ROCKVILLE, Md.--(BUSINESS WIRE)--July 14, 2006--Today, 20/20 GeneSystems, Inc. ("20/20") announced study results that show that its multi-biomarker blood test may be able to detect non-small cell lung cancer (NSCLC) significantly earlier and with better accuracy than CT scans, the most advanced technique in current use for detecting this disease. If the reliability of the test can be confirmed on larger numbers of patient samples, the company will seek to introduce what would be the first new blood screen for any cancer since the prostate-specific antigen (PSA) test was introduced in the 1970s. Study findings were published in today's Journal of Thoracic Oncology.
Last year 20/20 obtained exclusive rights to the blood test from the University of Kentucky and is co-developing it with a research team from the institution led by Edward Hirschowitz, M.D. and Li Zhong, Ph.D., of the University of Kentucky, Division of Pulmonary and Critical Care Medicine. The teams are seeking 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.
"Our goal is to successfully create the first accurate blood test for lung cancer that can detect the disease years earlier than the current gold standard," said Jonathan Cohen, president and CEO, 20/20. "Currently, only 25 percent of non-small cell lung cancer is diagnosed at an early, curable stage. There is a compelling need for tools that lead to the detection of lung cancer in its earliest, most treatable stages."
Researchers used panels of antibodies generated by the body's immune system in response to very early stage NSCLC. The studies found that the presence and amounts of these antibodies in the blood predicted NSCLC with about 85% accuracy. Based on the study, researchers estimated that lung cancer may be present 3-5 years before reaching the conventional size limits needed for diagnosis by current radiographic screening methods (0.5 mm). In this particular study, researchers used blood taken from patients several years before their tumors were picked up using CT scans.
"The data generated to date suggests that our panel delivers better combined sensitivity and specificity for detecting NSCLC than any other combination of biomarkers reported in the literature," said Zhong, lead author of the study.
"Clearly the specificity is far superior to CT scanning and chest X rays as our test correctly ruled out cancer in more than 87% of the non-cancer controls whereas CT screening has a false positive rate of more than 50%." (To note: the PSA test is only between 18-36 percent accurate as a screen for prostate cancer; the conventional Pap test is 75 percent accurate in identifying cervical cancer; and the mammogram is about 33 percent accurate in detecting invasive breast cancer.)
Early Detection of Lung Cancer
Lung cancer is the leading cause of cancer death for both men and women in the United States and many other nations. The number of deaths from this disease has risen annually over the past five years to nearly 164,000 in the U.S. alone. This exceeds the death rates from breast, prostate, and colorectal cancer combined.
Many experts believe that early detection of lung cancer is key to improving survival. Past studies indicate that when the disease is detected in an early, localized stage and can be removed surgically the five-year survival rates can reach 85 percent. But these survival rates decline dramatically after the cancer has spread to other organs, especially to distant sites, whereupon as few as 2 percent of patients survive five years. Unfortunately, lung cancer is usually asymptomatic until it has reached an advanced stage. However, only 15% of lung cancers are found at an early, localized stage.
Chest X-rays and computed tomography (CT) scanning have been studied as potential screening tools to detect early stage lung cancers. Unfortunately the high rate of false positives renders these radiographic tools impractical for widespread use.
"The University of Kentucky team used a novel approach in developing the test," said Cohen. "Rather than looking for a single protein antigen as with the widely administered 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, 2005.
Also this week, 20/20 and the University of Kentucky jointly received a $175,000 grant from the National Institutes of Health in support of the development of this lung cancer test.
About the 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. For more information on the company, please call 240-453-6343.
20/20 GeneSystems, Inc.
Jonathan Cohen, 240-453-6343
Pamela Lippincott, 202-955-6222
Source: 20/20 GeneSystems, Inc.