SAN DIEGO, February 15, 2012 /PRNewswire/ --
-- Test May Help Reduce Unnecessary
Repeat Prostate Biopsies --
Gen-Probe (NASDAQ: GPRO) announced today the US Food and Drug
Administration (FDA) has approved its PROGENSA® PCA3
(Prostate Cancer gene 3) assay, the first molecular test to help
determine the need for repeat prostate biopsies in men who have had
a previous negative biopsy.
To view the multimedia assets associated with this release,
please click:
http://www.multivu.com/mnr/53530-gen-probe-progensa-pca3-prostate-cancer-psa
(Photo:
http://photos.prnewswire.com/prnh/20120215/MM40563)
"When used in conjunction with other diagnostic information, our
PROGENSA PCA3 assay provides clinically important information that
helps physicians and their patients make better, more informed
decisions about one of the most vexing problems in prostate cancer
diagnosis," said Carl Hull,
Gen-Probe's Chairman and Chief Executive Officer. "From a
commercial perspective, this is the third of four potential US
regulatory approvals that we expect to generate a significant new
sales growth cycle for the Company."
"Over-expression of the PCA3 gene is highly specific to
cancerous prostate tissue," said John
Wei, MD, MS, Professor of Urology at the University of Michigan Health System. "When
evaluated with other risk factors, the PROGENSA PCA3 assay fills an
important unmet clinical need by helping physicians identify which
men suspected of having prostate cancer should undergo a repeat
prostate biopsy."
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.
Gen-Probe acquired exclusive worldwide diagnostic rights to the
PCA3 gene from DiagnoCure (CUR: TO) in November 2003.
About Gen-Probe
Gen-Probe is a global leader in the development, manufacture and
marketing of rapid, accurate and cost-effective molecular
diagnostic products and services that are used primarily to
diagnose human diseases, screen donated human blood, and ensure
transplant compatibility. Gen-Probe is headquartered in
San Diego and employs
approximately 1,400 people. For more information, go to
http://www.gen-probe.com.
Caution Regarding Forward-Looking Statements
Any statements in this press release about Gen-Probe's
expectations, beliefs, plans, objectives, assumptions or future
events or performance are not historical facts and are
forward-looking statements. These statements are often, but
not always, made through the use of words or phrases such as
believe, will, expect, anticipate, estimate, intend, plan and
would. For example, statements concerning the development and
commercialization of new products, regulatory approvals, customer
adoption, and results of future clinical studies are all
forward-looking statements. Forward-looking statements are
not guarantees of performance. They involve known and unknown
risks, uncertainties and assumptions that may cause actual results,
levels of activity, performance or achievements to differ
materially from those expressed or implied. Some of the
risks, uncertainties and assumptions that could cause actual
results to differ materially from estimates or projections
contained in the forward-looking statements include but are not
limited to: (i) the possibility that the market for the sale of our
PROGENSA PCA3 product in the United
States or Canada may not
develop as expected; (ii) the risk that we may not be able to
compete effectively; (iii) the risk that adequate reimbursement
will not be available for our PROGENSA PCA3 assay; (iv) the risk
that we may not be able to maintain our current corporate
collaborations and enter into new corporate collaborations or
customer contracts; and (v) the risk that third parties may not
distribute our products effectively. The foregoing describes
some, but not all, of the factors that could affect our ability to
achieve results described in any forward-looking statements.
For additional information about risks and uncertainties we face
and a discussion of our financial statements and footnotes, see
documents we file with the SEC, including our most recent annual
report on Form 10-K and all subsequent periodic reports. We
assume no obligation and expressly disclaim any duty to update any
forward-looking statement to reflect events or circumstances after
the date of this news release or to reflect the occurrence of
subsequent events.