Partners in search of a prognosis
OXFORDSHIRE, U.K.óOxford Gene Technology (OGT), which specializes in genetics research and biomarker solutions, has been granted a license by the Institute of Cancer Research (ICR) of London to further develop and commercialize a new panel of diagnostic and prognostic microRNA biomarkers for prostate cancer. The agreement follows a three-year collaboration between OGT and the ICR resulting in the joint discovery of the microRNA biomarkers, which the partners believe have wide-ranging potential applications in diagnosis, prognosis, treatment planning and patient monitoring.
"The collaboration between OGT and the ICR is a perfect example of how academia and industry can work together to translate laboratory research into a diagnostic test with clinical utility," says OGT CEO Dr. Mike Evans. "ICR brings world-renowned scientific and clinical expertise plus access to high-quality, highly annotated samples, while OGT provides the significant resources and experience required to rapidly validate and commercialize the resulting test. Regular project steering meetings have ensured that the development work has been carried out on time and to the highest scientific standards, while independent statistical analyses have confirmed robust, reliable data."
Currently, the biomarker prostate-specific antigen (PSA) and a digital rectal examination are used to test for prostate cancer and to determine whether a biopsy is required. However, increasing evidence indicates that PSA may not be an effective screening tool for prostate cancer due to a high false positive rate and an inability to distinguish between more aggressive and indolent cancers. Prostate cancer encompasses a number of cancers types, the most common of which is adenocarcinoma (glandular cancer), which generally originates in the semen-secreting cells of the peripheral zone of the prostate gland. There are many biomarkers for prostate cancer, including PSA, PCA3 (Prostate Cancer 3) and Early Prostate Cancer Antigen-2 (EPCA-2). However, none of these biomarkers have been shown to be highly sensitive and specific in a clinical setting, and only PSA has been approved for clinical use in the United States.
"Apparent incidence is greatest in those regions where prostate cancer screening programs are deployed," Evans notes. "Such programs are typically based on the PSA and PCA3 tests that diagnose cancer but do not differentiate between aggressive or indolent forms. As such, mortality rates remain fairly consistent in all populations regardless of the implementation of screening programs. The advantage of OGT's test lies in the capability to detect aggressive prostate cancer, allowing appropriate medical intervention."
Unlike the present screening techniques, the biomarkers discovered by OGT and the ICR have a high sensitivity and specificity of more than 90 percent, plus the potential to not only identify prostate cancer, but also to assess its aggressiveness. This is important, as it will allow treatment to be tailored to specific features of the cancer. At present, a diagnosis of prostate cancer can mean removal of the prostate and chemotherapy; patients with indolent cancer often receive, but do not require, such excessive treatment.
Colin Cooper, professor of cancer genetics at the University of East Anglia, who led the study at the ICR, says, "OGT and the ICR have made significant progress. Prostate cancer is the most common type of cancer in men, with over 240,000 new cases diagnosed each year in the U.S. alone; we need to focus our efforts not only on ensuring accurate diagnosis, but also individualized treatment tailored by prognosis."
In addition to further validation of the biomarker panel in tissue samples, OGT is evaluating the panel in both blood and urine samples.
"OGT has a clear product development and commercialization strategy to bring this improved diagnostic test to market," Evans says. "We are currently translating the assay to a blood-based PCR test, which is showing very encouraging results. Following further tests and clinical validation, the test will be offered through an OGT CLIA-approved laboratory."