U.S. Genomics And Lahey Clinic Announce Collaboration To Study The Role Of MicroRNAs In The Prognosis Of Urologic Cancers

WOBURN, Mass., Oct. 19 /PRNewswire/ -- U.S. Genomics Inc. and Lahey Clinic announce the signing of a discovery agreement to study the role microRNAs play in the development of urologic cancers. The objective of the collaboration is to develop more accurate prognoses for bladder and prostate cancer patients. The collaboration combines U.S. Genomics’ patented Trilogy(R) 2020 platform and Direct(TM) miRNA assay with Lahey Clinic’s expertise in the analysis of tumor progression and experience in disease management.

“This collaboration is intended to expedite the development of next-generation molecular diagnostic tests to determine the prognosis of several major urologic cancers,” said John Libertino M.D., Chairman of the Department of Urology, Lahey Clinic.

“MicroRNAs hold great promise as biomarkers for several disease states, and we are very pleased to be working with U.S. Genomics to explore these new diagnostic markers for urologic oncology patients,” said Ian Summerhayes, Ph.D., Executive Director of Research, Lahey Clinic Medical Center.

“U.S. Genomics is excited about working with Lahey Clinic to study the potential for microRNA-based tests for the prognosis of bladder and prostate cancer,” said John Canepa, CEO and President of U.S. Genomics. “Use of our Trilogy(R) 2020 single molecule detection platform and assays partnered with Lahey Clinic’s unique expertise and the guidance of Drs. Libertino and Summerhayes has the potential to result in significantly more accurate prognostic tests for these diseases,” added Duncan Whitney, VP, Research & Development (U.S. Genomics).

Bladder Cancer

In the United States, bladder cancer will be diagnosed in more than 61,000 patients by the end of 2006 and there will be more than 13,000 deaths from this disease. Bladder tumors fall into two broad categories characterized by low-grade papillary tumors, which are usually superficial, and high-grade tumors that are often invasive. Clinically, superficial bladder tumors account for 75-80% of the cases, while the remaining 20-25% are invasive or metastatic at the time of presentation. More than 70% of patients affected with superficial tumors will have multiple recurrences and approximately one-third will progress, presenting at a later date with a more aggressive lesion. At present there are no accurate tests to predict which non-invasive forms may become invasive. Invasive forms have a much higher mortality rate and molecular tests based on miRNA signatures are expected to yield more informative indications than existing tests.

Prostate Cancer

Current methods for evaluating prognosis in prostate cancers remain imperfect, leading to unnecessary medical procedures. This year in the United States there will be 234,460 newly diagnosed prostate cancer cases and approximately 30,000 men will die from the disease. As with many solid tumors, early diagnosis results in a relatively high cure rate, which diminishes significantly when prostate cancer escapes beyond the confines of the gland. However, uncertainty in pathological analysis of biopsies creates the need for more informative indicators of disease progression and metastases. It is believed that miRNA assays, can be effective in differentiating the transition phenotype characterized by the acquisition of invasive potential.

About microRNAs

MicroRNAs (miRNAs) are recently discovered, naturally occurring small RNAs that act as regulators of protein translation. Because many diseases are caused by the misregulated activity of proteins, detection of endogenously expressed elements that regulate the production of important disease-specific proteins, such as miRNAs, become important indicators of disease, and disease progression. The ability to accurately and precisely measure expression levels of specific miRNAs has become an important criterium in both disease research and diagnostics. Detection of miRNAs using single molecule detection and Trilogy 2020 provides methods for direct and sensitive quantitation without the need for amplification of targets.

About U.S. Genomics

U.S. Genomics is pioneering single molecule biology technologies for life science and biodefense applications by combining advances in microfluidics, optics, engineering, and novel molecular labeling strategies. Using its DNA mapping technology, the Company is developing sophisticated biosensors for the detection and identification of pathogens and biomarkers in the air, human serum and other biologically relevant materials. The Company’s biodefense focus on airborne pathogens has been funded in part by $26 million in contracts from the U.S. Department of Defense and the U.S. Department of Homeland Security. The Company’s Trilogy(R) 2020 platform enables the direct detection and analysis of individual molecules of DNA, RNA, and proteins without the need for amplification. U.S. Genomics’ portfolio of products will further a greater understanding of genetics and disease pathways and will ultimately lead to more effective therapeutics, diagnostics, and biodefense solutions. For more information about U.S. Genomics, please visit http://www.usgenomics.com.

Trilogy(R) is a registered trademark and Direct(TM) (as in Direct miRNA) and U.S. Genomics(TM) are trademarks of U.S. Genomics, Inc.

About Lahey Clinic

Lahey Clinic, a physician-led, nonprofit group practice, is world-renowned for innovative technology, pioneering medical treatment, and leading-edge research. A teaching hospital affiliated with Tufts University School of Medicine, the Clinic provides quality health care in virtually every specialty and subspecialty, from primary care to cancer diagnosis and treatment to kidney and liver transplantation. For more information, please visit our Web site at http://www.lahey.org

U.S. Genomics Inc.

CONTACT: Rose Lewis of Lahey Clinic, Mgr, Media Relations,+1-781-744-5440; or John Canepa, CEO of U.S. Genomics Inc.,+1-781-939-6424, jcanepa@usgenomics.com

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