FDA approves PROGENSA(R) PCA3 assay
First Urine-Based Molecular Test to Help Determine Need for Repeat
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((R)) 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
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
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
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.
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 Previstage(TM )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(R) 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.