SAN DIEGO, Nov. 29, 2010 /PRNewswire-FirstCall/ -- Gen-Probe
Incorporated (Nasdaq: GPRO) announced today that the Company has
submitted a Premarket Approval Application (PMA) to the US Food and
Drug Administration (FDA) for its APTIMA® HPV (human
papillomavirus) assay, a new molecular test that detects high-risk
HPV infections that are associated with cervical cancer and
precancerous lesions.
"Developing and testing our APTIMA HPV assay was our largest and
most complex R&D program for a new diagnostic test, so we are
very pleased to have filed for regulatory approval ahead of our
year-end goal," said Carl Hull,
Gen-Probe's president and chief executive officer. "We
believe our assay, if approved by the FDA, could contribute
significantly to women's health by reducing the number of 'false
positive' HPV test results that lead to unnecessary and expensive
medical procedures. From a business perspective, this
regulatory submission represents the last of five we have completed
in the United States this year.
When approved, we expect these new products to start an
important new sales growth cycle for the Company."
Gen-Probe's pivotal study, known as the CLEAR (CLinical
Evaluation of APTIMA HPV RNA) trial, involved more than 13,000
women undergoing routine Pap testing at 19 U.S. clinics. The
trial included two arms to validate clinical utility, consistent
with consensus HPV testing guidelines recommended by leading U.S.
medical organizations. One arm enrolled women whose Pap
results were classified as atypical squamous cells of undetermined
significance (ASC-US), meaning they were neither normal nor clearly
indicative of changes associated with progression to cervical
cancer. In these cases, HPV testing can help determine
appropriate patient management. The other arm enrolled women
over age 30 whose Pap results were normal. This arm assessed
the ability of the APTIMA HPV test to identify women who were at
greater risk for cervical cancer.
Gen-Probe is seeking regulatory approval to run the APTIMA HPV
assay on the Company's fully automated, high-throughput TIGRIS®
instrument system. Approximately 200 TIGRIS systems are being
used today by U.S. clinical laboratories to test for Chlamydia and
gonorrhea, two common bacterial sexually transmitted diseases.
About the APTIMA HPV Assay
The APTIMA HPV assay is an amplified nucleic acid test that
detects 14 high-risk HPV types that are associated with cervical
cancer. More specifically, the assay detects messenger RNA
(mRNA) from two viral oncogenes, E6 and E7, which are more
prevalent in the severe cervical lesions likely to progress to
cervical cancer. Gen-Probe believes targeting E6/E7 mRNAs may
more accurately identify women at higher risk of having, or
developing, cervical cancer than competing assays that target HPV
DNA.
Previous studies of the APTIMA HPV assay from outside
the United States have been
published in peer-reviewed journals including the International
Journal of Cancer and the International Journal of Gynecological
Cancer. These studies have shown that the APTIMA HPV assay is
highly sensitive for the detection of cervical cancer and
precancerous lesions, while generating fewer "false positive"
results for cervical disease than DNA-based HPV tests.
The CLEAR trial is the first large study of the APTIMA HPV assay
in a US patient population. Gen-Probe intends to present the
results of the trial at a future medical meeting.
About HPV and Cervical Cancer
HPV is a group of viruses with more than 100 types, 14 of which
are high risk for the development of cervical cancer. Most
women will be infected with HPV at some point, but the majority of
these infections are transient and resolve without clinical
symptoms or consequences. However, a small number of HPV
infections persist and result in disease ranging from minor
dysplasia to cervical cancer. Since most HPV infections do
not result in cancer, more specific tests are needed to identify
women at greater risk of developing that disease.
The most common test used for cervical cancer screening in
the United States is the Pap test.
Pap screening has dramatically reduced the number of deaths
from cervical cancer. Even so, the American Cancer Society
estimates that there will be more than 12,000 new cases of invasive
cervical cancer in 2010, and more than 4,000 deaths from the
disease.
Despite the success of Pap testing in reducing cervical cancer
mortality, it does have limitations. One such limitation is
poor sensitivity for detecting cervical disease from individual Pap
smears, which means the test misses cancers or precancerous
changes. As a result, regular and repeated Pap testing is
required to effectively detect a high proportion of cervical
cancers. Another limitation is that approximately 2 million
of the 50 million Pap tests performed annually in the United States have equivocal results,
which are known as ASC-US. These women are often subjected to
additional invasive tests, including biopsies, most of which prove
negative for cervical disease.
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, potential regulatory
approvals, and customer adoption 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 by any forward-looking statement. 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 the APTIMA HPV assay will not be
approved for marketing in the timeframe we expect, or may never be
approved; (ii) the chance that additional studies of our APTIMA HPV
assay may not be favorable; (iii) the possibility that the market
for the sale of our APTIMA HPV assay may not develop as expected;
(iv) the risk that we may not be able to compete effectively with
other companies already selling HPV diagnostic products or which
launch such products in the future; (v) the risks created by our
dependence on a small number of contract instrument manufacturers
and single source suppliers of raw materials; (vi) possible changes
in third-party reimbursement policies regarding our products could
adversely affect sales of these products; (vii) changes in
government regulation affecting our products could harm our sales
and increase our development costs; and (viii) litigation involving
the assertion of third party patent rights could be expensive and
divert management's attention, and/or result in damages or
injunctive relief. 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.
Contact:
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Michael Watts
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Vice president, investor
relations and
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corporate
communications
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858-410-8673
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SOURCE Gen-Probe Incorporated