The Journal of Liquid Biopsy最新文献

{"title":"Direct detection of rare circulating tumor cells in peripheral blood mononuclear cells by scRNA seq: Spike-in strategy based feasibility study","authors":"Shivam Kumar ,&nbsp;Divya Janjua ,&nbsp;Udit Joshi,&nbsp;Tanya Tripathi,&nbsp;Apoorva Chaudhary,&nbsp;Neha Tanwar,&nbsp;Anmol,&nbsp;Aastha Mittal,&nbsp;Alok Chandra Bharti","doi":"10.1016/j.jlb.2026.100457","DOIUrl":"10.1016/j.jlb.2026.100457","url":null,"abstract":"<div><h3>Background</h3><div>Circulating tumor cells (CTC) provide a minimally invasive window into metastatic disease but are difficult to detect and estimate due to their rarity and heterogeneity. Conventional enrichment-based approaches introduce selection bias and fail to capture diverse CTC populations. Single-cell RNA sequencing (scRNA seq) enables unbiased transcriptomic profiling of diverse cell types and rare population within complex samples like blood. Here, we evaluated feasibility of a computational spike-in framework to assess the sensitivity and specificity of scRNA seq based CTC detection in a peripheral blood background.</div></div><div><h3>Methods</h3><div>Three PBMC datasets comprising 20,871; 14,367; and 13,731 cells were created by merging Cell Ranger-derived raw matrices from 12 PBMC samples (4 per dataset). Cervical cancer (CaCx) dataset (SRR13927092) raw matrices were prepared similarly. CaCx cells were randomly selected and spiked at levels of 50, 25, 10, 5, and 2 cells into each dataset, with three replicates per level. Linear regression, limit of detection (LOD) and limit of quantification (LOQ) estimation, were performed.</div></div><div><h3>Results</h3><div>Unsupervised gene expression profiling revealed distinct clusters of CaCx cells in PBMCs background using k-means clustering. Clustering with k-mean value 7 resulted specific CaCx clusters. The average detection efficiency ranged from 66% to 93% for unsupervised clustering. Supervised clustering with specific epithelial markers improved identification, achieving 95%-100% detection accuracy. Linear regression showed a high coefficient of determination (R² = 0.9991). The estimated LOD was 1.0 cell, while LOQ was around 3.3 cells.</div></div><div><h3>Conclusion</h3><div>This study confirms that single-cell analysis pipelines are competent, can effectively and correctly detect rare epithelial tumor cells in PBMCs with high sensitivity and reproducibility, even at very low concentrations.</div></div>","PeriodicalId":101235,"journal":{"name":"The Journal of Liquid Biopsy","volume":"11 ","pages":"Article 100457"},"PeriodicalIF":0.0,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146173899","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Advancing clinical integration of circulating tumor cells: Outcomes of an international expert consensus","authors":"Massimo Cristofanilli ,&nbsp;M. Jose Serrano","doi":"10.1016/j.jlb.2025.100452","DOIUrl":"10.1016/j.jlb.2025.100452","url":null,"abstract":"","PeriodicalId":101235,"journal":{"name":"The Journal of Liquid Biopsy","volume":"11 ","pages":"Article 100452"},"PeriodicalIF":0.0,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147538723","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Tissue expression of miR-504-5p and miR-429 as diagnostic biomarkers for endometrial cancer and endometrial intraepithelial neoplasia: a pilot study","authors":"A. Manzi ,&nbsp;C. De Luca ,&nbsp;F. Conticelli ,&nbsp;B. Zizolfi ,&nbsp;M. Guida ,&nbsp;G. Troncone ,&nbsp;A. Di Spiezio Sardo ,&nbsp;M.C. De Angelis","doi":"10.1016/j.jlb.2025.100451","DOIUrl":"10.1016/j.jlb.2025.100451","url":null,"abstract":"<div><h3>Introduction</h3><div>Endometrial cancer (EC) is the sixth most frequent female malignancy worldwide. Atypical endometrial hyperplasia (AEH), also termed endometrial intraepithelial neoplasia (EIN), represents the recognized precursor lesion. While hysteroscopy with biopsy remains the diagnostic gold standard, the lack of non-invasive biomarkers for early detection and follow-up is a major clinical limitation. MicroRNAs (miRNAs), small non-coding RNAs regulating gene expression, have emerged as potential diagnostic and prognostic tools in gynecological oncology.