Mercy BioAnalytics to Present Data at ASCO Evaluating Clinical Performance of a Blood-Based Lung Cancer Early Detection Assay in Biospecimens from the National Lung Screening Trial

Accepted ASCO abstracts highlight Mercy's blood-based lung cancer screening and lung nodule triage programs using specimens from the NLST biorepository, which was established to support validation of early detection lung cancer biomarkers

WALTHAM, Mass., May 26, 2026 /PRNewswire/ -- Mercy BioAnalytics, Inc., a pioneer in blood-based early cancer detection, today announced that it will present two abstracts at the 2026 ASCO Annual Meeting highlighting results from studies using biospecimens from the National Lung Screening Trial (NLST) repository.

The NLST was an NCI-sponsored randomized controlled trial that demonstrated a significant mortality benefit associated with annual low-dose CT-based screening. NLST established a biospecimen repository for the purpose of enabling the validation of early detection lung cancer biomarkers that might augment or replace low-dose CT (LDCT).¹ To date, nearly 900 requests for NLST data or biospecimens have been approved.² To our knowledge, Mercy's ASCO presentation will be the first use of blood specimens from NLST subjects for preliminary validation of early detection lung cancer biomarkers. This work represents an important milestone in advancing blood-based approaches for lung cancer screening and lung nodule triage in elevated-risk subjects.

The first study reports results from a blinded evaluation of a novel blood-based lung cancer screening assay in elevated-risk subjects from the NLST. In this dataset, the blood-based screening assay showed similar sensitivity to low-dose CT across two annual screening encounters and detected lung cancers that were missed by low-dose CT, supporting further evaluation of the assay for lung cancer screening in the elevated-risk population.

The second study reports results from a blinded evaluation of a novel blood-based pulmonary nodule triage assay in elevated-risk subjects from the NLST. Six percent of LDCT-screened subjects in NLST were scored as 3 or 4A using the Lung-RADS framework. Despite a 4% prevalence of cancer in this population, immediate diagnostic workup is not recommended. Mercy's blood-based assay exhibited 43% sensitivity for the detection of lung cancer in these subjects, supporting further evaluation as a reflex approach for LDCT-detected pulmonary nodules.

"The results of the National Lung Screening Trial documenting a 20% decrease in lung cancer mortality with low-dose CT has led to practice changing recommendations with screening now recommended in high-risk groups.  Mercy's encouraging preliminary results are exactly why the NCI set up the NLST biospecimen repository: to enable validation of promising blood biomarkers.  A blood test like Mercy's could increase lung cancer screening uptake and make evaluation of pulmonary nodules more precise, potentially leading to more lives saved," said Dr. Christine Berg, M.D. the now retired NCI lead investigator on the NLST. "I am excited about these results.  I have the good fortune to serve on the Clinical Advisory Board at Mercy and observed the meticulous care with which this work was done."

These results support further evaluation which is now underway of Mercy's blood-based approaches to lung cancer screening and risk stratification of LDCT-detected pulmonary nodules.

Mercy is continuing to advance blood-based approaches designed to expand access to earlier detection and improve decision-making in lung cancer screening and follow-up.

Presentation details for the two accepted abstracts will be available through the ASCO Annual Meeting program and Mercy's communications channels as the meeting approaches.

About Mercy BioAnalytics

Mercy BioAnalytics, Inc. is on a mission to relieve suffering and save lives through the early detection of cancer. Early-stage cancer is difficult to detect, but when found, is more often amenable to curative therapy. Mercy's patented Mercy Halo™ liquid biopsy platform utilizes biomarker colocalization to interrogate highly abundant, blood-based extracellular vesicles and particles that carry unique cancer signatures from their parent cells. Mercy's initial focus is the early detection of ovarian and lung cancers.

About the NLST

The National Lung Screening Trial (NLST) was a large randomized controlled trial that compared low-dose helical computed tomography (CT) scans with standard chest X-rays for detecting lung cancer in individuals at elevated risk associated with tobacco use history. A total of 53,454 eligible participants, aged 55-74 years, were recruited between 2002 and 2004 and randomly assigned to receive three annual rounds of screening with either low-dose CT or chest X-ray. The trial found that low-dose CT screening reduced lung cancer mortality by 20% compared to screening by chest X-ray (New England Journal of Medicine, 2011). The NLST was conducted by the American College of Radiology Imaging Network and the National Lung Screening Study Group with funding from the National Cancer Institute of the National Institutes of Health (NIH). In 2015, another NIH-funded study was published (Annals of Internal Medicine) following re-interpretation of the LDCT images from NLST using the American College of Radiology's recently released Lung RADS v1.0 framework. Application of this framework improved LDCT specificity from 73% to 87%, but reduced sensitivity from 94% to 85%.

About ECOG-ACRIN

The ECOG-ACRIN Cancer Research Group is a membership-based scientific organization known for advancing precision medicine and biomarker research through its leadership of major national clinical trials that integrate innovative genomic approaches. Nearly 21,000 member researchers and advocates from approximately 1,400 academic medical centers and community hospitals worldwide collaborate across 40 scientific committees to design studies spanning the cancer care spectrum, from early detection to the management of advanced disease. The group was formed in 2012 through the merger of the former Eastern Cooperative Oncology Group and American College of Radiology Imaging Network. To learn more, visit www.ecog-acrin.org and follow us on X @EAonc, Facebook, LinkedIn, YouTube, and Instagram.

ECOG-ACRIN is supported by the National Cancer Institute of the National Institutes of Health under awards U10CA180820 and U10CA180794. The content of this study is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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SOURCE Mercy BioAnalytics