Orion is developing a molecular screening test to diagnose lung cancer. The test will detect lung cancer in sputum samples collected from high risk patients and from patients with positive low-dose, non-contrast, spiral, computerized tomography scanning lung cancer screening results.
Orion has patents pending on over 68 novel lung cancer biomarkers discovered and validated in our genome-wide search for cancer biomarkers, 38 of which individually demonstrated greater than 80% sensitivity and 80% specificity, and 7 demonstrated 90% sensitivity and 90% specificity in pilot, retrospective, tissue-based studies in up to 118 patient samples, (see Leading Lung Cancer Screening Biomarkers figure).
In the figure above, the methylation scores of 7 leading lung cancer screening biomarkers are plotted for normal lung samples (green circles) and lung tumor samples (red triangles). Each biomarker correctly identified more than 90% of the tumors and normal patient samples evaluated.
|US screening population:||71.5 million|
|New cases this year:||213,000|
|Deaths this year:||160,390|
|5 yr survival rates:||16%|
|Stage||5 Yr Survival||% Cases|
The high risk group consists of current and past cigarette smokers. Current cigarette smokers make up 24% of adults in the US (or 47.5 million people) and past smokers comprise another 24.1 million adults. This group is greater than twenty times more likely to develop lung cancer than nonsmokers. Additionally, smoking is the primary cause of COPD, a condition that further increases the risk of lung cancer. More than 10 million people in the US have physician diagnosed COPD.
No molecular test is presently on the market to diagnose lung cancer. One of the most sensitive techniques for the detection of lung cancer in high risk patients is low-dose, non-contrast, spiral, computerized tomography scanning (LDCT), which has a high sensitivity (>90%) but suffers from poor specificity. For example, nine false positive results typically occur for each true cancer case identified with LDCT screening of high risk patients.
The Orion Lung Cancer Screening Test is being developed to identify cancer in easily-accessible samples collected from high risk patients, and from patients with suspicious lesions of the lung detected by LDCT. We expect that the high specificity offered by DNA methylation-based biomarkers will greatly improve the existing lung cancer screening paradigm.