</div></div><div><h3>Objective</h3><div>We aimed to determine the accuracy of the predictive value of a selected panel of miRNAs (miR-504-5p and miR-429) obtained on endometrial samples, in detecting EC and EIN, and to explore their role along the neoplastic continuum.</div></div><div><h3>Methods</h3><div>A prospective observational study was conducted at the University of Naples “Federico II.” Thirty-seven patients were enrolled: EC (n = 15), EIN (n = 15), and controls with normal endometrium (n = 7). All underwent hysteroscopy with grasp biopsy or “Visual D&amp;C.” Formalin-fixed paraffin-embedded samples were processed for RNA extraction, and miRNA expression was analyzed by RT-PCR (Taqman Advanced miRNA Assays).</div></div><div><h3>Results</h3><div>Both miRNAs were successfully amplified in most cases. In EC, miR-504-5p was detected in 93.3 % and miR-429 in 100 % of samples, with mean Ct values of 32.2 and 29.7, respectively. AEH showed intermediate expression (93.3 % and 86.7 % detection rates; mean Ct 28.3 and 29.8). Normal endometrium displayed the highest expression (100 % and 85.7 %; mean Ct 25.5 and 26.8). A progressive downregulation of both miRNAs from normal tissue to AEH and EC was observed.</div></div><div><h3>Conclusion</h3><div>Our preliminary findings suggest that reduced expression of miR-504-5p and miR-429 characterizes the transition from EIN to EC, supporting their potential role as tumor suppressors in this setting. This two-miRNA panel could complement histopathology in distinguishing precursor lesions from carcinoma, addressing a key diagnostic challenge. Larger studies, including minimally invasive liquid biopsy approaches, are warranted to validate their clinical utility.</div></div>","PeriodicalId":101235,"journal":{"name":"The Journal of Liquid Biopsy","volume":"11 ","pages":"Article 100451"},"PeriodicalIF":0.0,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145979156","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Crossing barriers with CSF-based sequencing for leptomeningeal disease in EGFR mutant NSCLC","authors":"Bhuvan Chugh ,&nbsp;Richa Dave ,&nbsp;Aarthi Ramesh ,&nbsp;Ganesh Khutale ,&nbsp;Kanchan Hariramani ,&nbsp;Saloni Andhari ,&nbsp;Alain D'Souza ,&nbsp;Sandhya Iyer ,&nbsp;Madhura Basavalingegowda ,&nbsp;Sumit Halder ,&nbsp;Hrishita Kothavade ,&nbsp;Aravindan Vasudevan ,&nbsp;Atul Bharde ,&nbsp;Jayant Khandare ,&nbsp;Gowhar Shafi","doi":"10.1016/j.jlb.2025.100332","DOIUrl":"10.1016/j.jlb.2025.100332","url":null,"abstract":"<div><div>This case report highlights the critical role of cerebrospinal fluid (CSF)-based sequencing in precision oncology for a 64-year-old female with metastatic <em>Epidermal growth factor receptor</em> (<em>EGFR</em>)-mutant non-small-cell lung cancer (NSCLC) with leptomeningeal metastases spread. Isolating cell-free DNA (cfDNA) and capturing true live single circulating tumor cells (sCTCs) from CSF fluid is extremely challenging due to rapid degradation of DNA and extremely low abundance of sCTCs. In progressive disease, we successfully extracted cfDNA and sCTCs in CSF that revealed actionable mutations such as <em>EGFR</em> Exon 19 deletion and <em>ERBB2</em> amplification. The findings guided personalization of precision therapy, including intrathecal trastuzumab combined with systemic treatments, leading to significant clinical improvement and effective control of leptomeningeal disease.</div><div>CSF profiling opens a new diagnostic avenue in identifying resistance mechanism, when blood analysis showed no actionable information. This case demonstrates the transformative potential of CSF-based liquid biopsies to uncover critical mutations, monitor disease progression, and optimize outcomes for central nervous system metastases. Sequential molecular profiling and CSF analysis were instrumental in effective therapeutic strategies for this complex clinical case.