TEST:

EarlyCDT®-Lung

The ECLS intervention is the most cost-effective screening alternative, with the highest probability of being cost-effective, when compared to no screening or LDCT screening. This result may change with modifications of the parameters, suggesting that the three alternatives considered in the main analysis are potentially cost-effective.

This review provides the first synthesised evidence to help guide LCS program design to minimise psychosocial harm for participants. Study heterogeneity and high risk of bias suggests that more robust testing of the impact of program design on psychosocial outcomes in real-world settings is needed. Future research should focus on developing feasible methods of managing the psychosocial experiences of LCS which complement the implementation requirements of large-scale screening programs.

Circulating proteins showed promise in predicting incident lung cancer and outperformed a standard risk prediction model and the commercialized EarlyCDT-Lung.

"Freenome...announced...it has acquired Oncimmune Ltd...with a commercialized CE-IVD marked EarlyCDT Lung blood test, autoantibody platform and research and development pipeline of 7+ cancer detection signatures...The acquisition of Oncimmune Ltd provides Freenome with clinical and commercial resources to complement Freenome’s frontline screening efforts."

The iDx-lung study will evaluate biomarkers and build a prediction model for the early detection of lung cancer to improve current LDCT screening protocols. The team of academic and industrial partners have successfully completed the set-up phase of this large-scale translational study. Recruitment, sample collection and analysis is underway.

Stratified analysis indicated higher sensitivity (17%, 95% CI, 7.2-32.1) in subjects with blood drawn up to 1 year prior to diagnosis. In conclusion, our study does not support a role of the EarlyCDT-Lung test in identifying the high-risk subjects in ever-smokers for lung cancer screening in the EPIC and NSHDS cohorts.

All results were concentrated above Brazilian GDP per capita, indicating that this strategy was not cost-effective in Brazil. The screening with liquid biopsy would only become cost effective if the Brazilian lung cancer prevalence context was greater than 15%.

"Oncimmune Holdings PLC on Friday said that it has collaborated with Siemens Healthineers AG, a Frankfurt-based medical technology company, in order to improve malignancy risk assessment in lung cancer....The collaboration will bring together Oncimmune's EarlyCDT Lung blood test with Siemens Healthineers' AI-Rad Companion Chest CT, an AI-powered radiology assistant that supports radiologists by performing automatic post-processing, quantifying and interpreting data....The collaboration will access data from the Early Detection of Cancer of the Lung Scotland trial, the large randomised study into the utility of EarlyCDT Lung in asymptomatic screening."

Prospective cohort studies, in which EarlyCDT Lung is used among patients with identified pulmonary nodules, are required to support a future assessment of the clinical and economic value of this test. Studies should investigate the diagnostic accuracy and clinical impact of EarlyCDT Lung in combination with Brock and Herder risk assessments. A well-designed cost-effectiveness study is also required, integrating emerging relevant evidence with the recommendations in this report.

The EarlyCDT®-Lung test had low sensitivity in identifying lung cancer cases in the general population based on blood drawn at most three years prior to diagnosis. In contrast, the risk discriminative performance of a protein-based risk model was notably better than the EarlyCDT-Lung test, as well as in comparison with the well-established PLCOm2012 smoking history-based risk prediction model. The potential of circulating proteins to inform eligibility for lung cancer screening warrant further evaluation in large-scale studies.

Negative psychological effects in TPG and positive effects in TNG were short-lived and most differences were small.

"Oncimmune Holdings plc...notes the Regional Ministry of Health for Aragon, Spain has announced that the Company's Early CDT® Lung blood test is to be adopted by the Thoracic Surgery Unit of the University Hospital Miguel Servet, Zaragoza, for use on solitary pulmonary nodules. This approval follows the issuing of a favourable assessment and report by the Evaluation Committee of the Aragonese Health System having met the necessary criteria with regards to efficacy and safety."

"Conclusion The iDx-Lung academic and industrial partners have successfully completed the set-up phase of this large-scale translational study and patient recruitment and sample collection is underway. Impact statement Biomarkers will be evaluated as markers for early detection of lung cancer to improve current screening programs."

The rationale of screening for lung cancer is to find patients in an early and resectable stage. However, the EarlyCDT® Lung test performed best in elderly, late stage lung cancer patients with a heavy smoking history. Based on these results, the current study finds insufficient sensitivity of the EarlyCDT® Lung test to be used as part of inclusion criteria in a low-dose CT program for detection of lung cancer.

"Oncimmune Holdings plc...today announces that it has successfully agreed to acquire the intellectual property (IP) and distribution rights for the EarlyCDT® technology in the People's Republic of China (PRC) and Hong Kong (HK) from Genostics Company Limited (Genostics), allowing the Company to pursue the optimum route to market in this important territory...The Asia-specific lung panel has been used in a multi-centre study, previously announced on 10 May 2019, and which is now due to complete in China in H1 2021. Data from this study are intended to be used to support approval by the China National Medical Products Administration (NMPA) for the use of the Asia-specific lung cancer test in the PRC." "

Specificity was estimated at 88.9% (95% CI: 80.5-94.5%) in the baseline control group, and 91.1% (95% CI: 83.2-96.1%) among controls presenting CT-detected nodules. The test panel showed insufficient sensitivity for detecting lung cancer at an equally early stage as with low-dose computed tomography screening.

P=N/A;Recruiting --> Completed | Phase classification: P2 --> PN/A | Trial completion date: Jan 2018 --> Dec 2020 | Trial primary completion date: Jan 2018 --> Dec 2020

"Oncimmune Holdings plc...today announces that it has signed a commercial contract to supply its EarlyCDT Lung blood test to NHS Norfolk & Waveney Clinical Commissioning Group ('Norfolk & Waveney'). Additionally, the Company has also signed a commercial contract to supply EarlyCDT Lung blood test into the NHS Lung Health Check Programmes in Wessex and Yorkshire as part of the iDx-LUNG evaluation programme. Following in-depth due diligence by the NHS, the Company has also been notified that The National Institute for Health and Care Excellence (NICE) has selected the EarlyCDT Lung blood test for Diagnostics Assessment Guidance...Under this commercial contract, Norfolk & Waveney will be evaluating the use of the EarlyCDT Lung blood test in a clinical setting."

Three biomarker tests (Early CDT-Lung, Nodify XL2, Percepta) have undergone extensive validation and are available to the clinician. The authors discuss these tests, with their clinical applicability and limitations, current ongoing evaluation, and future directions for biomarkers in lugn cancer screening and detection.

The results here demonstrate that at £70 per test the EarlyCDT-Lung will have a positive impact on patient outcomes and coupled with CT surveillance is a cost-effective approach to the management of patients with IPNs. The conclusions drawn from this analysis are robust to realistic variation in the parameters used in the model.

There were non-significant differences in lung cancer and all-cause mortality after 2 years.ECLS compared EarlyCDT-Lung plus CT screening to standard clinical care (symptomatic presentation), and was not designed to assess the incremental contribution of the EarlyCDT-Lung test. The observation of a stage-shift towards earlier-stage lung cancer diagnosis merits further investigations to evaluate whether the EarlyCDT-Lung test adds anything to the emerging standard of LDCT.