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DiagnoCure announces first quarter 2009 results

Ticker Symbol: CUR

PCA3 royalty revenue triples and GCC sales start

QUEBEC CITY, March 17 /PRNewswire-FirstCall/ - DiagnoCure Inc. (TSX: CUR), a life sciences company commercializing high-value cancer diagnostic tests and delivering lab services, announced a net loss of $3,440,655 or $0.08 per share for the first quarter ending January 31, 2009. These results are substantially in line with Management expectations. They reflect budgeted sales and marketing initiatives to promote the Previstage(TM) GCC Colorectal Cancer Staging Test and further product optimization activities. At the end of the quarter, cash, short-term investments and long-term investments stood at $16,593,947.

In particular, the results of the first quarter reflect non-recurrent expenses in the order of $433,000, including the severance pay for the November lay-off, and a special educational grant opportunity for DiagnoCure at the January 2009 Gastrointestinal Cancers Symposium ("ASCO GI") satellite symposium on molecular markers.

Highlights of the Quarter

Previstage(TM) GCC

During the last edition of the 2009 ASCO GI in January, DiagnoCure was selected to sponsor an independent panel of three key colorectal cancer opinion leaders, Dr. Edith P. Mitchell (Thomas Jefferson University), Dr. Stanley Hamilton (University of Texas M.D. Anderson Cancer Center) and Dr. Daniel Sargent (Mayo Clinic), who reviewed different markers for the prognosis of colorectal cancer patients. It was suggested that patients with GCC positive lymph nodes could be considered and treated as stage III patients.

On February 18, 2009, the Journal of the American Medical Association published positive results on the prognostic value of the GCC marker, to which DiagnoCure secured exclusive worldwide diagnostic rights in 2007, and which is the marker used in the Company's Previstage(TM) GCC Colorectal Cancer Staging Test. This major prospective 5-year multicenter study of 425 enrolled patients demonstrated that guanylyl cyclase C ("GCC" or "GUCY2C") is the strongest independent predictor of colorectal cancer recurrence in patients considered low risk by current assessment methods. In a group of 257 stage I and II colorectal cancer patients, when GCC was considered independently from other factors, patients whose nodes were GCC positive were 4.7 times more likely to develop disease recurrence than those whose nodes were GCC negative. In fact, patients with GCC positive nodes had a risk of recurrence comparable to that of stage III colorectal cancer patients.

PCA3 testing

Gen-Probe, DiagnoCure's PCA3 development and commercialization partner, confirmed during its fourth quarter and annual results conference call that the European sales of the Progensa(TM) PCA3 test continued to increase, driven by articles published in peer-reviewed literature and strong marketing efforts. In addition, the potential acquisition of Tepnel would allow Gen-Probe to enhance its ongoing sales efforts of the PCA3 test in Europe by leveraging Tepnel's European market knowledge, established infrastructures and manufacturing facilities.

Results for the first quarter ended January 31, 2009

Total revenues for the first quarter of 2009 were $400,123 compared with $491,455 for the first quarter of 2008. Royalty from Gen-Probe tripled, from $40,787 to $132,311 for the first quarter of 2009. This increase is attributable to the sales of Progensa(TM) PCA3 in Europe by Gen-Probe.

Interest income decreased by $163,606, to $171,824 for the first quarter of 2009 compared with $335,430 for the first quarter of 2008. The decrease is attributable to DiagnoCure's use of fund to finance the operating activities and the reduction of interest levels in its investments.

Cost of sales decreased by $56,958, from $69,790 for the first quarter of 2008 to $12,832 for 2009. This decrease translates into a higher margin due to the end of manufacturing activities related to ImmunoCyt(TM)/uCyt+(TM).

Based on the above, for the first quarter of 2009, DiagnoCure recorded a net loss of $3,440,655 or $0.08 per share, compared with $2,685,309 or $0.06 per share, for the same period of 2008. These results are substantially in line with Management expectations and reflect activities undertaken during this quarter, in line with the Company's plans and on-going commitment to develop high-value diagnostic tests for the detection and management of cancer. At the end of the quarter, cash, short-term and long-term investments stood at $16,593,947, down from $20,130,705 as of October 31, 2008. This decrease of $3,536,758 is due to the use of liquidity to finance the operating activities of this quarter. Management is satisfied that it has adequate cash resources to finance the Company's activities, and will monitor its cash levels.

    Financial Data

                                                      For the first quarter
                                                         ended January 31
                                                        2009         2008
    Sales                                                72,522      115,238
    Revenue under research and license agreement        155,777       40,787
    Interest                                            171,824      335,430
    Total revenues                                      400,123      491,455
    Cost of sales                                        12,832       69,790
    Gross margin                                        387,291      421,665
    Operating expenses (before stock-based
     compensation)                                    3,668,667    2,817,680
    Net loss before stock-based compensation         (3,281,376)  (2,396,015)
    Stock-based compensation                            190,042      289,294
    Net loss before income taxes                     (3,471,418)  (2,685,309)
    Future income taxes                                  30,763            -
    Net loss                                         (3,440,655)  (2,685,309)
    Basic and diluted net loss per share                  (0.08)       (0.06)
    Weighted average number of common shares
     outstanding                                     42,796,160   41,720,130

    Consolidated Balance Sheets

                                                         As at January 31
                                                        2009         2008
    Cash, cash equivalents, temporary and long-term
     investments                                     16,593,947   30,336,246
    Total assets                                     29,353,762   41,955,296
    Shareholders' equity                             26,392,935   37,797,840

About DiagnoCure

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 Previstage(TM) GCC Colorectal Cancer Staging Test, the first GCC-based molecular test for the management of colorectal cancer. A major study published in the February 18, 2009, edition of the JAMA ("Journal of the American Medical Association") demonstrated that GCC, to which DiagnoCure secured exclusive worldwide diagnostic rights, is the strongest independent predictor of colorectal cancer recurrence. 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 marker. This test is also available through laboratories in the U.S. using PCA3 analyte specific reagents (ASR) from Gen-Probe, in Europe as the CE-marked PROGENSA(TM) PCA3 in vitro assay, and in Canada. In addition to its own research, the Company intends to acquire or in-license additional promising cancer biomarkers from both academic and commercial institutions. For more information, visit

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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