EarlyCDT®-Lung Frequently Asked Questions section
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.
Please do not forget to go through general EarlyCDT® FAQ section.
What is EarlyCDT®-Lung?
It is a simple, blood test that can aid in the risk assessment and early detection of lung cancer.
How does EarlyCDT®-Lung work?
EarlyCDT®-Lung is a simple blood test. The sample is sent for testing to Oncimmune's laboratory located in the Kansas, USA. The blood sample is analysed on a multi-protein panel. During the process, highly-trained technicians perform numerous steps to measure the presence of autoantibodies associated with tumour antigens (immuno-biomarkers). The antibodies are produced by the immune system in response to tumour cells and can be used to aid in the early detection of cancer. Your GP/healthcare provider will receive a comprehensive report of EarlyCDT®-Lung results in about two weeks after sample is drawn.
Once I have received the EarlyCDT®-Lung kit, what do I do?
EarlyCDT®-Lung is blood test. Please follow these simple steps below:
- book an appointment with your GP
- bring the whole kit with you to your appointment
- ask GP for approval to take EarlyCDT®-Lung test
- have your blood drawn (follow Sample Collection Instruction)
- pack your blood sample to Royal Mail SafeBox (follow Safebox Instruction)
- your GP should post a SafeBox to Oncimmune
- we are going to inform you as soon as results are going to be with your GP
- book an appointment with GP to discuss the results
Where can I go to get EarlyCDT®-Lung?
The test is performed on your blood sample in Oncimmune`s laboratory. All you need to do is to order a test on our website (Order a test!) to proceed to the next steps, which involve approval from your GP and having a blood sample taken. Please call Oncimmune on +44 (0)115 82 31869, fax: +44 (0)115 82 31958 or send an email contact. if you have any questions regarding the process.
What happens to my EarlyCDT®-Lung blood sample?
The blood sample drawn by your GP 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.
The EarlyCDT®-Lung procedure consists of placing a small sample of your blood in contact with surfaces where cancer-associated proteins have been attached. The antibodies present in the blood bind to the protein(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 GP within 2 weeks after the sample is drawn, indicating a positive or negative test result.
What is the cost for EarlyCDT®-Lung?
EarlyCDT®-Lung is a self-pay test. You may consult your private health care provider to see if they will reimburse you for this test.
Where is the sample for EarlyCDT®-Lung sent for testing?
The sample is sent to Oncimmune's CLIA-certified laboratory located in the Kansas, USA for testing and reporting.
Why does the EarlyCDT®-Lung panel measure specific autoantibodies?
The antigens in the EarlyCDT®-Lung panel have been selected for their involvement in the early stages of tumour formation and have been validated for the early detection of lung cancer.
When discussing lung cancer and EarlyCDT®-Lung, you refer to symptomatic and asymptomatic individuals. Why?
Information found at Cancer Research UK 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 while still asymptomatic could potentially improve their chances of effective treatment/therapy and survival.
How soon should I have my sample taken after purchasing EarlyCDT®-Lung online?
The time frame from ordering the test and having blood drawn for testing is a decision you should make in consultation with your doctor. There are no definitive time restrictions on when you should take the test. The initial payment is design to cover the cost of test kit and its shipment. The second payment will be taken after the blood is drawn. We estimate allowing 2 weeks for the doctor to receive the test result(s) once the sample is drawn. (Each patient's situation and sample is unique, and therefore, test results cannot be guaranteed by a specific date).
Am I considered at increased risk for lung cancer?
It is recommended that you speak to your doctor about your medical history associated with lung cancer risk factors. Please visit the risk factors and lung calculator section of our website - Risk and Lung Cancer to find out more information regarding cancer risk factors, or you can download a Patient Education Brochure that will explain risk factors and testing options that you and your doctor can discuss together.
What do sensitivity, specificity and reproducibility mean?
The sensitivity of a test such as EarlyCDT®-Lung depends on its ability to identify its target, in EarlyCDT®-Lung's case, autoantibodies to a cancer-associated protein, even at very low levels. The test must also be able to identify autoantibodies specific to the cancer-associated proteins (specificity). Finally, the test must produce the same results over and over under the same set of circumstances (reproducibility). Our validation studies indicate that the overall accuracy of the test is greater than 90%.
Who should be tested for lung cancer using both EarlyCDT®-Lung and diagnostic imaging?
Men and women of any age might benefit from a combination of EarlyCDT®-Lung and diagnostic imaging; however, it is most often recommended for individuals of age 70 or under who have one or more of the risk factors for lung cancer. These risk factors include: The test should be carried out based upon your assessment of the patient, typically 40-75 years of age, having one or more of the risk factors for lung cancer. These risk factors (place for weblink to risk factors page and risk calculator) include:
- Long-term tobacco smokers (20 pack years(see next question for definition of pack years)) including pipe, cigar, cigarettes and second-hand smoke
- Long-term marijuana smokers (20 pack years) including pipe, cigarettes and second-hand smoke
- Prolonged exposure to chemicals such as arsenic, vinyl chloride and other known carcinogens
- Scarring of the lungs due to tuberculosis
- Prolonged exposure to environmental factors such as radon and asbestos
- Recurring pneumonia and/or bronchitis
What does a "pack year" mean?
Pack year is a quantification of cigarette smoking. Calculation of pack years is a way to measure the amount a person has smoked over a long period of time. It is calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked. For example, 1 pack year is equal to smoking 20 cigarettes per day for 1 year, or 40 cigarettes per day for half a year, and so on.
Why should I be screened for lung cancer with both EarlyCDT®-Lung and diagnostic imaging?
EarlyCDT®-Lung is designed to be used in conjunction with diagnostic imaging including CT, X-ray and PET scanning, which is required for localising a potential tumour.
When can I expect to receive the EarlyCDT®-Lung results?
You can expect the test results to be sent to your doctor in about 2 weeks after the sample was taken. Oncimmune® releases test results only to the healthcare provider. Your doctor will present and discuss results with you.
Does a negative result mean I don't have to be concerned about lung cancer?
A negative EarlyCDT®-Lung result means that the test did not detect antibodies that are associated with a specific tumour. A negative EarlyCDT®-Lung does not mean you do not have or will not develop lung cancer. No test, including radiological imaging, 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. You should continue the regular schedule of cancer screenings advised by your doctor.
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 doctor 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 doctor might recommend more frequent examinations, imaging and testing in the future.
What do I do if my test result is negative?
If your result is negative, your health-care provider will probably recommend that you continue your regular schedule of testing and examination. A negative test does not mean that you do not have lung cancer, remember that you still might be in high risk group.
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).