If you have been diagnosed with a lung nodule, you might be wondering if it is cancerous, and what happens next. You are not alone. Almost 50% of those who receive chest X-rays or CT scans are told they have a nodule. The good news is that about 95% of nodules turn out to be benign.1
Most nodules are not a significant health concern, but it is important to know your own individual risk. You deserve reassurance if the nodule is benign, and informed treatment if it is cancerous. Nodify Lung® testing is a noninvasive test that provides crucial information to clarify your risk and help you and your doctor decide your next steps.
How does Nodify Lung® testing work?
Nodify Lung nodule risk assessment testing requires only a simple blood draw and uses two tests, the Nodify CDTTM and Nodify XL2® tests, to identify the risk of lung cancer. The Nodify CDT test detects specialized proteins called antibodies, which are produced by the immune system to fight disease-causing invaders including cancer. The immune system customizes antibodies for specific invaders, and the Nodify CDT test takes advantage of this specialization by searching for the antibodies used against lung cancer. These unique targets give the Nodify CDT test excellent specificity; this means if a nodule is benign, this test is not likely to mislabel it as cancer, so positive test results are exceptionally trustworthy.
The second test, the Nodify XL2 test, uses a broader strategy, detecting circulating proteins that are not antibodies but are known to increase in correlation with lung cancer and inflammation. This strategy gives the Nodify XL2 test excellent sensitivity; this means if cancer is present, this test is not likely to mislabel it as benign, so “likely benign” test results are exceptionally trustworthy.
By combining both tests with evaluation of other risk factors, Nodify Lung testing provides an individualized assessment with highly confident results.
What is the process and how are results interpreted?
Your blood sample is first screened with the Nodify CDT test, which is optimized for both specificity and speed. These features support physicians making an early identification of malignant lung nodules. Results are sent to your medical team within one day, and based on the test results and a variety of other factors they can quickly respond to a positive Nodify CDT test to determine next steps in your treatment plan.
If the Nodify CDT test is negative, Nodify XL2 testing is performed to add assurance that the nodule is benign. This test is optimized for sensitivity and with a “likely benign” Nodify XL2 result, you and your medical team have more confidence that the lung nodule is not cancerous.
How do I know if I qualify for Nodify Lung testing?
Your medical team will determine if Nodify Lung testing is appropriate in your case. They will consider risk factors such as the nodule’s size, your age, and your medical history. A small percentage of patients with lung nodules have risk factors that suggest immediate follow-up with more invasive testing than Nodify Lung testing. Most patients, however, have low to moderate risk of cancer and face a difficult decision to begin treatment, perform invasive tests, or simply monitor progression. These patients are ideal candidates for Nodify Lung testing.
How much will Nodify Lung testing cost?
Medicare Part B
Patients who meet the criteria for Medicare Part B coverage will not be charged any out-of-pocket expenses. For patients who do not meet the coverage criteria, Biodesix works with the patient’s medical team to ensure all options are considered. An Advanced Beneficiary Notice might be necessary if Medicare is ultimately unable to provide coverage.
State Medicaid
Patients with State Medicaid will not be charged any out-of-pocket expenses.
Private Insurance
Biodesix will work with your insurance company directly, filing your claims, and processing any necessary appeals to ensure that you receive the full coverage allowed under your plan.
No Insurance or Concerns About Cost
If you have a financial responsibility over $50 or are concerned about meeting the cost of your testing, you may qualify for reduced or no financial responsibility through the Biodesix Assist™ Financial Support Program. You can apply any time before or after testing. Follow the links below for more information or to submit an application. Have the following information ready to help complete the application: adjusted gross income, number of dependents, and information about extenuating financial circumstances.
Simple Test, Important Results
With results from Nodify Lung testing combined with providers medical expertise, patients with lung nodules can move from troubling ambiguity to clarity. Cutting-edge molecular diagnostic tools combined with comprehensive risk-factor analysis help your medical team decide when treatment is necessary and avoid invasive procedures when it is not.
Speak with your doctor to determine if Nodify Lung testing can help inform your care.
- Vachani, A., Thompson, J.C., Gould, M.K. Pulmonary Nodules. Reference Module in Biomedical Sciences, Elsevier, 2021 https://doi.org/10.1016/B978-0-08-102723-3.00183-9. (https://www.sciencedirect.com/science/article/pii/B9780081027233001839)