</div></div>","PeriodicalId":101235,"journal":{"name":"The Journal of Liquid Biopsy","volume":"10 ","pages":"Article 100332"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145325951","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Chemotherapy response monitoring with DNA methylation-based ctDNA tumor fraction: Evidence from a real-world cohort of patients with advanced common solid malignancies","authors":"Christian D. Rolfo ,&nbsp;Moh'd M. Khushman ,&nbsp;Alessandro Russo ,&nbsp;Roberto Borea ,&nbsp;Bernard Herrman ,&nbsp;Jing Wang ,&nbsp;Jiemin Liao ,&nbsp;Carin R. Espenschied ,&nbsp;Sean Gordon ,&nbsp;Katie Quinn ,&nbsp;Kimberly C. Banks ,&nbsp;Arielle J. Medford","doi":"10.1016/j.jlb.2025.100442","DOIUrl":"10.1016/j.jlb.2025.100442","url":null,"abstract":"<div><h3>Background/objectives</h3><div>Chemotherapy remains standard for many cancers, but challenges remain in evaluating clinical response to therapy. Epigenomic circulating tumor DNA (ctDNA) quantification is an emerging molecular approach to tumor response assessment. Here, we examine a tissue-free, methylation-based assay to demonstrate how changes in circulating tumor fraction (TF) associate with outcomes in a real-world advanced, pan-cancer cohort treated with chemotherapy.</div></div><div><h3>Methods</h3><div>This retrospective study evaluated patients with advanced solid tumors treated with chemotherapy and serial ctDNA testing, both pre- and post-therapy initiation. Serial samples were analyzed with an analytically validated next-generation sequencing (NGS) methylation-based ctDNA assay. The primary outcome measured was real-world time to next treatment (rwTTNT) as a surrogate for progression free survival. Secondary outcomes included real-world overall survival (rwOS) and lead time from TF increase to rwTTNT event.</div></div><div><h3>Results</h3><div>Among 278 eligible patients, decreasing TF was associated with improved rwTTNT (aHR 0.55 [95 % CI 0.39, 0.79] p = 0.001). Patients achieving a ≥98 % decrease at any timepoint had superior outcomes (rwTTNT aHR 0.40 [95 % CI 0.28, 0.56] p &lt; 0.005; rwOS aHR 0.54 [95 % CI 0.38, 0.79] p &lt; 0.005). Patients with continuous TF decrease had longer rwTTNT than those with initial decrease followed by increase (aHR 0.05 [CI 0.004–0.575] p = 0.016). Increasing TF was detected in 64 patients with a median lead time to rwTTNT of 2.27 months.</div></div><div><h3>Conclusions</h3><div>On-treatment changes in methylation-based TF in chemotherapy-treated patients are associated with long-term outcomes. CtDNA monitoring offers an opportunity to rapidly evaluate therapy efficacy, potentially improving clinical decision-making regarding benefit vs toxicity and long-term patient outcomes.</div></div>","PeriodicalId":101235,"journal":{"name":"The Journal of Liquid Biopsy","volume":"10 ","pages":"Article 100442"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145466248","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"General practitioners’ attitudes towards liquid biopsy as a diagnostic test for advanced lung cancer","authors":"Danyon Lo ,&nbsp;Jenny Wong ,&nbsp;Rawiri Keenan ,&nbsp;James Fingleton ,&nbsp;Annie N.M. Wong","doi":"10.1016/j.jlb.2025.100330","DOIUrl":"10.1016/j.jlb.2025.100330","url":null,"abstract":"<div><h3>Background</h3><div>In New Zealand (NZ), lung cancer disproportionately affects our indigenous Māori population, with both incidence and mortality being three times higher than NZ Europeans. Incidence of endothelial growth factor receptor (<em>EGFR</em>) mutated lung cancer is two to three times higher in Māori, Pacific and Asian people compared to NZ Europeans. Outcomes could potentially be improved if testing was augmented by biomarker testing of circulating tumour deoxyribonucleic acid (ctDNA) at the outset of diagnosis. Testing as a liquid biopsy could be more accessible, faster, and lower cost compared to tissue biopsy.</div><div>We aimed to evaluate NZ General Practitioners' (GPs’) attitudes towards liquid biopsy.</div></div><div><h3>Methods</h3><div>A survey was conducted of NZ GPs and was distributed through online channels between November 2023 to January 2024.</div></div><div><h3>Results</h3><div>Seventy GPs responded and challenges reported with the diagnostic process of lung cancer were: limited GP appointments, poor access to imaging, and limited access to secondary care. 53/58 (91 %) of GPs were unaware of liquid biopsy. 