FDA approves PROGENSA® PCA3 assay

Feb 15, 2012, 07:36 ET from DIAGNOCURE

First Urine-Based Molecular Test to Help Determine Need for Repeat Prostate Biopsies

Test May Help Reduce Unnecessary Repeat Prostate Biopsies

QUEBEC CITY, Feb. 15, 2012 /PRNewswire/ - DiagnoCure, Inc. (TSX: CUR), a Quebec life sciences company that develops and commercializes high‐value cancer diagnostic tests, announced today that the US Food and Drug Administration (FDA) has approved Gen-Probe's (NASDAQ: GPRO) PROGENSA® PCA3 (Prostate Cancer Antigen 3) assay, the first molecular test to help determine the need for repeat prostate biopsies in men who have had a previous negative biopsy.

"We are delighted about this long awaited FDA approval for the PCA3 test, which we believe will greatly improve how physicians decide what interventions to do with men who have had a negative biopsy," stated Dr. Yves Fradet, President and Chief Medical Officer of DiagnoCure. "This is a pivotal achievement for DiagnoCure. We expect it will increase our royalty revenues and will help us keep investing in the development of new and clinically relevant diagnostic tests for cancer".

The PROGENSA PCA3 assay is indicated for use in conjunction with other patient information to aid in the decision for repeat biopsy in men 50 years of age or older who have had one or more previous negative prostate biopsies and for whom a repeat biopsy would be recommended by a urologist based on the current standard of care, before consideration of PROGENSA PCA3 assay results.  A negative PROGENSA PCA3 assay result is associated with a decreased likelihood of a positive biopsy.  A prostate biopsy is required to diagnose cancer.

Important Safety Information

The PROGENSA PCA3 assay should not be used for men with atypical small acinar proliferation (ASAP) on their most recent biopsy.  Men with ASAP on their most recent biopsy should be treated in accordance with current medical guidelines.

The clinical study of the PROGENSA PCA3 assay only included men who were recommended for repeat biopsy.  Therefore, the performance of the assay has not been established in men for whom a repeat biopsy was not already recommended.

FDA approval of the PROGENSA PCA3 assay was based on a clinical study that began in August 2009 and concluded in May 2010.  The study enrolled 495 eligible men at 14 clinical sites.  Gen-Probe submitted a Premarket Approval Application (PMA) to the FDA in August 2010.

In the clinical study, the PROGENSA PCA3 had a negative predictive value of 90%, meaning that a negative PROGENSA PCA3 assay result predicted a negative prostate biopsy 90% of the time.

About Prostate Cancer and the PROGENSA PCA3 Assay

According to the American Cancer Society (ACS), prostate cancer is the second most common type of cancer found in American men (behind skin cancer), and the second-leading cause of cancer death in men (after lung cancer). One in six American men will get prostate cancer during his lifetime, and one in 36 will die from it.  The ACS estimates that about 241,000 Americans were newly diagnosed with prostate cancer in 2011, and that approximately 34,000 men died from the disease.

PCA3 is a gene that is highly over-expressed in prostate cancers.  Following a digital rectal examination, the PCA3 gene can be quantified in urine specimens together with the prostate-specific antigen (PSA) gene to generate a PCA3 score.  Studies have shown that because the PCA3 gene is highly specific for prostate cancer, it predicts the results of repeat biopsies more accurately than traditional serum PSA testing in patients who have had one or more previous negative prostate biopsies.

Data from more than 80 peer-reviewed publications suggest that PCA3 gene testing, when used with other patient information, may help address some of the well-known challenges urologists face, such as identifying prostate cancers while reducing unnecessary repeat biopsies.

Gen-Probe's PROGENSA PCA3 assay is the first urine-based molecular diagnostic assay to aid in the decision for repeat biopsy. The test has received regulatory approval and is available for sale in the United States, Canada and the European Union.

DiagnoCure granted Gen-Probe exclusive worldwide diagnostic rights to the PCA3 gene in November 2003.

About DiagnoCure

DiagnoCure (TSX: CUR) is a life sciences company that develops and commercializes high-value cancer diagnostic tests that increase clinician and patient confidence in making critical treatment decisions. In 2008, the Company launched the PrevistageTM GCC Colorectal Cancer Staging Test through its U.S. CLIA laboratory, and granted the worldwide exclusive rights to this test to Signal Genetics in June 2011. The Company also 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 biomarker. The PROGENSA® PCA3 test is commercialized in Europe under CE mark and is now approved for commercialization in Canada and the United States. For more information, visit 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 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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