A simple, affordable blood
test for the early detection of
lung cancer

 

EarlyCDT®—Lung is an extensively validated test for the levels of seven autoantibodies to tumour-associated antigens. It can detects all types of lung cancer at all stages of disease (I-IV) with high accuracy.

 

Pulmonary Nodule Risk Assessment

EarlyCDT—Lung positive results may reclassify clinicians’ assessment of cancer risk in pulmonary nodules with new independent data to enable earlier intervention with a low rate of harm.

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Lung Cancer Screening


Early
CDT—Lung
 can be used to detect lung cancer early, in high-risk patients. An ongoing NHS clinical trial has demonstrated a stage shift of 55% to early-stage disease.

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Extensively Studied and Validated

  • Over 25 peer-reviewed clinical publications
  • More than 60 peer-reviewed oral and poster presentations at key conferences
  • Clinically validated in seven independent cohorts and more than 120,000 patient samples, generating 12 million data points
  • Clinically audited in 1600 patients
 
  • Optimised for use in indeterminate pulmonary nodules
  • Meets all the American Thoracic Society criteria for clinical utility for biomarker test use to risk stratify pulmonary nodules
  • Over 155,000 commercial tests run in our CLIA-certified laboratory in Kansas, USA
 
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How EarlyCDT—Lung works

EarlyCDT—Lung measures blood levels of a panel of seven autoantibodies to tumour-associated antigens that are linked to lung cancer.  

The seven autoantibodies have been shown to be elevated for all types of lung cancer, and from the earliest stage of the disease.1,2 Unlike the tumour antigens themselves, the autoantibody levels can be measured easily and accurately, based upon the signal magnification created by the body’s immune response to cancer.  

EarlyCDT—Lung can detect lung cancer as many as 4 years or more before clinical diagnosis via standard care pathways.3,4

The test runs on a simple enzyme-linked immunosorbent assay (ELISA) platform, which is widely available in hospital laboratories around the world and is used in our CLIA laboratory in Kansas, US.

 

 

1. Lam S, et al. EarlyCDT—Lung: an immunobiomarker test as an aid to early detection of lung cancer. Cancer Prev Res 2011; 4(7); 1126–34.
2. Chapman CJ, et al. EarlyCDT®—Lung test: improved clinical utility through additional autoantibody assays. Tumour Biol. 2012;33(5):1319-26.
3. Zhong L, et al. Profiling tumour-associated antibodies for early detection of non-small cell lung cancer. J Thor Oncol 2006; 1:513-519.
4. Jett J, et al. Determination of the detection lead time for autoantibody biomarkers in early stage lung cancer using the UKCTOCS cohort. J Thor Oncol 2017; 12(11):S2170.

Billing and Ordering the Test outside the US

EarlyCDT—Lung is available on a self-pay basis outside the US. The cost of the test is low relative to many other tests, particularly because it is not a genetic predisposition test.

Patients with private insurance need to confirm coverage with their insurance provider. For information on the self-pay price for the test, please contact your test provider.

 Contact your local provider

The EarlyCDT—Lung is available to order in numerous countries worldwide. Contact one of our distributors in your geographic region or contact Oncimmune if your region is not yet listed.

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Billing and Ordering the Test in the US

EarlyCDT—Lung requires an order from the treating physician for their patients with indeterminate lung nodules.

EarlyCDT—Lung requires only a tiny sample of blood (0.4mL).

There are 3 convenient options for blood collection and submitting the order to Oncimmune:

Physician EMR:

The test can be ordered through a physician’s EMR for delivery to a local lab, who can send the blood specimen to Oncimmune through one of our national reference lab partners.

Traditional blood draw:

Except for the blood collection tube, all materials needed to order and ship the specimen to Oncimmune are provided in the specimen collection kit.

Finger stick:

If the physician’s office does not provide phlebotomy services, our quick and convenient finger stick collection kit will allow the patient to provide a blood sample in the physician’s office.

Our specimen collection kits contain the test requisition form to complete for the order, and the materials needed for safely handling, preparing and shipping the blood specimen directly to Oncimmune for testing.

 Order a Specimen Collection Kit Here

Oncimmune’s EarlyCDT—Lung test is $910.00.

We realize insurance can be complicated, and we can help.

Medicare: 

  • Qualified claims are typically covered at 100%, but may be subject to a copay, coinsurance, and/or unmet deductible. 

Insurance & Medicare Advantage Plans:

  • While Oncimmune is out-of-network with commercial insurance payers, we actively work with all payers to seek coverage of the test within your plan.
  • Does your insurance cover out-of-network laboratory tests?
    • require a pre-authorization, or a referral for out-of-network benefits?
    • require the authorization to be obtained before the test is ordered or before having your blood drawn?
  • The allowed charges specified on the insurance EOB could be subject to co-pays, co-insurance and/or unmet deductibles, and will be invoiced to you by Oncimmune.

Self-Pay:  

  • Self-Pay is available for uninsured or out-of-network patients. Contact Client Services for self-pay pricing.
  • Oncimmune will not submit a claim to your health insurance.
  • Patients opting for Self-Pay must do so prior to Oncimmune performing the test.

To support your financial situation, Oncimmune’s Financial Assistance Plan offers payment options for patients with out-of-pocket responsibility, and discounts for patients who qualify, including patients with Medicaid.

For more information, please call Oncimmune Client Services at 888-583-9030, or email ClientServices@oncimmune.com

 Oncimmune’s Financial Assistance Plan

EarlyCDT—Lung Test Kit

The EarlyCDT—Lung Kit is affordable and easy to use. Professional laboratories can run the test on standard ELISA 96-well Microplate instruments.

The test is CE marked and meets the strict EU standards of manufacturing and quality control, as outlined in the In Vitro Diagnostics Medical Devices Directive 98/79/EC.

The EarlyCDT—Lung Kit is available worldwide outside of the US, subject to local regulations, and is distributed in numerous countries. Contact one of our distributors in your geographic region or contact Oncimmune if your region is not yet listed.

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