Partners in search of a prognosis

OXFORDSHIRE, U.K.—Oxford Gene Technology (OGT), whichspecializes in genetics research and biomarker solutions, has been granted alicense by the Institute of Cancer Research (ICR) of London to further developand commercialize a new panel of diagnostic and prognostic microRNA biomarkersfor prostate cancer. The agreement follows a three-year collaboration between OGTand the ICR resulting in the joint discovery of the microRNA biomarkers, whichthe partners believe have wide-ranging potential applications in diagnosis,prognosis, treatment planning and patient monitoring.

"The collaboration between OGT and the ICR is a perfectexample of how academia and industry can work together to translate laboratoryresearch into a diagnostic test with clinical utility," says OGT CEO Dr. MikeEvans. "ICR brings world-renowned scientific and clinical expertise plus accessto high-quality, highly annotated samples, while OGT provides the significantresources and experience required to rapidly validate and commercialize theresulting test. Regular project steering meetings have ensured that thedevelopment work has been carried out on time and to the highest scientificstandards, while independent statistical analyses have confirmed robust,reliable data."

Currently, the biomarker prostate-specific antigen (PSA) anda digital rectal examination are used to test for prostate cancer and todetermine whether a biopsy is required. However, increasing evidence indicatesthat PSA may not be an effective screening tool for prostate cancer due to ahigh false positive rate and an inability to distinguish between moreaggressive and indolent cancers. Prostate cancer encompasses a number ofcancers types, the most common of which is adenocarcinoma (glandular cancer),which generally originates in the semen-secreting cells of the peripheral zoneof the prostate gland. There are many biomarkers for prostate cancer, includingPSA, PCA3 (Prostate Cancer 3) and Early Prostate Cancer Antigen-2 (EPCA-2).However, none of these biomarkers have been shown to be highly sensitive andspecific in a clinical setting, and only PSA has been approved for clinical usein the United States.

"Apparent incidence is greatest in those regions whereprostate cancer screening programs are deployed," Evans notes. "Such programsare typically based on the PSA and PCA3 tests that diagnose cancer but do notdifferentiate between aggressive or indolent forms. As such, mortality ratesremain fairly consistent in all populations regardless of the implementation ofscreening programs. The advantage of OGT's test lies in the capability todetect aggressive prostate cancer, allowing appropriate medical intervention."

Unlike the present screening techniques, the biomarkersdiscovered by OGT and the ICR have a high sensitivity and specificity of morethan 90 percent, plus the potential to not only identify prostate cancer, but alsoto assess its aggressiveness. This is important, as it will allow treatment tobe tailored to specific features of the cancer. At present, a diagnosis ofprostate cancer can mean removal of the prostate and chemotherapy; patientswith indolent cancer often receive, but do not require, such excessivetreatment.

Colin Cooper, professor of cancer genetics at the Universityof East Anglia, who led the study at the ICR, says, "OGT and the ICR have madesignificant 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 tofocus our efforts not only on ensuring accurate diagnosis, but alsoindividualized treatment tailored by prognosis."

In addition to further validation of the biomarker panel intissue samples, OGT is evaluating the panel in both blood and urine samples.

"OGT has a clear product development and commercializationstrategy to bring this improved diagnostic test to market," Evans says. "We arecurrently translating the assay to a blood-based PCR test, which is showingvery encouraging results. Following further tests and clinical validation, thetest will be offered through an OGT CLIA-approved laboratory."