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Gen-Probe has a robust development pipeline of innovative nucleic acid tests (NATs). For example, the Company is developing NATs to detect prostate cancer, drug-resistant healthcare-associated infections, and the human papillomavirus, which causes cervical cancer. In addition, Gen-Probe is working with
General Electric and Millipore to develop NATs that detect microorganisms that commonly contaminate industrial processes.
For scientific publications on many of the development projects described below, go to: http://www.gen-probe.com/science/publications_posters.aspx.
PROGENSA™ PCA3 Assay
In Europe, Gen-Probe's PROGENSA PCA3 assay received marketing clearance in 2006. The assay detects the overexpression of a gene called PCA3 in
urine. Studies have shown that PCA3 is highly over-expressed in the vast majority of prostate cancers, indicating that PCA3 may be a useful biomarker for the disease.
Preliminary data show that the PCA3 assay is more specific to prostate cancer than the traditional serum prostate specific antigen (PSA) test, thus decreasing the likelihood of false positive results. PSA is produced by both cancerous and non-cancerous prostate cells. Non-cancerous conditions can therefore
cause elevated serum PSA levels that must be investigated, resulting in unnecessary medical procedures and patient anxiety.
The PROGENSA PCA3 assay remains under development in the United States, and has not been approved for marketing by the FDA.
For more information, go to: http://www.pca3.org/.
APTIMA® HPV Assay
Gen-Probe is developing a NAT to detect high-risk strains of the human papillomavirus, which causes cervical cancer. Gen-Probe's investigational assay employs the familiar suite of APTIMA technologies to target mRNA expression of genes that are known to
contribute to cancer progression. Early data on the assay are promising. Gen-Probe expects to initiate a clinical trial in the United States in early 2008, and plans to introduce a product in Europe in the second half of 2008.
For future updates regarding the development of the APTIMA HPV Assay, register your interest by clicking on the following link. HPVinquiry@gen-probe.com
For more information, go to: http://www.gen-probe.com/news/PressReleaseText.asp?compid=135117&releaseID=675315.
Healthcare-Associated Infections
In 2007, 3M and Gen-Probe announced that the companies have formed an exclusive worldwide collaboration to develop and commercialize rapid, easy-to-use nucleic acid tests to detect certain dangerous healthcare-associated infections (HCAIs) such as
methicillin-resistant Staphylococcus aureus (MRSA).
In the United States, the Centers for Disease Control (CDC) estimate that approximately 90,000 deaths annually are attributable to HCAIs. The CDC issued new guidelines in 2006, outlining strategies to prevent the spread of drug-resistant infections in healthcare settings. The CDC recommended that healthcare
facilities that do not improve their healthcare-associated infection rates implement screening of patients at high risk for carrying drug-resistant bacteria.
HCAIs also are a persistent challenge for hospitals worldwide. A prevalence survey conducted under the auspices of the World Health Organization (WHO) in 55 hospitals in 14 countries, representing four WHO Regions (Europe, Eastern Mediterranean, South-East Asia and Western Pacific), showed an average of 8.7
percent of hospital patients had HCAIs. At any time, over 1.4 million people worldwide suffer from infectious complications acquired in hospitals.
For more information, go to: http://www.gen-probe.com/news/PressReleaseText.asp?compid=135117&releaseID=993051.
Panther Platform
Gen-Probe's TIGRIS® instrument, introduced in 2004, is the only fully automated, high-throughput testing instrument for molecular diagnostics. Now Gen-Probe is developing another innovative instrument, tentatively called the Panther system, to extend the
advantages of the TIGRIS platform to low- and mid-volume laboratories. The Panther system is intended to run key current Gen-Probe assays, as well as future tests, in a fully automated fashion.
Industrial Water
In 2005, GE Infrastructure, Water & Process Technologies, a unit of General Electric Company, and Gen-Probe began collaborating on an exclusive basis to develop, manufacture and commercialize NAT technologies that are designed to detect the unique genetic sequences of
microorganisms in selected industrial water applications.
For more information, go to: http://www.gen-probe.com/news/PressReleaseText.asp?compid=135117&releaseID=731605.
Biopharmaceutical Manufacturing
In 2005, Millipore and Gen-Probe formed an alliance to develop, manufacture and commercialize on an exclusive basis NAT products for rapid microbiological and virus monitoring in the biotech and pharmaceutical industries. Microbiological monitoring of
manufacturing processes is critical to ensuring patient safety and meeting regulatory requirements.
For more information, go to: http://www.gen-probe.com/news/PressReleaseText.asp?compid=135117&releaseID=751341.
PROCLEIX® and ULTRIO® are trademarks of Novartis Vaccines and Diagnostics, Inc.
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San Diego, CA 92121
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