Nodify Lung® Nodule Risk Assessment
Tests for Diagnosis - Lung Nodule Management
Our blood-based tests for patients with a pulmonary nodule, Nodify Lung® Nodule Risk Assessment, assists physicians in reclassifying a patient’s risk of lung cancer by incorporating their protein biomarker results with radiographic imaging and clinical characteristics. Nodify Lung testing consists of the Nodify CDT® and Nodify XL2® proteomic tests, which can be ordered separately or together from a single blood draw to help reclassify risk of cancer to aid physicians in stratifying patients into distinct nodule management pathways with the goal of earlier diagnosis of cancer and avoidance of unnecessary invasive procedures.
Nodify CDT® Test - Identifying Higher Cancer Risk
The Nodify CDT test is a blood-based proteomic test that helps identify patients who have a suspicious lung nodule that is likely malignant or at a higher risk of being cancerous. Results allow physicians to identify patients who may be better candidates for timely invasive diagnostic procedures such as bronchoscopy, transthoracic needle biopsy, or surgical resection, with the goal of diagnosing cancer earlier. The Nodify CDT test enhances lung nodule risk assessment to facilitate compliance with clinical treatment guidelines.
Eligibility and Mechanism of Action
The Nodify CDT test is validated for use in patients who are 40 years or older, have no history of cancer except non-melanomatous skin cancer, have nodules between 8 and 30mm, and pre-test risk of lung cancer of less than 65%. The test measures the levels of seven circulating autoantibodies (P53, NY-ESO-1, CAGE, GBU4-5, SOX2, HuD, and MAGE A4) associated with lung cancer, combined with an algorithm to report out three potential results: High Level, Moderate Level, or No Significant Levels of Antibodies Detected (NSLAD).
The seven autoantibodies have been shown to be elevated for all types of lung cancer, and from the earliest stage of the disease. Unlike the tumor antigens themselves, the autoantibody levels can be measured accurately through a blood sample, based upon the signal amplification generated by the immune response to cancer. This mechanism of action likely reflects very early events in a tumor’s evolution; as the immune system initiates a response to the cancer, it can also trigger an expansion of self-reactive antibodies that can be measured in circulation.
Turnaround Time and Clinical Validation
The Nodify CDT test has an established average turnaround time of one business day from receipt of the blood sample, providing physicians with timely results to guide diagnostic planning. The clinical data for the test has been published in a number of peer-reviewed publications and presentations, including a clinical validation study published in late 2024 that confirmed the previously published performance of the test.
Nodify XL2® Test - Identifying Lower Cancer Risk
The Nodify XL2 test is a blood-based proteomic test that helps identify patients who have a suspicious lung nodule that is likely benign or at a reduced risk of being cancerous. Results allow physicians to identify patients who may be better candidates for routine CT surveillance to monitor for growth or shrinkage of the nodule over time instead of an invasive diagnostic procedure.
Eligibility and Clinical Data
The Nodify XL2 test is used for patients who are 40 years or older, have no history of lung cancer or other recent cancer diagnoses, have nodules between 8 and 30mm, and have a pre-test risk of lung cancer of less than or equal to 50%. A body of clinical data has been published in peer-reviewed journals and presentations and recent data from the ORACLE clinical utility study was published demonstrating a 74% reduction in unnecessary invasive procedures with the use of the test.
Test Process and Results
The Nodify XL2 test integrates peptides with clinical and radiological characteristics that are combined by an algorithm to report out three potential results: Likely Benign, Reduced Risk, or Indeterminate. Specifically, the Nodify XL2 test measures the relative abundance of two peptides (LG3BP and C163A) in circulation in the patient’s blood. The native proteins from which the peptides are derived have been associated with an inflammatory response to lung cancer. The clinical factors are patient age and smoking status, and radiological factors are nodule size, location, and edge characteristics.
Combined Testing Protocol
If both tests are ordered for the patient and Nodify CDT returns a result of High or Moderate Level indicating an increased risk of malignancy, then the Nodify XL2 test is cancelled. If Nodify CDT returns a result of NSLAD, then the Nodify XL2 test is performed, and both test results are typically available within four to five business days.
