Promising Clinical Data on Gen-Probe's APTIMA(R) HPV Test Presented at Major European Medical Meeting

San Diego, November 21 (ots/PRNewswire) -

- New, CE-Marked Molecular Assay May Help Identify Women with
Cervical Cancer or Pre-Cancer More Accurately than Competing
Technologies, Studies Show -

Gen-Probe's (Nasdaq: GPRO) CE-marked APTIMA(R) HPV assay may be
an important new molecular tool to more accurately detect high-risk
human papillomavirus (HPV) infections that are associated with
cervical cancer or precancerous lesions, according to nine oral
presentations and two scientific posters presented last week by
independent and Gen-Probe researchers at the international conference
of the European Research Organization on Genital Infection and
Neoplasia (EUROGIN) in Nice, France.

Gen-Probe's APTIMA HPV assay has been CE-marked for sale in the
European Union, and clinical trials of the test are underway in the
United States. The assay has not been approved for marketing by the
U.S. Food and Drug Administration.

"As a whole, these studies suggest that our new APTIMA HPV assay
may detect high-risk HPV infections that have progressed, or are
progressing, to cervical cancer more specifically than competing
assays that simply detect whether HPV infection is present," said Dan
Kacian, Ph.D., M.D., Gen-Probe's executive vice president and chief
scientist. "Since most HPV infections resolve without causing cancer,
more specific tests are needed to avoid unnecessary and invasive
medical procedures and patient anxiety. Additional longer-term
studies are needed and are underway, but these results give us
continued confidence that our test may play an important role in
helping protect women from both cervical cancer and the adverse
effects of non-specific diagnosis."

In one key presentation at EUROGIN, Joseph Monsonego, M.D.,
EUROGIN scientific director, presented interim results of the French
APTIMA HPV Screening Evaluation (FASE) study from 1,528 women. The
study eventually will include 5,000 women between the ages of 20 and
65. In the study, liquid cytology samples were tested with the
Gen-Probe APTIMA HPV assay and with Digene/Qiagen's Hybrid Capture(R)
2 assay, and the results were compared to the gold standard of
histology (microscopic analysis of cervical tissue).

Dr. Monsonego concluded that in the study to date, the APTIMA HPV
assay had statistically identical sensitivity, but higher
specificity, than the Hybrid Capture 2 test. Other studies of the
APTIMA HPV assay presented at EUROGIN showed similar results in
geographically and clinically diverse patient groups. Additional
details on these studies can be found in the "Science" section of the
Gen-Probe website at http://www.gen-probe.com/global/science.

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 two messenger RNAs
(mRNAs), E6 and E7, that are made in higher amounts when HPV
infections progress toward cervical cancer. Gen-Probe believes
targeting these mRNAs may more accurately identify women at higher
risk of having, or developing, cervical cancer than competing assays
that target HPV DNA. Detecting HPV DNA identifies women who are
infected, but HPV infections are common and most resolve without
causing cervical cancer.

About HPV and Cervical Cancer

HPV is a group of viruses with more than 100 types, 14 of which
have been categorized as high risk for the development of cervical
cancer. While most women will be infected with HPV at some point in
their lives, the majority of these infections are transient and
resolve without any clinical symptoms or consequences. However, a
small number of HPV infections progress and result in disease ranging
from genital warts to cervical cancer. Since most HPV infections do
not result in cancer, there is a need for a more specific test 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. Since the mid-1950s, screening with
the Pap test has dramatically reduced the number of deaths from
cervical cancer. Even so, the American Cancer Society estimates that
there were more than 11,000 new cases of invasive cervical cancer in
2007, as well as nearly 4,000 deaths from the disease.

Despite the success of Pap testing in reducing mortality from
cervical cancer in the United States, it does have limitations. One
such limitation is poor sensitivity of 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.

About Gen-Probe

Gen-Probe Incorporated is a global leader in the development,
manufacture and marketing of rapid, accurate and cost-effective
nucleic acid tests (NATs) that are used primarily to diagnose human
diseases and screen donated human blood. Gen-Probe has approximately
25 years of NAT expertise, 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 1,000 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 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 our APTIMA HPV
assay will perform poorly in its US clinical trial, (ii) the risk
that the APTIMA HPV assay will not be cleared for marketing in the
timeframe we expect, if at all, (iii) the chance that additional
studies of our APTIMA HPV assay may not confirm the results discussed
here, (iv) the possibility that the market for the sale of our APTIMA
HPV assay may not develop as expected, (v) we may not be able to
compete effectively with other companies already selling HPV
diagnostic products or which launch such products in the future, (vi)
we depend on a small number of contract manufacturers and single
source suppliers of raw materials, (vii) changes in third-party
reimbursement policies regarding our products could adversely affect
their sales, (viii) changes in government regulation affecting our
products could harm our sales and increase our development costs, and
(ix) 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:
Michael Watts
Senior director, investor relations and
corporate communications
+1-858-410-8673

ots Originaltext: Gen-Probe
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Michael Watts, Senior director, investor relations and corporate
communications of Gen-Probe, +1-858-410-8673