Blood-Based Screening Test
Blood-Based Screening Test May Increase Preclinical Lung Cancer Detection
The blood-based test detected 31% of lung cancers 1 year prior to in-trial diagnosis compared with 8% of cancers identified by low-dose CT or Lung-RADS. According to the American Lung Association’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 is 65%.
Results from the National Lung Screening Trial (NLST; NCT00047385) revealed that the Mercy Halo blood-based lung screening test displayed a significant improvement in the detection of early-stage preclinical lung cancer, especially among patients at an elevated risk who were not currently engaged in low-dose CT screening programs, according to a news release from the developer, Mercy BioAnalytics.
Specifically, compared to an 8% detection of lung cancers within 1 year prior to diagnosis with low-dose CT or the Lung Imaging Reporting and Data System (Lung-RADS) in the American Lung Association’s 2025 State of Lung Cancer report, the blood-based test detected 31% of lung cancers 1 year before in-trial diagnoses. Additionally, this superiority was observed across all lung cancer histologies.
Moreover, the Mercy test identified 40% of cancers missed by low-dose CT when images were interpreted using Lung-RADS, which is the current standard-of-care interpretation framework. Furthermore, the blood-based assay detected 34.4% of cancers in the study, which was comparable to the sensitivity observed with low-dose CT/Lung-RADS at 39.5%. Additionally, the investigational test score showed an average score increase of 79% in detected cases in samples collected across 2 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," Dawn Mattoon, PhD, chief executive officer of Mercy BioAnalytics, said in the news release. "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."
The NLST was conducted from 2002 to 2009 and included 53,454 patients randomly assigned to low-dose CT (n = 26,722) and chest radiography (26,732), respectively.
