FDA Approves Gen-Probe's APTIMA® HPV Assay, New Molecular Test to Detect Virus that Causes Cervical Cancer

SAN DIEGO, Oct. 31, 2011 /PRNewswire/ -- Gen-Probe Incorporated (NASDAQ: GPRO) announced today that the US Food and Drug Administration (FDA) has approved its APTIMA HPV assay, an amplified nucleic acid test that detects high-risk strains of human papillomavirus (HPV) that are associated with cervical cancer and precancerous lesions.  The test has been approved to run on Gen-Probe's fully automated, high-throughput TIGRIS instrument system.

"We believe our APTIMA HPV assay will offer physicians and patients a more accurate screening test for cervical cancer, and significantly improve testing efficiency for our laboratory customers," said Carl Hull, Gen-Probe's president and chief executive officer.  "FDA approval represents a major milestone for the Company, since developing the APTIMA HPV assay was the largest and most complex diagnostic R&D program we have ever completed."

The APTIMA HPV assay detects 14 high-risk HPV types associated with cervical cancer and precancerous lesions.  Testing is performed from ThinPrep liquid cytology specimens routinely used for Pap testing.  Unlike other FDA-approved, DNA-based HPV tests, the APTIMA HPV assay detects messenger RNA over-expressed from two viral oncogenes that are integral to the development of cervical cancer.

"Most HPV infections clear up on their own, so it's important to identify those persistent, high-risk infections that are most likely to lead to cervical cancer," said Tom Wright, MD, professor of pathology and cell biology at the Columbia University Medical Center.  "In numerous clinical studies involving approximately 45,000 women, the APTIMA HPV assay has consistently shown similar sensitivity and better specificity than the most frequently used DNA-based test.  This means the APTIMA HPV assay is highly accurate in detecting cervical disease, but is less likely to raise false alarms that can result in unnecessary medical procedures."  

The APTIMA HPV assay is approved to test women age 21 and older whose Pap tests showed atypical squamous cells of undetermined significance (ASC-US), meaning they were neither normal nor clearly indicative of pre-cancerous changes, and to screen women age 30 and older as an adjunct to Pap testing.  This means the assay can be used to meet consensus guidelines for cervical cancer screening recommended by leading US medical organizations.  "Physicians can use the APTIMA HPV test to make early, more accurate decisions about patient care, which in turn may prevent many women from developing a potentially deadly disease," Dr. Wright said.

FDA approval was based on data from the CLEAR (CLinical Evaluation of APTIMA HPV RNA) trial, which analyzed approximately 11,000 women undergoing routine Pap testing at 18 US clinics.  In the study, the APTIMA HPV assay showed similar sensitivity for the detection of cervical disease as an FDA-approved, DNA-based test.  However, the specificity of the APTIMA HPV assay was higher than that of the DNA-based test, and this advantage was statistically significant.

About the TIGRIS System

Gen-Probe's TIGRIS system is the first fully automated, high-throughput molecular testing system, and the only one approved for use with an HPV test.  More than 200 TIGRIS systems are being used today by US clinical laboratories.  The system has been cleared by the FDA to test for:

• Chlamydia and gonorrhea, two common bacterial sexually transmitted diseases (STDs), with the APTIMA Combo 2, APTIMA CT and APTIMA GC assays;
• Trichomonas vaginalis, the cause of a common parasitic STD, with the APTIMA Trichomonas assay;
• Human papillomavirus, with the APTIMA HPV assay.

The TIGRIS system can process up to 1,000 patient samples in a day, generating any combination of Chlamydia/gonorrhea, trichomonas or HPV test results.  The chemistry and format of the three assays are identical, so they can be run back-to-back with only a simple change of reagents.

In addition, a single ThinPrep liquid Pap sample can be tested with all three assays mentioned above, maximizing efficiency for labs, as well as convenience for patients and physicians.

Business Details

"We are encouraged by recent market research that confirms an HPV test with better specificity will be highly valued by key opinion leaders and physicians, and that full automation is extremely important to testing laboratories," said Ingo Chakravarty, who recently joined Gen-Probe as vice president and general manager of women's health.  "We are making good progress on the commercial strategies and investments that will enable us to capitalize on this substantial long-term opportunity."

Gen-Probe expects to launch its APTIMA HPV assay in the United States within the next two weeks.  The Company believes that laboratories will take two to three months to complete their required validations after commercial agreements are established.  Gen-Probe therefore anticipates recording its first US revenues from the assay late in the first quarter of 2012.

About Gen-Probe

Gen-Probe 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 is headquartered in San Diego and employs approximately 1,400 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 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 these include but are not limited to: (i) the chance that additional studies of our APTIMA HPV assay may not be favorable; (ii) the possibility that the market for the sale of our APTIMA HPV assay may not develop as expected; (iii) 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; (iv) the risks created by our dependence on a small number of contract instrument manufacturers and single source suppliers of raw materials; (v) the possibility that changes in third-party reimbursement policies regarding our products could adversely affect sales; (vi) changes in government regulation affecting our products could harm our sales and increase our development costs; and (vii) 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
Vice president, investor relations and
corporate communications
858-410-8673

SOURCE Gen-Probe Incorporated