Blood-Based Test Shows Superior Early Lung Cancer Detection Compared to Standard CT Screening
核心洞察
The Mercy Halo (搜索) blood-based lung screening test detected 31% of lung cancers one year before diagnosis, significantly outperforming the 8% detection rate of low-dose CT screening with Lung-RADS interpretation.
The investigational blood test identified 40% of cancers that were missed by standard low-dose CT imaging when interpreted using current Lung-RADS framework guidelines.
Analysis of National Lung Screening Trial (搜索) data revealed that the blood-based assay achieved 34.4% sensitivity comparable to low-dose CT/Lung-RADS at 39.5%, with particular effectiveness across all lung cancer histologies.
Results from the National Lung Screening Trial (搜索) (NLST) have revealed that the Mercy Halo (搜索) blood-based lung screening test demonstrated significant improvement in detecting early-stage preclinical lung cancer, particularly among high-risk patients not currently participating in low-dose CT screening programs, according to Mercy BioAnalytics (搜索).
Superior Early Detection Performance
The blood-based test achieved a remarkable 31% detection rate of lung cancers one year before diagnosis, substantially outperforming the 8% detection rate observed with low-dose CT or Lung Imaging Reporting and Data System (Lung-RADS) interpretation cited in the American Lung Association (搜索)'s 2025 State of Lung Cancer report. This superiority was consistent across all lung cancer histologies.
The investigational test demonstrated particular strength in identifying cancers missed by standard imaging approaches. Specifically, the Mercy test identified 40% of cancers that were missed by low-dose CT when images were interpreted using Lung-RADS, the current standard-of-care interpretation framework.
Comparable Sensitivity with Enhanced Capabilities
The blood-based assay detected 34.4% of cancers in the study, achieving sensitivity comparable to low-dose CT/Lung-RADS at 39.5%. Additionally, the test score showed an average increase of 79% in detected cases across samples collected during two sequential rounds of annual screening.
"This study marks a significant step toward expanding lung cancer screening accessibility and effectiveness, potentially transforming early detection strategies for millions of Americans," said Dawn Mattoon, PhD, chief executive officer of Mercy BioAnalytics (搜索). "We are excited to continue development of this assay as we look to build on our exceptional ovarian cancer test portfolio with the addition of lung cancer indications."
Clinical Context and Unmet Need
According to the American Lung Association (搜索)'s 2025 State of Lung Cancer report, only 28.1% of lung cancer cases are diagnosed at an early stage, where the 5-year survival rate reaches 65%. In contrast, 43% of cases are diagnosed at late stages, where the 5-year survival rate drops to just 10%. The report emphasizes that annual screening could increase effectiveness in identifying earlier-stage cancers.
Study Methodology and Findings
The NLST, conducted from 2002 to 2009, included 53,454 patients randomly assigned to either low-dose CT (26,722 patients) or chest radiography (26,732 patients). Participants received three screenings: one at baseline (T0) and two subsequent annual follow-up examinations (T1 and T2). The trial compared the effectiveness of low-dose CT scans versus chest x-ray scans in screening high-risk patients for lung cancer.
Limitations of Current CT Screening
A systematic analysis conducted by the developers and presented at the American Thoracic Society revealed overestimation of low-dose CT sensitivity in original NLST reports. The study found that low-dose CT sensitivity decreased as the diagnostic window length increased, with baseline screen point sensitivities of 86.3%, 73.3%, 70.2%, and 58.3% at 12, 18, 24, and 36 months, respectively, compared to 78.8%, 64.5%, 58.9%, and 49.0% for cumulative incidence screen sensitivity.
Most concerning, the analysis revealed that most cancers diagnosed at T1 or T2 low-dose CT scans had negative results in prior years. T1 cancers showed 55% negativity with T0 scan results, while T2 cancers demonstrated 64% and 69% negativity rates at T1 and T0 scans, respectively.