Novel diagnostic and prognostic markers for prostate cancer using
methylated DNA.
Technical Field
Biotech, Pharma
Business opportunity
Research collaboration to validate the
technology
Current state of technology
Methylation-sensitive qPCR (MS-qPCR) assays have been developed and
tested in ~500 clinical samples from prostate cancer patients with ~5-years
follow-up information; Available in our own biobank (FFPE tissue) and from
international collaborators (FFPE/FF).
Commercial Value
The biomarker market is still in a early development phase. There are
approximately 10 products on the European market and revenues in 2008 reached
$666.3 million. However, growth is expected ? Frost & Sullivan estimate a
13.5% CAGR towards 2015, although the market is challenged by the
recession.
There is a clear clinical unmet need related to diagnosis and
monitoring of prostate cancer patients. The current standard is the PSA test.
The most widely used biomarker among researchers in prostate cancer is PSA.
Despite many attempts by drug companies in the past to validate PSA data, the
FDA has so far rejected changes in PSA as a surrogate endpoint in clinical
trials. Moreover, PSA has received criticism from critics that blame it for the
overdiagnosis and overtreatment of millions of patients since the
90s.
The Technology
Due to insufficiency, additional biomarkers are needed in prostate
cancer that can increase the specificity and sensitivity of prostate cancer
diagnostics and predict the rate of disease progression of prostate cancer as
well as the response to particular interventions.
The present invention relates to 8 genes that can be used as
biomarkers for prostate cancer. The inventors have shown that the 6 identified
genes are targets for promoter hypermethylation in prostate cancer, and can be
used as diagnostic/prognostic/predictive biomarkers for prostate cancer. The
inventions cover various aspects of the genes in which hypermethylation the
promoter region is used as a biomarker. Based on PCR methods, the technology
enables more cost-effective, safe individualized treatment of prostate cancer
patients and help reduce unnecessary side-effects from over-treatment of
low-risk patients and/or under-treatment of high-risk prostate patients. The
invention is of potential in the clinical management of prostate cancer patients
in hospitals worldwide.
Intellectual Property Rights
Aarhus University has filed a patent application in the US, with
priority date Sep 2011 and this has proceeded through the PCT
phase.