshore University Health System, Formerly at Wake Forest Baptist Medical Center

Keywords

Prostate cancer, single-nucleotide polymorphisms (SNP), personalized medicine, genetic risk score, preventative cancer screening, pre-biopsy, clinical decision-making tool

Patent Status

Issued patents: 7,718,372, 7,993,843, 7,579,147
Pending Applications: US 12/339,653, US 13/344, 907, US 13/818,602, EPO 11822720.6 (allowed), US 14/444,945, US 14/775,969, US 14/883,188, US15/202,119

Publications

Xu J, et al. Germline mutations. Nat Genet. 2002 Oct;32(2):321-5
Cramer SD, et al. Genetic polymorphisms. J Natl Cancer Inst. 2003 Jul 16;95(14):1044-53
Zheng SL, et al. Cumulative association of five genetic variants with prostate cancer. N Engl J Med. 2008 Feb 28;358(9):910-9
Sun J, et al. Evidence for two independent prostate cancer risk-associated loci. Nat Genet. 2008 Oct;40(10):1153-5
Zheng SL, et al. Genetic variants and family history predict prostate cancer. Clin Cancer Res. 2009 Feb 1;15(3):1105-11
Xu J, et al. Prostate cancer risk associated loci in African Americans. Cancer Epidemiol Biomarkers Prev. 2009 Jul;18(7):2145-9
Xu J,et al. Estimation of absolute risk. Prostate. 2009 Oct 1;69(14):1565-72
Xu J, et al. Inherited genetic variant. Proc Natl Acad Sci U S A. 2010 Feb 2;107(5):2136-40
Kader AK, et al. Potential impact of adding genetic markers. Eur Urol. 2012 Dec;62(6):953-61
Chen H, et al. Adding genetic risk score. Prostate. 2016 Sep;76(12):1120-9
Conran CA, et al. Population-standardized genetic risk score. Asian J Androl. 2016 Jul-Aug;18(4):520-4
Liu W, et al. Genetic markers. Cancer. 2013 Jul 1;119(13):2405-12
Xu J. Xu’s chart for prostate biopsy. Asian J Androl. 2014 Jul-Aug;16(4):536-40

Licensing Contact

Peter Golikov, MS, MBA, CLP
Licensing Director, Center for Technology Innovation & Commercialization
pgolikov@wakehealth.edu
+1.336.713.1664

Ref #: WFU 02-23, 04-04, 08-22, 10-03, 11-01, 13-73, 14-32, 14-94

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