- Agreement Complements Gen-Probe's Pipeline of Innovative Prostate Cancer

Diagnostics, May Augment Clinical Utility of Molecular Testing -

SAN DIEGO, May 1 /PRNewswire-FirstCall/ -- Gen-Probe Incorporated (Nasdaq: GPRO) has licensed from the University of Michigan the exclusive worldwide rights to develop diagnostic tests for recently discovered genetic translocations that have been shown in preliminary studies to be highly specific for prostate cancer tissue.

A translocation is the physical joining together, or fusion, of two pieces of DNA in an aberrant fashion. In the October 28, 2005 issue of the prestigious, peer-reviewed journal Science, researchers from Michigan, in collaboration with scientists from Brigham and Women's Hospital, a teaching affiliate of Harvard Medical School, published early-stage research that indicated that 23 of 29 cancerous prostate samples contained the newly discovered translocations. Researchers who have since tested approximately 300 samples at four laboratories have confirmed that between 60% and 80% of cancerous prostate tissues contain the translocations, but have not found the translocations in healthy prostate tissue.

"This discovery could prove to be one of the most exciting breakthroughs in prostate cancer diagnostics to date," said Larry Mimms, Ph.D., Gen-Probe's executive vice president for research and development. "We are delighted to work with Dr. Chinnaiyan and his colleagues to develop molecular assays that complement our existing portfolio of prostate cancer markers. By combining our proprietary technology platform with innovative markers from DiagnoCure, Corixa, the Center for Prostate Disease Research and now the University of Michigan, we believe we have amassed one of the most exciting pipelines in prostate cancer diagnostics."

"Gene fusions or translocations have the potential to be exquisitely specific markers for prostate cancer," said Arul Chinnaiyan, M.D., Ph.D., who directed the Science study mentioned above and is the S.P. Hicks Endowed Professor of Pathology in the University of Michigan Medical School. "In addition to being useful as a specific prostate cancer marker, these gene fusions likely play a role in prostate cancer development and analogous gene fusions may be present in other common solid tumors."

Under the terms of the agreement, Gen-Probe will pay Michigan an up-front license fee of $0.5 million, which will be recorded as research and development expense in the second quarter. Gen-Probe also will pay royalties on any eventual product sales, as well as development milestones. In addition, Gen-Probe will fund research at Michigan over the next five years to discover other potential prostate cancer translocations.

The specific translocations discovered by Dr. Chinnaiyan are fusions between the prostate-specific, androgen-responsive gene TMPRSS2 and members of the ETS family of genes, including ERG and ETV1, which were previously known to be involved in other types of cancer such as a bone cancer called Ewing's sarcoma. TMPRSS2 is turned on in the presence of androgen, a key regulatory hormone in the prostate. According to Dr. Chinnaiyan's discovery, when TMPRSS2 is abnormally fused with ETS genes, androgen may activate uncontrolled cell growth and proliferation, possibly leading to the development of prostate cancer.

Common genetic translocation events have been studied extensively in blood cell cancers such as leukemia and lymphoma, resulting in new molecular diagnostic tests and drug therapies for these diseases. However, Dr. Chinnaiyan's discovery represents the first such demonstration of recurrent chromosomal rearrangements in a common solid tumor such as prostate cancer, where cancer transformation originates in epithelial cells lining the prostate glands.

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 20 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 900 people. For more information, go to www.gen-probe.com .

Caution Regarding Forward-Looking Statements

Any statements in this press release about our 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 new prostate cancer products, including those based on PCA3 and/or the translocations described here, will not be cleared for marketing in the timeframes we expect, if at all, (ii) the risk that development of these products will not be successful, (iii) the possibility that the market for the sale of these products may not develop as expected, (iv) we may not be able to compete effectively, (v) we may not be able to maintain our current corporate collaborations and enter into new corporate collaborations or customer contracts, and (vi) we are dependent on third parties for the distribution of some of our products. 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
Sr. director, investor relations and
corporate communications
858-410-8673

SOURCE
Gen-Probe Incorporated
05/01/2006