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Biomedicines
Volume 14
Issue 7
10.3390/biomedicines14071423
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Article

Diagnostic Performance of the AptoDetect™-Lung Biomarker for Lung Cancer in a High-Risk Korean Population: A Multicenter Prospective Study

by
Da Som Jeon
1,2,
Chang Dong Yeo
3,
Chi Young Kim
4,
Jung Seop Eom
5,
Wonjun Ji
1,
Min Jee Kim
1,
Jung-Min Kim
6,
Seong Hoon Yoon
7,
June Hong Ahn
8,
Jun Hyeok Lim
9,
Chaeuk Chung
10,
Dong Won Park
11,
Seung Hyeun Lee
12,*,† and
Chang-Min Choi
1,13,*,†
1
Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Republic of Korea
2
Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri 11923, Republic of Korea
3
Division of Pulmonology, Department of Internal Medicine, Eunpyeong St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul 03312, Republic of Korea
4
Division of Pulmonology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 06273, Republic of Korea
5
Department of Internal Medicine, Pusan National University School of Medicine, Pusan National University Hospital, Busan 49241, Republic of Korea
6
Aptamer Sciences Inc., Seongnam 13487, Republic of Korea
7
Division of Pulmonology, Allergy, and Critical Care Medicine, Department of Internal Medicine, Pusan National University Yangsan Hospital, Pusan National University School of Medicine, Yangsan 50612, Republic of Korea
8
Division of Pulmonology and Allergy, Department of Internal Medicine, Yeungnam University Medical Center, Yeungnam University College of Medicine, Daegu 42415, Republic of Korea
9
Division of Pulmonology, Department of Internal Medicine, Inha University Hospital, Inha University School of Medicine, Incheon 22332, Republic of Korea
10
Division of Pulmonology, Department of Internal Medicine, Chungnam National University Hospital, Chungnam National University College of Medicine, Daejeon 35015, Republic of Korea
11
Division of Pulmonology and Allergy, Department of Internal Medicine, Shihwa Medical Center, Namchon Medical Foundation, Siheung 15034, Republic of Korea
12
Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Internal Medicine, Kyung Hee University Hospital, College of Medicine, Kyung Hee University, Seoul 02447, Republic of Korea
13
Division of Oncology, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Republic of Korea
 
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*
Authors to whom correspondence should be addressed.
†
These authors contributed equally to this work.
Biomedicines 2026, 14(7), 1423; https://doi.org/10.3390/biomedicines14071423 (registering DOI)
Submission received: 4 June 2026 / Revised: 21 June 2026 / Accepted: 22 June 2026 / Published: 23 June 2026
(This article belongs to the Special Issue Advances in Lung Cancer: From Bench to Bedside (2nd Edition))
Versions Notes

Abstract

Background/Objectives: Blood-based biomarkers may improve risk stratification of indeterminate pulmonary nodules detected on low-dose computed tomography (LDCT). We evaluated the diagnostic performance and independent predictive value of an aptamer-based blood assay, AptoDetect™-Lung, in a high-risk Korean screening population. Methods: This multicenter prospective cohort study enrolled adults with Lung Imaging Reporting and Data System (Lung-RADS) category 3 or 4 pulmonary nodules identified on LDCT across ten tertiary hospitals in South Korea between June 2023 and December 2024. Analyses focused on a predefined high-risk subgroup meeting Korean screening criteria (age 54–74 years and ≥30 pack-years of smoking). Baseline serum AptoDetect™-Lung scores were measured. Associations with lung cancer diagnosis were assessed using univariate and multivariable logistic regression, adjusting for clinical and radiologic variables. Diagnostic performance was evaluated using receiver operating characteristic analysis. Results: Among 1084 participants with histopathologic confirmation, 319 met high-risk criteria, of whom 260 (81.5%) were diagnosed with lung cancer. In this subgroup, the AptoDetect™-Lung score was independently associated with malignancy after adjustment (adjusted odds ratio of 1.14 per unit; 95% confidence interval of 1.02–1.27; p = 0.020). Discriminative performance was higher in the high-risk subgroup than in the overall cohort (area under the curve [AUC] of 0.639 vs. 0.570; p = 0.025). Performance was higher for squamous cell carcinoma and small-cell lung cancer than for adenocarcinoma. A multivariable model incorporating biomarker score, Lung-RADS category, age, and family history achieved an AUC of 0.710. Conclusions: An aptamer-based blood biomarker may provide modest adjunctive value for risk stratification in high-risk individuals.
Keywords: lung nodule; biomarker; lung cancer screening; aptamer lung nodule; biomarker; lung cancer screening; aptamer

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MDPI and ACS Style

Jeon, D.S.; Yeo, C.D.; Kim, C.Y.; Eom, J.S.; Ji, W.; Kim, M.J.; Kim, J.-M.; Yoon, S.H.; Ahn, J.H.; Lim, J.H.; et al. Diagnostic Performance of the AptoDetect™-Lung Biomarker for Lung Cancer in a High-Risk Korean Population: A Multicenter Prospective Study. Biomedicines 2026, 14, 1423. https://doi.org/10.3390/biomedicines14071423

AMA Style

Jeon DS, Yeo CD, Kim CY, Eom JS, Ji W, Kim MJ, Kim J-M, Yoon SH, Ahn JH, Lim JH, et al. Diagnostic Performance of the AptoDetect™-Lung Biomarker for Lung Cancer in a High-Risk Korean Population: A Multicenter Prospective Study. Biomedicines. 2026; 14(7):1423. https://doi.org/10.3390/biomedicines14071423

Chicago/Turabian Style

Jeon, Da Som, Chang Dong Yeo, Chi Young Kim, Jung Seop Eom, Wonjun Ji, Min Jee Kim, Jung-Min Kim, Seong Hoon Yoon, June Hong Ahn, Jun Hyeok Lim, and et al. 2026. "Diagnostic Performance of the AptoDetect™-Lung Biomarker for Lung Cancer in a High-Risk Korean Population: A Multicenter Prospective Study" Biomedicines 14, no. 7: 1423. https://doi.org/10.3390/biomedicines14071423

APA Style

Jeon, D. S., Yeo, C. D., Kim, C. Y., Eom, J. S., Ji, W., Kim, M. J., Kim, J.-M., Yoon, S. H., Ahn, J. H., Lim, J. H., Chung, C., Park, D. W., Lee, S. H., & Choi, C.-M. (2026). Diagnostic Performance of the AptoDetect™-Lung Biomarker for Lung Cancer in a High-Risk Korean Population: A Multicenter Prospective Study. Biomedicines, 14(7), 1423. https://doi.org/10.3390/biomedicines14071423

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