LungAlert™ is a novel test that identifies patients at risk of lung cancer at the early stages of the disease. The test detects a cancer-associated sugar in a sample of sputum (phlegm), which is obtained in the doctor’s office by coughing into a cup. Currently, there is no screening test for lung cancer that has proven to save lives. LungAlert™’s attributes position it to be a front-line screening test for this deadly disease. LungAlert™ is:

• Non-invasive;
• Attractive to patients as it does not require dietary restrictions or any other preparation prior to the test;
• Easy to administer, with the sample collected by a physician during a routine check-up; and
• Cost-effective.

In clinical studies, LungAlert™ has demonstrated sensitivity of 50%–75% and specificity of 75%–90% for early-stage cancer.

Lung cancer is the most prevalent cancer in the world. It is also among the most fatal cancers, leading to death 85% of the time. In 2006, the American Cancer Society projects 174,470 new cases of lung cancer and more than 162,460 deaths, representing 29% of all cancer deaths. When diagnosed early, the five-year survival rate is 50%. But just 16% of lung cancers are identified at an early stage.

Early-stage disease usually has few or no symptoms. Symptoms of more advanced disease include chronic cough, coughing up blood and recurring infections such as bronchitis and pneumonia. More than 85% of lung cancer cases can be directly or partly attributed to smoking. Other risk factors include exposure to radon and other industrial carcinogens such as asbestos as well as exposure to second-hand cigarette smoke.

Currently, no diagnostic test for lung cancer has been proven to save lives. The two most common diagnostic tests for lung cancer are chest x-ray and sputum cytology, but, by the time a tumor can be detected with either of these tests, it is often too advanced to treat or has spread to other organs. Emerging tools, such as spiral computed tomography (CT) or positron emission tomography, appear to be more effective at detecting lung cancer but are either too resource intensive or costly to serve as a front-line screening test.

Without question, better screening options are required to reduce the loss of life and economic burden of this deadly disease.

A doctor collects a sample of sputum from the patient by asking him or her to cough into a cup. Most smokers and other people with lung disease can produce sputum spontaneously; for others, sputum can be induced using a saline solution. The sample is then placed on a proprietary membrane and sent to a laboratory.

At the laboratory, the sample is treated with the enzyme galactose oxidase, then stained with Schiff’s reagent, which produces a color change. The treated sample is read with a color reader (spectrophotometer) to quantify the color change and determine the numeric LungAlert™ value.