Clinical study initiated by Biodesix to further support adoption of Oncimmune’s EarlyCDT® Lung in US market

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 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.”

Click to view all articles for the EPIC: ,
Or click to view the full company profile:
    Facebook
    Twitter
    LinkedIn

    More articles like this

    Fintel plc

    Fintel Plc appoint Phil Smith as Non-Executive Director

    Fintel plc (LON: FNTL), the leading provider of Fintech and support services to the UK retail financial services sector, has announced the appointment of Phil Smith as Independent Non-Executive Director with immediate effect. Following a robust process led

    Pendragon plc

    Pendragon underlying Profit before Tax of £18.7m, up 73.1%

    Pendragon plc (LON:PDG) has announced its interim management statement. This Interim Management Statement covers the period from 1 January 2022 to 31 March 2022.  Unless otherwise stated, figures quoted in this statement are for the three

    SpaceandPeople returns to profit

    SpaceandPeople plc (LON:SAL) secures, sells, and manages flexible space for brand experiences, short term promotions and retailing in high footfall venues for its customers, including in shopping centres and travel hubs. The Group has issued full

    SpaceandPeople back into profit and positive earnings per share

    SpaceandPeople plc (LON:SAL) the retail, promotional and brand experience specialist, has announced its final results for the year ended 31 December 2021.   Financial Highlights ·       Revenue of £4.0 million (2020: £2.8 million and 2019: £7.7 million) ·       Operating profit of

    tinyBuild plc

    tinyBuild acquihires development studio Demagic Games

    tinyBuild plc (LON:TBLD), a premium video games publisher and developer with global operations, has announced the acquihire of Demagic Games, a development studio with 23 staff[1] currently based in Ukraine and Russia. The Company has been working

    Vertu Motors Plc

    Vertu Motors share buyback programme update

    Vertu Motors plc (LON: VTU) has announced that on 07 April 2022, it purchased 201,999 ordinary shares of 10p each in the Company on the London Stock Exchange, pursuant to the share buyback programme that was announced on 2nd March 2022 as

    Oncimmune Holdings report two further ImmunoINSIGHTS contracts signed

    Oncimmune Holdings plc (LON:ONC), the leading global immunodiagnostics group, today announced the signing of two new ImmunoINSIGHTS commercial contracts. The first contract is with an US-based clinical-stage biopharmaceutical company which is developing first-in-class cellular immunotherapies for cancer

    Lookers Plc

    Lookers shares to trade in excess of 150p says Zeus

    Lookers plc (LON:LOOK) has announced FY21 results that show record underlying PBT of £90.7m, 5.3% above our forecast of £86.2m. The outlook is suitably cautious given current supply constraints and likely impact of inflation on future