Lung cancer kills almost 160,000 Americans each year, making it the number one cancer killer in the U.S. One of the reasons lung cancer is so deadly is that it has been all but impossible to detect the disease early.
However, that may be changing now with the advent of EarlyCDT™-Lung, a test that measures autoantibodies in blood that are produced by the body in response to tumor antigens produced by cancer cells at the earliest stages of the disease before tumors show up on a CAT scan.
According to Dan Calvo, CEO of Kansas-based Oncimmune® LLC, the developer of the test, "there is a large body of work that supports the Oncimmune test premise that autoantibodies to lung cancer antigens arise at the earliest stages of the disease and are present in sufficient quantity to be measured."
Over the past 15 years, John Robertson, Professor of Surgery in the Faculty of Medicine & Health Sciences at the University of Nottingham and Oncimmune's Chief Scientific Officer, has conducted groundbreaking research into the body's immune response to cancer. Oncimmune is developing other commercial products like EarlyCDT-Lung based on his work. EarlyCDT-Lung has undergone rigorous testing in the past five years and has proven to provide specific results. "Our test has seven times fewer false positives than CT and has 93 percent specificity," Calvo says.
The EarlyCDT-Lung must be used in conjunction with CT imaging because physicians need to know where the tumor is located. "CT followed by EarlyCDT-Lung is a great one-two punch for the early detection of lung cancer," Calvo says.
James Jett, MD, of National Jewish Health and a member of CEAC's external advisory board, says that data indicates that the EarlyCDT-Lung test can risk stratify normal vs. malignant nodules. "Early diagnosis of lung cancer before it has spread, and therefore while curable, remains the goal for our screening tests. The EarlyCDT-Lung test is a new technology with the potential to shift our ability to diagnose lung cancer earlier than is currently achieved," Jett says.
Pulmonary specialist Allan Goldstein, MD, of Pulmonary Associates of the Southeast, P.C. in Birmingham uses EarlyCDT-Lung and sees the specificity of the test as a positive step in the fight against lung cancer. He uses the test as a follow up for people with indeterminate lung nodules. "This test gives us another weapon in our arsenal to treat lung cancer patients. Because false positives can cause unnecessary invasive treatment, we can be more certain that a lesion is cancer when the EarlyCDT-Lung test results indicate it," Goldstein says. "We want to get the most information we can to avoid invasive treatment and the earlier we determine the diagnosis, the better chance for successful treatment."
High-risk individuals such as long-term smokers and ex-smokers between the ages of 40 and 75 along with individuals with other risk factors such as environmental exposures and extensive exposure to secondary smoke are candidates for the test.
"It is common for us to order EarlyCDT-Lung if CT shows a possible lesion, but if a patient who has a family history of lung cancer or a history of smoking asks for the test, we will do it," Goldstein says. "EarlyCDT-Lung is not a screening test and shouldn't be looked at as a screening tool. We use it when we have a suspicion of cancer."
There are both medical and economic benefits to the use of EarlyCDT-Lung. Goldstein says there will be medical benefits because people will get surgery earlier, and less tissue will be removed in most cases. "When physicians treated lung cancer years ago, they initially removed whole lungs. Later they removed lobes. Now we can take a piece of tissue through a fluoroscope with just a small incision," he says. "For the patient, EarlyCDT-Lung can mean an easier treatment process and less time in the hospital, and the patient loses less functional tissue. We have this test, so let's use it and use it wisely."
In determining economic benefits, Oncimmune researchers have estimated a $6,000 potential cost savings for every QALY (quality-adjusted life year). The test is covered by private insurance and Medicare. "The management of most lung cancer patients comes in the late stages of the disease with approximately 85 percent of patients being diagnosed at Stage Three or later," Calvo says. "Treatment at that stage is complex and expensive when you consider surgery, chemotherapy, and radiation. By finding cancers earlier, treatment is often simpler and less expensive."
The physician-ordered EarlyCDT-Lung test is available in 49 states, and more than 600 physicians across the country currently use the test on a regular basis. Physicians can order the test materials online at www.oncimmune.com. Education materials also are available on the site.
Calvo is excited about what the development of EarlyCDT may mean to the detection and treatment of other types of cancer. "The autoantibody platform used in EarlyCDT-Lung is available now. We just need to identify and validate the different markers for different cancers," Calvo says. Oncimmune plans to adapt the technology to the development of blood tests for a variety of solid tumor cancers. A test for breast cancer is in the late stages of development, and researchers are completing studies on ovarian, prostate, esophago-gastric, colon, and liver cancers.
"We have a big vision here at Oncimmune," Calvo says. "This pioneering work is not easy, but we all believe in it or we would not be doing it."