NEW U.S. PATENT GRANTED FOR DIAGNOCURE'S PCA3 PROSTATE CANCER BIOMARKER
-20-month extension of the Gen-Probe license-
QUEBEC CITY, June 15, 2011 /PRNewswire/ - DiagnoCure, Inc. (TSX: CUR), a life sciences company commercializing high‐value cancer diagnostic tests and delivering laboratory services, today reported the issuance of a new U.S. patent, which represents a significant addition to DiagnoCure's PCA3 prostate cancer biomarker portfolio. Moreover, in addition to providing greater patent protection, this new patent bears an extended expiration date that lengthens by 20 months the term of the license that DiagnoCure granted to its commercial partner, Gen-Probe.
This new U.S. patent, 7,960,109 "mRNA Ratios in Urinary Sediments and/or Urine as a Prognostic and/or Theranostic Marker for Prostate Cancer", covers the particularities of the quantitative urinary test developed by Gen-Probe. This test allows the determination of a PCA3 score in urine following a digital rectal examination, and indicates the probability of finding cancer in a prostate biopsy by associating a higher score with a greater probability of a positive biopsy, with a much greater precision than the traditional PSA test.
The term of the license agreement with Gen-Probe is tied to the last-to-expire licensed patents. An adjustment of 602 days (20 months) beyond the usual 20-year patent term has been allowed by the United States Patent and Trademark Office (USPTO) on the US patent 7,960,109, due to the length of time the USPTO took to issue the patent. As a result, since this is now the patent with the latest expiration date, the duration of the Gen-Probe license will be extended to August 2027.
About Prostate Cancer and PCA3
According to the American Cancer Society (ACS) and the Canadian Cancer Society (CCS), prostate cancer is the second most common type of cancer found in North American men (behind skin cancer), and the second-leading cause of cancer death in men (after lung cancer). One in six North American men will get prostate cancer during his lifetime, and one in 36 will die from it. The ACS and CCS estimate that about 242,000 North Americans will be newly diagnosed with prostate cancer in 2010, and that approximately 36,000 men will die from the disease.
PCA3 is a gene that is highly over-expressed in more than 90% of prostate cancers, and that can be quantified in urine specimens following a digital rectal examination. Studies have shown that because PCA3 is highly specific for prostate cancer, it predicts the results of repeat biopsies more accurately than traditional prostate-specific antigen (PSA) testing.
Data from approximately 50 peer-reviewed publications suggest that PCA3 testing, when used with other patient information, may help address some of the well-known challenges urologists face when identifying prostate cancer, such as identifying clinically relevant cancers that need to be treated, while minimizing unnecessary biopsies. Moreover, a recent European study suggested that PCA3 testing also could predict the outcome of initial biopsies in men suspected of having prostate cancer.
DiagnoCure (TSX: CUR) is a life sciences company commercializing high-value cancer diagnostic tests and delivering laboratory services that increase clinician and patient confidence in making critical treatment decisions. DiagnoCure Oncology Laboratories, a subsidiary of DiagnoCure, Inc., launched in 2008 the PrevistageTM GCC Colorectal Cancer Staging Test, the first GCC-based molecular test for the management of colorectal cancer. To date, two major studies (JAMA 2009 and Ann. Surg. Onc. 2011) have demonstrated that the GCC biomarker, to which DiagnoCure owns exclusive worldwide diagnostic rights, of all the risk factors compared in the studies is the strongest independent predictor of colorectal cancer recurrence. The Company has a strategic alliance with Gen-Probe (NASDAQ: GPRO) for the development and commercialization of a second-generation prostate cancer test using PCA3, DiagnoCure's proprietary molecular marker. This test is available through laboratories in the U.S. and in Canada using PCA3 analyte specific reagents (ASR) from Gen-Probe, and in Europe as the CE-marked PROGENSA® PCA3 in vitro assay. Gen-Probe completed a 500-patient clinical study aimed at securing FDA approval for the commercialization of the PROGENSA® PCA3 test in the U.S. and filed a PMA in September 2010. For more information, visit www.diagnocure.com.
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 hypotheses 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, clinical studies 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 the heading "Risk Factors".
DiagnoCure undertakes no obligation to publicly update or revise any
forward‐looking statements contained herein unless required by the
applicable securities laws and regulations.
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