Frequently Asked Questions From Providers About EarlyCDT™-Lung
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 Early CDT-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 CLIAcertified laboratories in the United States would meet standards of accuracy and reliability.1
The EarlyCDT™ 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 Early CDT-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 Early CDT?”
EarlyCDT™ 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 oncimmune.com, cancer.gov or 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™ 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™ 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™ 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™ 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 Early CDT be reported to my health insurance provider?”
The results will not be sent to your health insurance company unless the patient specifically request it. At this time, Oncimmune® EarlyCDT™ is not covered by health insurance, although patients have a right to talk to their insurance company and attempt to seek coverage. Since patients pay for the procedure out of pocket, the physician is not required to give any information regarding the EarlyCDT™ to an insurance company unless you request a claim be submitted or otherwise authorize such disclosure. You may request that your physician maintain the confidentiality of your results.
What is the expected clinical use of EarlyCDT™–Lung?
EarlyCDT™–Lung is expected to be used as an aid in early detection cancer testing:
- Facilitating further and faster evaluation of patients suspected to have a high probability of lung cancer, with a focus on asymptomatic, high–risk individuals. The sensitity and high specificity of EarlyCDT™–Lung should justify a CT when the result is positive.
- For differential diagnosis and workup when respiratory infection presents in high–risk individuals.
- For further investigation of a pulmonary lesion identified during a screening effort or random chest imaging.
- In concert with CT, EarlyCDT™–Lung may justify a second CT sooner to characterize the dynamic growth of a pulmonary nodule.
- By providing useful information for making decisions concerning nodule/lobe resection.
We are currently completing analyses of our final validation study. The data include nearly 1000 patient samples from both cancer and normal populations. Following anticipated completion in early 2009, the results will be submitted to our Science Advisory Board (SAB) for approval. Once approved, members of the SAB will draft and submit the results for publication to a peer-review journal. We anticipate the process of draft, submission, revision and publication will take approximately 6–12 months. During that time prior to publication, we will offer a limited release of the test in 10–15 sites, which will allow us to work intimately with these select sites before introduction of the test into the broader market.
The Limited Commercial Release is not a clinical study but a controlled pilot release of the test. All testing will be conducted in our Oncimmune® laboratory, which strictly complies with all CLIA regulations. We plan to work in partnership with the 10–15 sites during the Limited Commercial Release to assist them with interpretation of test results and outcomes of EarlyCDT™–Lung, which we anticipate will be a great learning opportunity for Oncimmune® and for physicians.
Sources:
1www.cms.hhs.gov/CLIA
2http://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.”, March 2008, Thorax (online publication), 63(3):228-33,