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Diagnostics
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Novel Biomarkers for Clinical Diagnosis and Prognosis
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Novel Biomarkers for Clinical Diagnosis and Prognosis

A Special Issue of Diagnostics (ISSN 2075-4418) belonging to the section "Clinical Diagnosis and Prognosis".

Deadline for manuscript submissions: 31 January 2027 | Viewed by 3558

Editor

Dr. Ji Hyun Park

E-Mail Website
Guest Editor
College of Pharmacy, Duksung Women’s University, Seoul 01369, Republic of Korea
Interests: hemato-oncololgy; biomarkers; personalized medicine; molecular signatures; prognosis; predictive diagnosis; blood analysis
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Biomarkers are essential in diagnosing a disease or pathogenic process, monitoring patients, and providing a prognosis for patients. Any biological indicator that can be tested can be utilized as a biomarker, including DNA, RNA, proteins, metabolites, blood, urine, and so on. Other physiological and morphological biomarkers may also be measured or used for clinical or diagnostic imaging.

Biomarkers are of significant therapeutic value in early disease diagnosis, before clinical symptoms have fully manifested; they have the potential to prolong the lives of patients or enhance their quality of life.

This Special Issue investigates the advancing field of novel biomarkers in clinical diagnosis and prognosis, as well as their applications, which offer innovative approaches to patient care.

Dr. Ji Hyun Park
Guest Editor

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 250 words) can be sent to the Editorial Office for assessment.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-anonymized peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Diagnostics is an international peer-reviewed open access semimonthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2600 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • biomarkers
  • personalized medicine
  • molecular signatures
  • prognosis predictive diagnostics
  • prognostic diagnostics
  • genetic biomarkers
  • blood analysis
  • liquid biopsy
  • tumor marker

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Published Papers (3 papers)

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Research

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17 pages, 9525 KB  
Article
Is There a Tumor Proportion Score Threshold at Which Tumor-Cell PD-L1 Adds Prognostic Information Beyond the International Prognostic Index in Large B-Cell Lymphoma?
by Mehmet Mutlu Kidi, Suheda Atas Ipek, Sendag Yaslikaya, Mahmut Buyuksimsek, Mehmet Turker, Yasemin Aydinalp Camadan, Sedat Biter, Tolga Koseci, Tugba Toyran, Melek Ergin, Berksoy Sahin, Ismail Oguz Kara and Ertugrul Bayram
Diagnostics 2026, 16(18), 3036; https://doi.org/10.3390/diagnostics16183036 - 19 Sep 2026
Abstract
Background/Objectives: In diffuse large B-cell lymphoma (DLBCL), the prognostic value of programmed death-ligand 1 (PD-L1) depends on the immunohistochemical threshold applied. We asked whether tumor-cell PD-L1 adds prognostic information beyond the International Prognostic Index (IPI). Methods: Tumor-cell PD-L1, quantified by the 22C3 tumor [...] Read more.
Background/Objectives: In diffuse large B-cell lymphoma (DLBCL), the prognostic value of programmed death-ligand 1 (PD-L1) depends on the immunohistochemical threshold applied. We asked whether tumor-cell PD-L1 adds prognostic information beyond the International Prognostic Index (IPI). Methods: Tumor-cell PD-L1, quantified by the 22C3 tumor proportion score (TPS), was assessed retrospectively in 95 patients with large B-cell lymphoma (87 DLBCL-NOS) given frontline chemoimmunotherapy. TPS was analyzed at the prespecified ≥1% threshold, post hoc at ≥10%, ≥25%, ≥50% and ≥70%, continuously, and with restricted cubic splines. Results: PD-L1 positivity (TPS ≥ 1%) was present in 73 patients (77%). After a median follow-up of 89.8 months, PD-L1 was not independently associated with overall survival (OS; adjusted hazard ratio [HR], 0.73; 95% CI, 0.35–1.53) or progression-free survival (adjusted HR, 0.91; 95% CI, 0.44–1.86); no threshold survived correction for multiplicity. An unadjusted association with OS emerged at TPS ≥ 70% (HR, 2.02; 95% CI, 1.02–4.02), but these patients more often had an IPI ≥ 3 (72% versus 36%) and it was attenuated after adjustment (1.53; 0.74–3.18). No definition improved model fit or discrimination beyond the IPI; the null result held in DLBCL-NOS and R-CHOP subgroups. Conclusions: Tumor-cell PD-L1 did not add prognostic information beyond the IPI for overall survival. Full article
(This article belongs to the Special Issue Novel Biomarkers for Clinical Diagnosis and Prognosis)
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15 pages, 853 KB  
Article
Baseline Inflammatory Biomarkers and Disease Burden for Predicting Response to Stapokibart in CRSwNP
by Yuzhe Hao, Xiangning Cheng, Yuxuan Liu, Shazhou Li, Bingyue Huo, Ziyi Long, Qianxue Hu, Tianjian Xie, Lijun Du, Bo Liu, Xuan Jiao, Shan Chen, Tao Zhou, Liuqing Zhou, Yue Zhou and Jianjun Chen
Diagnostics 2026, 16(13), 2127; https://doi.org/10.3390/diagnostics16132127 - 7 Jul 2026
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Abstract
Background: Stapokibart is a novel biologic for chronic rhinosinusitis with nasal polyps (CRSwNP). We aimed to identify baseline biomarkers predicting early (4-week) and mid-term (16-week) responses to stapokibart in CRSwNP. Methods: A total of 57 patients were prospectively enrolled. Baseline clinical data [...] Read more.
Background: Stapokibart is a novel biologic for chronic rhinosinusitis with nasal polyps (CRSwNP). We aimed to identify baseline biomarkers predicting early (4-week) and mid-term (16-week) responses to stapokibart in CRSwNP. Methods: A total of 57 patients were prospectively enrolled. Baseline clinical data and complete blood count (CBC) parameters were collected, and derived inflammatory indices were calculated. Patients were classified as responders or non-responders at week 4 and 16 based on achieving either a ≥8.9-point reduction in SNOT-22 or a ≥1-point decrease in Nasal Polyp Score (NPS). Results: Stapokibart significantly improved SNOT-22, VAS, and NPS at both week 4 and week 16 (all p < 0.001). At week 4, 80.7% achieved an early response. Responders showed significantly higher baseline eosinophil count and eosinophil percentage and lower neutrophil-to-eosinophil ratio (N/E) (all p < 0.05). Univariate analysis identified N/E, comorbid asthma, eosinophil count, and aggregate index of systemic inflammation (AISI) as predictors of early response (all p < 0.05). Multivariate analysis identified N/E as an independent predictor (OR = 0.943, p = 0.011; AUC = 0.756). At week 16, 75.4% of patients achieved a mid-term response. Responders had significantly higher baseline SNOT-22 scores and NPS (p < 0.05). Multivariate analysis showed that baseline NPS and SNOT-22 scores were independently associated with mid-term response, and their combined model showed good predictive performance (AUC = 0.832, 95% CI: 0.716–0.948). Conclusions: Peripheral blood inflammatory biomarkers, particularly N/E, may predict early response to stapokibart in CRSwNP, whereas mid-term response appears more strongly associated with baseline disease severity. These findings support biomarker-driven stratification for individualized treatment strategies in CRSwNP. Full article
(This article belongs to the Special Issue Novel Biomarkers for Clinical Diagnosis and Prognosis)
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Review

