QUEBEC CITY, QC, Nov. 8 /PRNewswire-FirstCall/ - A new test for prostate cancer based on DiagnoCure’s PCA3 gene, which researchers believe is a much more precise indicator of prostate cancer than current diagnostics, has received CE Mark certification for use in Europe.
“I believe this is a significant moment for our company and for all those concerned with prostate cancer,” said John Schafer, President and Chief Executive Officer of DiagnoCure “We are confident that clinicians and patients will share our excitement at the potential of this important new prostate cancer diagnostic tool.”
The CE Mark opens the ways for commercialization of the test in Europe. The Gen-Probe PCA3 test, which measures the expression of the prostate cancer-specific gene, PCA3, will be formally launched later this month at the meeting of the British Association of Urologic Surgeons (BAUS) in the UK. Gen-Probe is conducting studies at seven leading European institutions to validate with European patients the expected high clinical utility of the test. Four molecular pathology laboratories across Europe are in the process of setting up the assay for the reporting of clinical results.
At a European symposium in October, attended by many of the world’s key opinion leaders in the management of prostate cancer, Dr. Jack Schalken’s keynote presentation discussed data suggesting the importance of PCA3 in predicting the outcome of a prostate biopsy. This is an issue of major concern in the diagnosis of prostate cancer, as up to 80% of patients with an elevated Prostate Specific Antigen (PSA) level may have a negative prostate biopsy. Being able to predict whether a second biopsy is needed could potentially spare many patients the uncomfortable experience of a second procedure. Dr. Frans Debruyne, Emeritus Professor of Urology at UMCN called PCA3 the most important discovery in his over 20-years as head of the department.
About DiagnoCure
DiagnoCure specialises in the development, production and commercialisation of diagnostic tests for the early detection of cancers. DiagnoCure’s first product, ImmunoCyt(TM) /uCyt+(TM), is an important tool for the diagnosis and monitoring of bladder cancer. In 2003, the Company granted an exclusive worldwide license for the use of the PCA3 technology in prostate cancer diagnosis to Gen-Probe. Tests based on the PCA3 gene, believed to be the most accurate indicator of prostate cancer, are currently available in Analyte Specific Reagent format (ASR) in the United States. DiagnoCure is now exploring additional applications for the early detection of lung and kidney cancer. DiagnoCure is headquartered in Quebec City, Canada. For more information, go to www.diagnocure.com.
Forward-looking statements
This release contains forward-looking statements that involve known and unknown risks, uncertainties and assumptions that may cause actual results to differ materially from those expected. By their very nature, forward-looking statements are based on expectations and hypothesis and also involve risks and uncertainties, known and unknown, many of which are beyond DiagnoCure’s control. As a result, investors are cautioned not to place undue reliance on these forward- looking statements. The forward-looking statements regarding the outcome of research and development projects and future revenues are based on management expectations. In addition, the reader is referred to the applicable general risks and uncertainties described in DiagnoCure’s most recent Annual Information Form under heading “Risk Factors”. DiagnoCure undertakes no obligation to publicly update or revise any forward-looking statements contained herein.
DIAGNOCURE INC.
CONTACT: Thom Skinner, Chief Financial Officer, DiagnoCure Inc., (418)527-6100, 1-888-900-6626, communications@diagnocure.com
