20/20 GeneSystems Acquires Rights to Lung Cancer Screening Test from U. Kentucky; Company to Develop Blood Test to ID Tiny, Treatable Tumors.

ROCKVILLE, Md. -- 20/20 GeneSystems, Inc. ("20/20") today announced that it has acquired exclusive rights from the University of Kentucky to 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 team from Kentucky and other leading medical and scientific groups the company 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.

"We are very excited by the innovative work being done here in Montgomery County and 20/20 GeneSystems continues to be a leader in our biotech community," said County Executive Douglas M. Duncan. 20/20 GeneSystems is headquartered in one of the County's high-tech business incubators, the Maryland Technology Development Center.

"Just as with their previous work with the BioCheck test, this new collaboration with the University of Kentucky will have great public health implications and has the potential to save thousands of lives."

Edward Hirschowitz, M.D. and Li Zhong, Ph.D. of the Division of Pulmonary and Critical Care Medicine, Chandler Medical Center, University of Kentucky, Lexington, along with several associates, have identified panels of 5-10 antibodies generated by the body's immune system in response to very early stage NSCLC. The presence and amounts of these antibodies in the blood predicts NSCLC with better than 90% accuracy. NSCLC comprises approximately 80% of all lung cancers.

Part of their research was reported in the second issue of November 2005 of the American Journal of Respiratory and Critical Care Medicine, published by the American Thoracic Society(1). 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 U.S. National Cancer Institute (NCI)'s 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. Presently, 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 University of Kentucky team 20/20 plans to create a screening test for the early detection of lung cancer using its proprietary layered peptide array (LPA) platform. That technology, co-developed with the NCI and recently described in the Journal of Molecular Diagnostics, permits multiple autoantibodies to be screened in multiple patient samples in parallel(2). "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.

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 September 22.

"We are very excited about working with 20/20 to bring this needed technology to market in a timely manner," said the University's Edward Hirschowitz.

About 20/20 GeneSystems

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. The company has received support from Montgomery County Maryland, and the State of Maryland's DBED, TEDCO, MdBIO and MIPs programs. For more information on the company, please call 240-453-6343.

(1) Am. J. Respir. Crit. Care Med. Vol. 172 pp 1308-1314 (2005)

(2) J. Mol. Diag. Vol.7, No. 4 (Oct. 2005)