Early stage lung cancer often is caught by accident via an imaging test for another problem. Screening for lung cancer, typically via chest X-rays or sputum tests, has been unreliable and isn't recommended even for high-risk patients.

Cangen Biotechnologies (Baltimore) and collaborator Dai Nippon Printing (DNP; Tokyo) are aiming to fill that screening and, perhaps diagnostic, void with a clinical trial of a blood-based assay that already has shown promise in a 1,000-patient sample study.

"This is a pretty simple test that uses the DNP proprietary purification systems," Cathy McDermott, RN, vice president of regulatory affairs and technical development at Cangen, told Medical Device Daily. "The beauty of this test is that it could be performed anywhere without sophisticated equipment."

Cangen's technology uses matrix-assisted laser desorption/ionization-time of flight (MALDI-TOF) mass spectroscopy to discover the lung cancer-specific biomarkers.

McDermott said Cangen executives are currently trying to decide whether to develop the test for screening, as a diagnostic or for both.

"Initially, we're looking at using this test as a screening tool for high-risk patients such as smokers and for some patients with certain types of occupational exposure," she said. "Because it's a blood test, it has very good potential utility by primary care physicians or internists." These doctors would use it for all high-risk patients as a normal course of physical exams.

McDermott said the intention is to catch lung cancer at the earliest stages, I and II, as was proven during the recent sample study at multiple sites in South Korea.

"Our next stage in this process is to negotiate with the FDA for an actual trial size," she said, adding the company hopes to have the same number of patients included, "at a minimum."

If all goes well, McDermott said the trial could begin in 2009 and be completed in 2011. "We would hope to be on the market late 2011 or 2012," she said.

To accelerate the project, Cangen will receive a milestone payment as part of the agreement with DNP initiated in March 2007. Further development of the product may lead to additional milestone payments to Cangen toward the funding of a Phase III trial in the U.S. Financial details were not disclosed.

"We're really excited to begin this and we see this as a test that helps to improve the quality of life for people with lung cancer," McDermott said. "We're hoping it will become widely available in the U.S., Europe and Asia."

According to the Centers for Disease Control and Prevention (Atlanta), more people die annually from lung cancer than any other type of cancer. The National Cancer Institute (Bethesda, Maryland) predicts there will be more than 215,000 new cases and more than 160,000 deaths from lung cancer (non-small cell and small cell combined) in the U.S. in 2008.

In recent years, spiral computed tomography (CT) scanning has shown some promise in finding early lung cancer in smokers and former smokers. But it is not yet known if this test will lower the chances of dying from lung cancer. One major problem is that it finds a lot of things that turn out not to be cancer. This leads to unnecessary tests and even surgery.

An ongoing observational study has found that lung cancer can be detected at its very earliest stage in 85% of patients using annual low-dose CT screening. The study was launched by a team of researchers at NewYork-Presbyterian Hospital/Weill Cornell Medical Center (New York) in 1993 and has expanded into an international collaboration of 38 institutions in seven countries. The International Early Lung Cancer Action Project (I-ELCAP) is the largest, long-term study to determine the usefulness of annual screening by CT (MDD, Oct. 30, 2006).

Another study, called the National Lung Screening Trial, is comparing CT with standard chest X-rays. This study will aim to show if either test is better at reducing deaths from this disease (MDD, Dec. 29, 2005).