Oncimmune Holdings plc (LON:ONC), the leading global immunodiagnostics group, has noted that recently published data from two clinical studies using Oncimmune’s EarlyCDT® Lung blood test, which is marketed in the US by Biodesix Inc. as Nodify CDTTM, confirmed both previously published performance, and the utility of combining Nodify CDT and Nodify XL2® tests to enhance diagnostic performance. Furthermore, these studies were recently presented at the American College of Chest Physicians (CHEST) annual meeting 2020.
The first paper (‘Abstract #A1464/Poster #P1319: ‘Identification of Likely Malignant Indeterminate Pulmonary Nodules by Analysis of Autoantibodies Against Lung Cancer-Associated Antigens‘) assessed the performance of the EarlyCDT Lung blood test in PANOPTIC clinical trial samples to further validate the clinical utility of the test in patients with incidentally identified lung nodules when correlated with clinical outcomes (average 2 years follow-up). The reported specificity 93% (95% confidence interval (CI) 86-97%) and positive predictive value (PPV) 74% (CI 57-85%) correlates with previous publications of the EarlyCDT Lung blood test.
The second paper (‘Abstract #A1476/Poster #P1324: ‘Use of Two Blood-Based Biomarker Tests in Series to Reclassify Risk of Indeterminate Pulmonary Nodules’) evaluated the utility of combining Nodify CDT and Nodify XL2 tests in series. This combination strategy is aligned with the marketing strategy of both products by Biodesix in the US. 32% of the IPNs in the low-moderate risk category were reclassified into either the high-risk category by Nodify CDT or the very low risk category by Nodify XL2. Therefore, this testing strategy could have reclassified 3 malignant nodules into earlier biopsy, and 6 benign nodules that unfortunately underwent unnecessary invasive procedures. By shifting 32% of patients into risk groups with different guideline recommended diagnostic plans, the combined testing strategy would have reduced delays in diagnosis of malignant nodules and helped reduce unnecessary procedures on benign nodules.
Oncimmune’s EarlyCDT Lung blood test is marketed in the US under Biodesix’s Nodify Lung brand as Nodify CDT. The test will assist physicians to identify patients with lung nodules at high risk of lung cancer. This test partners with Biodesix’s existing Nodify XL2 test which is designed to help identify lung nodules with a very low risk of cancer. Both tests will be offered together as the Nodify LungTM Nodule Risk Assessment strategy, giving physicians the ability to order both tests from a single blood draw.
Biodesix has a direct US national sales force who sell direct into pulmonologists and corporately into national hospital systems.
Dr Adam M Hill, CEO of Oncimmune commented: “Whilst the EarlyCDT Lung blood test is underpinned by substantive evidence of its utility in IPN patients and reduction in unnecessary invasive procedures, I welcome this independent validation of the panel with the important PANOPTIC sample set, and confirmation of the utility of a combined rule-in and rule-out strategy in the US nodule clinic setting.”