Oncimmune Holdings plc (LON:ONC), the leading global immunodiagnostics group, has noted the initiation of a study by Biodesix Inc using Oncimmune’s EarlyCDT® Lung blood test, which is marketed in the US by Biodesix as Nodify CDTTM.
Biodesix have initiated the “ALTITUDE” clinical utility study designed to evaluate the performance of Nodify LungTM (Nodify XL2TM and Nodify CDT in combination) in a randomised controlled study. The study “A Multicenter, Randomized Controlled Trial, Prospectively Evaluating the Clinical Utility of the Nodify XL2 Proteomic Test in Incidentally Discovered Low to Moderate Risk Lung Nodules” seeks to further demonstrate the efficacy of the Nodify XL2 and Nodify CDT tests. A secondary focus of the study will be to further understand the economic impact of the tests in guiding treatment choices and the potential impact of our tests in reducing overall healthcare costs in the US.
The ALTITUDE study objectives are to evaluate how the addition of the Nodify Lung test result impacts the clinical decision making for patients with new, incidentally identified solid lung nodules assessed as low to moderate risk of lung cancer. A total of 2,000 patients are expected to be enrolled in the study.
The trial has an adaptive study design with a blinded standard of care arm and 2:1 randomisation for open-label results for Nodify XL2. The first patients will be enrolled before the end of 2020, with Phase 1 of the study including only Nodify XL2, expected to enrol 500 patients. Phase 2 of the adaptive study design will include an open-label arm for Nodify CDT, which is aligned with Biodesix’s commercial testing algorithm.
Oncimmune’s EarlyCDT Lung blood test is marketed in the US under Biodesix’s Nodify Lung brand as Nodify CDT. The Nodify CDT test assists physicians in identifying patients with lung nodules at high risk of lung cancer and is partnered with Biodesix’s existing Nodify XL2 test, which is designed to help identify lung nodules with a very low risk of cancer. Both tests are offered in combination as the Nodify Lung 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 Holdings commented: “Oncimmune is committed to producing further evidence that supports both adoption and reimbursement decisions in the markets where EarlyCDT Lung is available. Part of our agreement with Biodesix in June 2019 was to continue to deliver high quality evidence in the US market with EarlyCDT Lung. The ALTITUDE study will build upon the data presented last week at the American College of Chest Physicians from the PANOPTIC study, whilst adding to the substantial evidence base already underpinning the use of our product globally.”