What is EarlyCDT–Lung?
A simple physician-order blood test to aid in risk assessment and the early detection of lung cancer in high-risk patients.
How does it work?
When a tumor is present it produces abnormal proteins not normally found in the body, known as antigens. The body reacts rapidly to abnormal antigens by producing antibodies. Our test measures a panel of autoantibodies to detect the presence of lung cancer.
Where is the sample for EarlyCDT–Lung sent for testing?
The sample is sent to Oncimmune’s CLIA–certified laboratory located in the Metro Kansas City area for testing, analysis, and reporting. Oncimmune will cover the cost of the overnight FedEx shipment and shipping materials. A collection kit will be provided with the necessary instructions and materials for shipment.
Who should be tested for lung cancer using both EarlyCDT–Lung and diagnostic imaging?
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 include:
- Long-term smokers or former smokers, 20 pack years or more
- Family history of lung cancer or extensive exposure to second-hand smoke
- Extensive exposure to environmental factors like radon, asbestos, coal products and radioactive substances
- Presence of an indeterminate pulmonary nodule
- Patient should have no previous personal history of cancer
If you would like to know more about lung cancer risks, please see our website, the National Cancer Institute website at cancer.gov, or the American Cancer Society website at www.cancer.org for more information.
Why does the EarlyCDT–Lung panel contain specific autoantibodies?
The antigens in the EarlyCDT-Lung panel have been selected for their involvement in the early stages of the development of tumor formation and have been validated for the early detection of that particular cancer. Due to the heterogeneous nature of cancer, the test to detect cancer is greatly enhanced by the combination of autoantibodies.
Which autoantibodies are measured by the test?
- CAGE
- GBU4-5
- HuD
- MAGE A4
- NY-ESO-1
- p53
- SOX-2
Is one antigen on the test panel more relevant to disease diagnosis than another?
If one or more of the autoantibodies to a specific antigen are present at a level above the cutoff value, then the result is positive and may indicate the presence of the disease.
How are the patient results reported?
The test is reported as either a negative (Negative or Low Negative) or positive (Positive or High Positive) result via facsimile, mail, or through the physician's online portal. Client services will confirm with the ordering physicians’ office the secure method of reporting Protected Health Information (PHI). The report may come back invalid which means we were unable to determine the result for this autoantibody. All other autoantibodies remain valid. The test report will include the results for all of the measured autoantibodies.
What do I do with a positive result?
A positive test result means autoantibodies have been detected above a predetermined cutoff. Based on a positive test result, the patient has an increased risk for having lung cancer. Additional monitoring for lung cancer is recommended, including imaging with low dose CT, consistent with the patient's history and overall risk profile which may include prior radiological findings. For lung nodules continue to follow recommended guidelines, such as the Fleischner Guidelines. A positive result may suggest an earlier use of imaging in accordance with these guidelines. Consult Oncimmune's medical staff via Client Services at 1-888-583-9030.
What do I do with a negative result?
A negative result does not mean the patient does not have some continuing risk of lung cancer. They are still at risk for lung cancer due to their risk factors. Continued monitoring is recommended consistent with the patient's history and overall risk profile.
What is the best way to share test results with my patient?
We suggest providing the “Understanding Your Results” page that comes with the Laboratory Report, explaining what these results mean, and what follow–up is appropriate. Oncimmune’s medical director and/or physician staff are available for consultation or to answer any clinical questions regarding EarlyCDT–Lung results.
When can I expect to receive the EarlyCDT–Lung results?
You can expect the test results to be sent to you in about a week of the Oncimmune laboratory receiving the sample from the draw station. Oncimmune releases test results only to the healthcare provider, not to the patient.
EarlyCDT–Lung and your insurance:
Oncimmune will bill the insurance provider for the test if you have Medicare Part B as your primary insurance OR if you have private health insurance coverage. At the time that your blood sample is collected, please complete the Medicare or insurance information requested on the test requisition form. For either type of coverage, please also include a legible copy (front and back) of your insurance card with the sample which is sent back to Oncimmune.
If you do not have either type of insurance coverage noted above, payment is required at the time you provide your blood sample. There is a payment envelope included in the collection kit materials provided. Oncimmune accepts credit cards, checks, or money orders. Financial assistance is available if you are covered under Medicaid or are uninsured. Out-of-pocket expenses may be eligible for reimbursement if you have an employer-provided Flexible Spending Account (FSA) OR Healthcare Spending Account (HSA). You should verify the specifics of your plan if this option is available to you.
Please contact Client Services at 1–888–583–9030 or email clientservices@oncimmune.com
Will the fact that I’ve taken the EarlyCDT-Lung be reported to my health insurance provider?
If you have private health insurance or if you are covered under Medicare Part B as your primary insurance, Oncimmune will file a claim to your carrier for reimbursement. We are required to supply a diagnostic code (ICD-9 Code) which is supplied by your healthcare provider and a test procedure code (CPT Code) that covers the EarlyCDT-Lung test procedure. Oncimmune will provide the lab test report to the carrier only if requested by the carrier in their determination of reimbursement to us. Otherwise, the results of the test remain confidential unless the patient agrees to share the information. Visit www.hhs.gov/ocr/hipaa for more information.
Do you accept payment arrangements?
Yes, we can offer payment arrangements for self-pay patients who need financial assistance. Please contact our Client Services Department at 1-888-583-9030 for further details. Patients outside of the U.S. would need to pay in full at the time the sample is submitted for testing.
How do I become a provider for EarlyCDT–Lung?
Contact Client Services at 1–888–583–9030 or sign up now.
Are all the questions on the requisition form required to complete the test?
No, not all of the information is required; however, answering the questions honestly and completely is recommended to help us and your physician better serve you. The required fields are:
- Physician signature
- Collection site information including date of collection
- Dates
- Patient signature Medicare or insurance information, if applicable
- Credit card information, if applicable
- Question in the Clinical History section, “Have you ever been diagnosed with any type of cancer?”
Oncimmune strongly encourages patients to fill out all Patient Clinical History thoroughly