The Maryland-based 20/20 GeneSystems, Inc ("20/20") announced study results showing that its multibiomarker blood test may be able to detect non-small-cell lung cancer (NSCLC) significantly earlier and with better accuracy than computed tomography (CT) scans, the most advanced technique in current use for detecting the 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 a recent issue of the Journal of Thoracic Oncology (1:513-519, 2006).

'Compelling Need for Tools'

Last year, 20/20 obtained exclusive rights to the blood test from the University of Kentucky, and the company is codeveloping it with a research team from the University's division of pulmonary and critical care medicine, led by Edward Hirschowitz, MD, and Li Zhong, PHD. 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 of 20/20. "Currently, only 25% 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."

Improved Sensitivity/Specificity

Researchers used panels of antibodies generated by the body's immune system in response to very early-stage NSCLC. Their study 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 to 5 years before reaching the conventional size limits needed for diagnosis by current radiographic screening methods (0.5 mm). In this particular investigation, researchers used blood that was 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 noncancer controls whereas CT screening has a false-positive rate of more than 50%."

Novel Approach

"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."

The University of Kentucky and 20/20 jointly received a $175,000 grant from the National Institutes of Health in support of the development of this lung cancer assay.