Prodesse's ProFlu-ST(TM) Assay Receives European CE Mark

SAN DIEGO, November 12 - — Molecular Test Differentiates 2009 H1N1 Influenza Virus from Two
Common Seasonal Strains –

Gen-Probe Incorporated (Nasdaq: GPRO) today announced that Prodesse's
ProFlu-ST(TM) assay, a molecular test that detects the 2009 H1N1 influenza
virus and differentiates it from two common seasonal strains, has received
its CE (Conformite Europeenne) Mark, enabling it to be commercialized in the
European Union.

Prodesse is a wholly-owned subsidiary of Gen-Probe, a global leader in
molecular diagnostics.

"Many experts expect continued high levels of 2009 H1N1 infections this
flu season, along with a return of either or both of the seasonal flu
strains, so we believe the ability of the ProFlu-ST assay to differentiate
among the strains can help physicians provide personalized care," said Steve
Kondor, Gen-Probe's senior vice president of sales and marketing. "This test
complements Prodesse's ProFlu+(TM) assay and broadens the portfolio of
products sold by our growing European sales force."

The ProFlu-ST assay uses real-time RT-PCR (polymerase chain reaction) to
detect and identify the 2009 H1N1 influenza virus, the seasonal influenza
A/H1 virus, and the seasonal influenza A/H3 virus. Because these three
influenza A subtypes currently have different susceptibilities to antiviral
drugs, identifying the specific strain can help clinicians treat patients
appropriately.

Gen-Probe expects that the ProFlu-ST assay will often be used in
conjunction with Prodesse's ProFlu+ assay, which was CE-marked in 2007. The
ProFlu+ test detects and discriminates influenza A virus, influenza B virus
and Respiratory syncytial virus (RSV). A single patient sample is sufficient
for testing with both the ProFlu-ST and ProFlu+ assays.

The real-time RT-PCR technology used in both assays is simple to use and
easily integrates into a lab's existing workflow. Both products have been
optimized for use with automated extraction technology that minimizes
technician hands-on time. This ease-of-use enables labs to quickly validate
the products. Test results can be obtained in as little as three hours using
the assays - a significant improvement over culture-based methods that can
take up to weeks to produce a result. During a public health emergency, this
speed to result and the exceptional sensitivity of molecular testing are
extremely important from an infection control perspective.

As previously announced, the US Food and Drug Administration (FDA) has
granted an EUA (emergency use authorization) for the Prodesse ProFlu-ST assay
to be used in CLIA high complexity laboratories for the diagnosis of 2009
H1N1 influenza virus infection, aided by an algorithm that relies on seasonal
influenza A/H1 virus and seasonal influenza A/H3 virus results, from a single
sample in individuals who are diagnosed with influenza A by currently
available FDA-cleared or authorized devices.

The US Secretary of Health and Human Services has declared a public
health emergency because of the outbreak of the pandemic flu virus. The FDA
has issued EUAs to make important diagnostic and therapeutic tools available
to public health and medical personnel in order to identify and respond to
the 2009 H1N1 influenza virus under certain circumstances.

The FDA has not cleared or approved any tests for the identification of
the 2009 H1N1 influenza virus. The EUA authority allows the FDA, based on the
evaluation of available data, to authorize the use of unapproved or uncleared
medical products following a determination and declaration of emergency,
provided certain criteria are met. In the case of the ProFlu-ST assay, the
FDA has only authorized its use for the duration of the emergency, which is
currently set to expire on April 26, 2010, unless it is terminated, revoked
sooner or renewed.

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 more than 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.

In October, Gen-Probe completed its acquisition of Prodesse, Inc.
Prodesse develops molecular diagnostic reagents for a variety of infectious
disease applications. Prodesse sells three FDA 510(k) cleared products in the
United States, and three additional CE-marked products in Europe.

Caution Regarding Forward-Looking Statements

Any statements in this news release relating to 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 expected benefits of the ProFlu-ST assay,
its commercial uptake, and the duration of the current influenza public
health emergency 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 these risks, uncertainties and assumptions
include, but are not limited to, the risk that Gen-Probe will not
commercialize the ProFlu-ST assay effectively in Europe, that the test may
not ultimately obtain FDA clearance or approval, or that the approval would
not occur prior to the expiration of the FDA's emergency use authorization.
The foregoing list sets forth some, but not all, of the factors that could
affect Gen-Probe's ability to achieve results described in any
forward-looking statements. For additional information about risks and
uncertainties Gen-Probe faces and a discussion of its 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. Gen-Probe
assumes no obligation and expressly disclaims any duty to update
forward-looking statements to reflect events or circumstances after the date
of this news release or to reflect the occurrence of subsequent events.

    Contact:
    Michael Watts
    Vice president, investor relations and
    corporate communications
    +1-858-410-8673

Michael Watts, Vice president, investor relations and corporate communications of Gen-Probe Incorporated, +1-858-410-8673