SAN DIEGO, Sept. 21 /PRNewswire-FirstCall/ -- Gen-Probe
(Nasdaq: GPRO) announced today that the Company has submitted a
Premarket Approval Application (PMA) to the US Food and Drug
Administration (FDA) for its PROGENSA® PCA3 assay, a new molecular
test that may help determine the need for repeat biopsies in men
suspected of having prostate cancer.
"Based on the results of our US clinical study, data from
numerous peer-reviewed publications, and our European commercial
experience, we believe the PROGENSA PCA3 assay can help determine
the need for repeat prostate biopsies, thereby improving patient
care," said Carl Hull, Gen-Probe's
president and chief executive officer. "In addition, this
regulatory submission represents the second of four that we expect
to complete in the United States
this year. Together, these new products will start an
important new sales growth cycle for the Company."
Gen-Probe is seeking FDA approval to use the PROGENSA PCA3 assay
to test urine samples from men who previously have had a negative
prostate biopsy. In support of this objective, the Company
conducted a prospective, multicenter clinical study of the assay
that enrolled 507 men. The trial began in August of 2009 and
concluded in May of 2010. Gen-Probe intends to present the
results of the study at a future medical meeting.
The FDA has formally filed Gen-Probe's PMA, and has advised the
Company that a meeting of the Medical Devices Advisory Committee's
Immunology Panel will be required to support approval of the PMA.
No date for this meeting has been set.
About Prostate Cancer and PCA3
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 218,000 Americans will be
newly diagnosed with prostate cancer in 2010, and that
approximately 32,000 men will die from the disease.
PCA3 is a gene that is highly over-expressed in more than 90% of
prostate cancers, and that can be quantified in urine specimens
following a digital rectal examination. Studies have shown that
because PCA3 is highly specific for prostate cancer, it predicts
the results of repeat biopsies more accurately than traditional
prostate-specific antigen (PSA) testing.
Data from approximately 30 peer-reviewed publications suggest
that PCA3 testing, when used with other patient information, may
help address some of the well-known challenges urologists face when
identifying prostate cancer, such as identifying clinically
relevant cancers that need to be treated while minimizing
unnecessary biopsies.
Gen-Probe's PROGENSA PCA3 assay, which has been CE-marked for
sale in the European Union, is the first urine-based molecular
diagnostic assay for prostate cancer. The test has not been
approved for marketing in the United
States. Gen-Probe acquired exclusive worldwide
diagnostic rights to the PCA3 gene from DiagnoCure in November of
2003.
About Gen-Probe
Gen-Probe Incorporated 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 has approximately 27
years of expertise in nucleic acid testing (NAT), and received the
2004 National Medal of Technology, America's highest honor for
technological innovation, for developing NAT assays for blood
screening. Gen-Probe is headquartered in San Diego and employs approximately 1,300
people. For more information, go to 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 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 risk that an FDA
advisory panel will not recommend our PCA3 test; (ii) the risk that
our PCA3 test will not be approved for marketing in the timeframe
we expect, if at all; (iii) the possibility that the market for the
sale of our PCA3 product may not develop as expected; (iv) the risk
that we may not be able to compete effectively; (v) the risk that
we may not be able to maintain our current corporate collaborations
and enter into new corporate collaborations or customer contracts;
and (vi) 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 Gen-Probe
faces and a discussion of the Company's financial statements and
footnotes, see documents filed with the SEC, including the 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.
Contact:
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Michael Watts
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Vice president, investor
relations and corporate communications
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858-410-8673
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SOURCE Gen-Probe
Copyright . 21 PR Newswire