UK working with 20/20 GeneSystems

December 16, 2005

LEXINGTON, Ky. (Dec. 15, 2005) − The University of Kentucky has granted exclusive rights to 20/20 GeneSystems Inc. (20/20) for a new blood test that has shown exceptional accuracy for the early detection and screening of non-small cell lung cancer (NSCLC). Working with the UK team, the company 20/20 intends to develop a diagnostic that would help identify lung cancer in smokers, former smokers and other at-risk individuals at its earliest, most effectively treatable stages.

Edward Hirschowitz, M.D., and Li Zhong, Ph.D., of the Division of Pulmonary and Critical Care Medicine, UK Chandler Medical Center, along with several associates, have identified multiple antibodies that the body's immune system produces in response to lung cancer development. The presence and amounts of these antibodies in the blood predict NSCLC with better than 90 percent accuracy, including at very early stages of the disease. NSCLC comprises approximately 80 percent of all lung cancers.

Part of this research was reported in the November 2005 issue of the American Journal of Respiratory and Critical Care Medicine, published by the American Thoracic Society. While the published work primarily involved samples from patients with advanced disease, subsequent tests on blood from persons with early-stage lung cancer detected cancerous nodules several years before they were identified using advanced CT scans. This new data directed to early detection and screening is expected to be presented in early 2006 to the National Cancer Institute (NCI) Early Detection Research Network.

According to the NCI, 160,000 people die each year from lung cancer, making it the number one cause of cancer death in America. Smoking is the primary cause of the disease. Only 25 percent of new cases of lung cancer are diagnosed at an early stage, when curative surgery is possible.

With the biomarkers identified by the UK team, 20/20 plans to create a screening test for the early detection of lung cancer using its proprietary layered peptide array (LPA) platform. "Our goal is to create the first accurate blood test for detecting lung cancer in its early, most treatable stages," said Jonathan Cohen, president and CEO of 20/20 GeneSystems Inc.

"UK's partnership with 20/20 will allow our researchers to be part of this important lung cancer screening breakthrough," said UK Executive Vice President for Research Wendy Baldwin.

The Kentucky team used a novel approach in developing the test. Rather than looking for a single protein antigen as with the widely administered prostate-specific antigen (PSA) test, which has limited sensitivity and specificity, they instead identified a group of antibodies that the patient's immune system generates very early in the development of tumors. This is the same technical approach used by the team developing a new prostate cancer test reported in The New England Journal of Medicine on Sept. 22 of this year.

"This outstanding research will be integrated into our novel lung cancer screening program at the UK Lucille P. Markey Cancer Center," said Dr. Alfred Cohen, cancer center director. "We're very proud of Dr. Hirschowitz, who is a member of our Tumor Immunology and Immunotherapy Program."

"We are very excited about working with 20/20 to bring this needed technology to market in a timely manner," said Hirschowitz.
-end-
20/20 GeneSystems (www.2020gene.com) was founded in 2000 and is based in Rockville, Maryland. It is focused on the development of innovative protein biomarker-based diagnostics for biodefense, cancer and autoimmune diseases. It presently has one product on the market for use in biodefense.

In striving to become a Top 20 public research institution, the University of Kentucky is a catalyst for a new Commonwealth - a Kentucky that is healthier, better educated, and positioned to compete in a global and changing economy. For more information about UK's efforts to become a Top 20 university, please go to http://www.uky.edu/OPBPA/Top20.html

University of Kentucky

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