-Progensa PCA3 Test Approved by the FDA-
-Total Revenues Up 90% Year-over-Year-
Report is Available for Download at: www.lifesciadvisors.com/clients/diagnocure
Last Friday morning, DiagnoCure, Inc. (TSX: CUR) issued a press release and held a conference call discussing the Company’s first quarter 2012 financial results and progress made during the first quarter. During the first quarter of 2012, the FDA announced the approval of Gen-Probe’s Progensa PCA3 prostate cancer diagnostic test, which was licensed to Gen-Probe from DiagnoCure.
Progensa PCA3 Diagnostic Assay – The First Molecular Prostate Cancer Test Approved by the FDA. The biggest piece of news this quarter for DiagnoCure and investors was the February 15 approval of Gen-Probe’s Progensa PCA3 assay, which DiagnoCure out-licensed to them previously. The Progensa PCA3 assay is the first molecular diagnostic test for prostate cancer to determine the need for repeat biopsies in men who have had at least one previous negative biopsy. We believe Progensa PCA3’s impact on the prostate cancer treatment paradigm can be significant as it helps lower the amount of unnecessary prostate biopsies that can lead to morbidity and are quite costly (~$2000 per biopsy). We believe the FDA approval of Progensa PCA3 should positively impact sales in the US and should have a modest impact overseas.
New Data Suggests that GCC Effectively Predicts Prostate Cancer Disease Mortality and Survival. With regards to DiagnoCure’s other product which is marketed by Signal Genetics, new data for the Previstage GCC Colorectal Cancer Staging Test were presented at the 2012 ASCO Gastrointestinal Cancer Symposium in San Francisco, CA, during January. At the symposium, Signal Genetics presented a pooled meta-analysis of 310 patients that showed that GCC levels allow an effective stratification of patients between low and high risk of reoccurrence disease groups. The 5-year survival for low and high risk patients were 11% and 32%, respectively. Moreover, higher detections levels of GCC in lymph nodes were significantly associated with an increased risk of mortality, disease-specific survival and disease-free survival. This means that GCC levels effectively predict the probability of mortality and survival in patients with prostate cancer. We believe this data helps re-confirm the prognostic capabilities of the Previstage GCC test in patients with colon cancer.