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24 pages, 1409 KB  
Review
Predictive Biomarkers for Asymptomatic Adults: Opportunities, Risks, and Guidance for General Practice
by Christian J. Wiedermann, Giuliano Piccoliori, Adolf Engl and Doris Hager von Strobele-Prainsack
Diagnostics 2026, 16(2), 196; https://doi.org/10.3390/diagnostics16020196 - 8 Jan 2026
Cited by 4 | Viewed by 2045
Abstract
Biomarker-based prevention is rapidly expanding, driven by advances in molecular diagnostics, genetic profiling, and commercial direct-to-consumer (DTC) testing. General practitioners (GPs) increasingly encounter biomarker results of uncertain relevance, often introduced outside the guideline frameworks. This creates new challenges in interpretation, communication, and equitable [...] Read more.
Biomarker-based prevention is rapidly expanding, driven by advances in molecular diagnostics, genetic profiling, and commercial direct-to-consumer (DTC) testing. General practitioners (GPs) increasingly encounter biomarker results of uncertain relevance, often introduced outside the guideline frameworks. This creates new challenges in interpretation, communication, and equitable resource use in primary care. This narrative review synthesizes evidence from population-based studies, guideline frameworks, consensus statements, and communication research to evaluate the predictive value, limitations, and real-world implications of biomarkers in asymptomatic adults. Attention is given to polygenic risk scores, DTC genetic tests, neurodegenerative and cardiovascular biomarkers, and emerging multi-omics and aging markers. Several biomarkers, including high-sensitivity cardiac troponins, N-terminal pro–B-type natriuretic peptide, lipoprotein(a), coronary artery calcium scoring, and plasma p-tau species, showed robust predictive validity. However, many widely marketed biomarkers lack evidence of clinical utility, offer limited actionable benefits, or perform poorly in primary care populations. Unintended consequences, such as overdiagnosis, false positives, psychological distress, diagnostic cascades, and widening inequities, are well documented. Patients often misinterpret unvalidated biomarker results, whereas DTC testing amplifies demand without providing adequate counseling or follow-up. Only a minority of biomarkers currently meet the thresholds of analytical validity, clinical validity, and clinical utility required for preventive use in general practices. GPs play a critical role in contextualizing biomarker results, guiding shared decision-making, and mitigating potential harm. The responsible integration of biomarkers into preventive medicine requires clear communication, strong ethical safeguards, robust evidence, and system-level support for equitable, patient-centered care. Full article
(This article belongs to the Special Issue Novel Biomarkers for Clinical Diagnosis and Prognosis)
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