It is a simple blood test that can aid in the risk assessment and early detection of lung cancer.

EarlyCDT–Lung is a simple blood test drawn at the physician’s office or at an off-site draw station. The sample is sent for testing to Oncimmune’s laboratory located in the Metro Kansas City area. The blood sample is analyzed on a multi–antigen panel. During the process, highly–qualified and thoroughly–trained technicians perform numerous steps to measure the presence of autoantibodies associated with tumor antigens (immuno–biomarkers). The antibodies are produced by the immune system in the earliest stages of the disease and can be used to aid in the early detection of cancer. The ordering physician will receive a comprehensive report of EarlyCDT–Lung results in about one week after receipt of sample.

Contact Client Services at 1–888–583–9030 or sign up now.

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.

No. All of the information is not 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 and time of collection

• Dates

• Patient signature

• Medicare or Insurance information, if applicable

• Credit card information, if applicable

• Question 5 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.

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 you carrier for reimbursement. We are required to supply a diagnostic code (ICD–9 Code) which is supplied by your healthcare provider and 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.

EarlyCDT-Lung is covered by Medicare and private insurance.  Oncimmune will offer financial assistance if you are uninsured or have Medicaid.  We will accept major credit cards, a money order, personal check or cashier’s check as payment.  Please contact Client Services at 1–888–583–9030 or email clientservices@oncimmune.com for more details.

We suggest indicating that the results are positive or negative and providing the “Understanding Your Results” page that comes with the Results 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.

At this time, the data does not support such an interpretation of relative levels with respect to positivity or negativity.

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.

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.

EarlyCDT–Lung is designed to be used in conjunction with diagnostic imaging which is required for localizing a potential tumor, including CT, X–ray and PET scanning. Based upon the results of these imaging tests and other tests that may be included such as sputum cytology and/or bronchoscopy, a biopsy is the only definitive diagnostic procedure to confirm the presence and stage of lung cancer.

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 tobacco smokers (20 pack years) including pipe, cigar, and cigarettes including second–hand smoke
• Long–term marijuana smokers (20 pack years) including pipe, cigar, and cigarettes including 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
• Shortness of breath during normal activity

If you would like to know more about lung cancer risks, please visit our website at www.oncimmune.com, the National Cancer Institute’s website at www.cancer.gov, or the American Cancer Society at www.cancer.org for more information.

The lung cancer early detection test is covered by Medicare and private insurance.  For those who are uninsured, or have Medicaid, Oncimmune will accept most major credit cards, a money order, personal or cashier’s check as payment.

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.

The test is reported to the physician as either a negative or 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.

A negative result does not indicate the patient does not have cancer, nor does it alter the risk of the patient. A patient with a negative result should still be evaluated carefully and monitored regularly as the patient is still at high risk for lung cancer.