Lung Cancer FAQs
Lung cancer can be a risk for both men and women. Routine testing can provide important knowledge about your health because the earlier a cancer is detected the better the outlook. Answers to some questions about EarlyCDT™ will help you understand your physician's decision should he or she recommend the test for you.
“What happens to my EarlyCDT™-Lung blood sample?”
The blood sample drawn by your physician is sent to the Oncimmune® laboratory, which operates under Clinical Laboratory Improvement Amendments of 1988 (CLIA) guidelines. Congress enacted CLIA so that all CLIA-certified laboratories in the United States would meet standards of accuracy and reliability.1
The EarlyCDT™-Lung procedure consists of placing a small sample of your blood in contact with surfaces where cancer-associated antigens have been attached. The autoantibodies present in the blood bind to the antigen(s) in the test system and can be detected by the sophisticated instrumentation used in the laboratory. A report is generated and sent to your physician within a week indicating a positive or negative test result.
“When discussing lung cancer and EarlyCDT™-Lung, you refer to symptomatic and asymptomatic individuals. Why?”
Information found at cancer.org and cancer.gov indicates that symptoms of lung cancer, such as a persistent cough, weight loss without cause, shortness of breath, constant chest pain and others, do not appear until the disease has reached an advanced stage. Early detection is your best chance of surviving cancer. People who take advantage of early detection methods like EarlyCDT™-Lung could potentially improve their chances of effective treatment/therapy and survival.2
“Who should be screened for lung cancer using EarlyCDT™-Lung?”
EarlyCDT™-Lung is recommended most often for asymptomatic individuals (those who show no symptoms of lung cancer) who have one or more of the risk factors for lung cancer. It is especially recommended for long-term smokers and ex-smokers who are asymptomatic. Visit www.oncimmune.com, www.cancer.gov or www.cancer.org and talk to your physician to learn more about risk factors.
“Does a negative result mean I don't have to be concerned about lung cancer?”
A negative EarlyCDT™-Lung does not mean you do not have or will not develop lung cancer. No test, including radiological imaging studies, is a foolproof screening method. However, if both diagnostic imaging and EarlyCDT™-Lung are negative, the likelihood is significantly increased that you do not have the disease. Early clinical tests indicate that greater than 98% of patients with a negative EarlyCDT™-Lung do not have lung cancer at the time of testing.3 You should continue the regular schedule of cancer screenings advised by your physician.
“What are the implications of a positive test?”
In the event of a positive EarlyCDT™-Lung result (when one or more of the autoantibodies detected is elevated beyond a certain level) your physician will recommend more tests, such as spiral CT (computed tomography) diagnostic imaging scans, among others, to further identify the presence of disease. If these additional imaging tests do not detect lung cancer, your physician might recommend more frequent examinations, imaging and testing in the future.
Will the fact that I've taken the EarlyCDT™-Lung be reported to my health insurance provider?
At this time, the Oncimmune® EarlyCDT™-Lung is not covered by health insurance, although patients can talk to their insurance company about possible coverage. Patients are currently required to pay for the procedure out of pocket; therefore, the healthcare provider is not required to give any information to an insurance company. In fact, healthcare providers are forbidden by law to share information with insurance carriers about their patients unless the information concerns covered procedures for which a claim has been filed. In this case, healthcare providers are required only to supply a diagnostic code that covers the test procedure. The results of the test are to remain confidential unless the patient agrees to share the information with the insurance company.
Visit www.hhs.gov/ocr/hipaa for more information.
Sources:
1 www.cms.hhs.gov/CLIA
2 http://www.cancer.org/docroot/PED/ped_2.asp?sitearea=ped
3 98% is the negative predictive value of EarlyCDT™. It reflects the number of patients who test negative based on a formula that takes into account true negatives and false negatives. Chapman, C., et al. “Autoantibodies in Lung Cancer—Possibilities for early detection and subsequent cure.” Thorax. 63(3):228-33, March 2008. (online publication).