46/58 (79 %) were initially not comfortable with pre-test genetic counselling associated for this. Some GPs highlighted the potential of liquid biopsy to complement existing procedures particularly in rural areas although concerns were expressed regarding culturally appropriate pathways. Provided adequate training and funding for liquid biopsy, 42/58 (72 %) of GPs stated they would be comfortable requesting liquid biopsy and the associated counselling.</div></div><div><h3>Conclusion</h3><div>Most GPs were not familiar with liquid biopsy but 72 % supported these tests to be incorporated into current pathways. Liquid biopsy could potentially reduce diagnostic delays and inequities in lung cancer.</div></div>","PeriodicalId":101235,"journal":{"name":"The Journal of Liquid Biopsy","volume":"10 ","pages":"Article 100330"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145363134","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"ESR1 analysis of liquid biopsy in breast cancer, one-year routine experience of an Italian clinical referral center","authors":"Thais Maloberti ,&nbsp;Laura Poppi ,&nbsp;Giulia Ciccimara ,&nbsp;Sara Coluccelli ,&nbsp;Floriana Jessica Di Paola ,&nbsp;Giulia Calafato ,&nbsp;Viviana Sanza ,&nbsp;Elisa Gruppioni ,&nbsp;Annalisa Altimari ,&nbsp;Sara Quercia ,&nbsp;Alessandra Bernardi ,&nbsp;Claudio Zamagni ,&nbsp;Roberta Minari ,&nbsp;Antonio De Leo ,&nbsp;Giovanni Tallini ,&nbsp;Dario de Biase","doi":"10.1016/j.jlb.2025.100331","DOIUrl":"10.1016/j.jlb.2025.100331","url":null,"abstract":"<div><h3>Background</h3><div>Activating mutations in the <em>ESR1</em> gene are a known mechanism of secondary resistance to endocrine therapy in metastatic estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2−) breast cancers. Liquid biopsy has become a non-invasive tool for molecularly characterizing these neoplasms and allows for dynamic monitoring through the analysis of circulating tumor DNA (ctDNA).</div></div><div><h3>Methods</h3><div>We analyzed 161 plasma samples from patients with metastatic ER+/HER2− breast cancer who had previously undergone treatment with endocrine therapy and CDK4/6 inhibitors. <em>ESR1</em> mutation analysis was performed using two NGS panels: Oncomine™ Breast cfDNA Assay v2 (n = 102) and Oncomine™ Precision Assay GX (n = 59). The sensitivity threshold (Limit of Detection - LOD) for variant detection was set at ≤0.5 %.</div></div><div><h3>Results</h3><div>Twenty-one samples (12.4 %) did not meet the quality criteria for <em>ESR1</em> analysis. <em>ESR1</em> mutations were identified in 29.1 % (n = 41) of the remaining 141 cases. The most frequent <em>ESR1</em> variant was the p.Asp538Gly (53.7 %). Multiple <em>ESR1</em> mutations were observed in 29.3 % of mutated cases, and co-mutations were detected in 61 % of cases, mainly with <em>PIK3CA</em> (36.6 %) and <em>TP53</em> (12.2 %). The median variant allele frequency (VAF) of <em>ESR1</em> mutations was 1.46 %. No statistically significant difference in mutation frequency emerged between the two panels (p = 0.6993).</div></div><div><h3>Conclusions</h3><div><em>ESR1</em> mutations are detectable in approximately one-third of ER+/HER2− metastatic patients undergoing liquid biopsy. NGS platforms allow for sensitive and in-depth analysis, highlighting co-mutations of potential clinical and therapeutic relevance.</div></div>","PeriodicalId":101235,"journal":{"name":"The Journal of Liquid Biopsy","volume":"10 ","pages":"Article 100331"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145325950","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Corrigendum to “Chemotherapy response monitoring with DNA methylation-based ctDNA tumor fraction: Evidence from a real-world cohort of patients with advanced common solid malignancies” [J Liq Biopsy, 10 (2025), 100442]","authors":"Christian D. Rolfo ,&nbsp;Moh'd M. Khushman ,&nbsp;Alessandro Russo ,&nbsp;Roberto Borea ,&nbsp;Bernard Herrman ,&nbsp;Jing Wang ,&nbsp;Jiemin Liao ,&nbsp;Carin R. Espenschied ,&nbsp;Sean Gordon ,&nbsp;Katie Quinn ,&nbsp;Kimberly C. Banks ,&nbsp;Arielle J. Medford","doi":"10.1016/j.jlb.2025.100448","DOIUrl":"10.1016/j.jlb.2025.100448","url":null,"abstract":"","PeriodicalId":101235,"journal":{"name":"The Journal of Liquid Biopsy","volume":"10 ","pages":"Article 100448"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145799753","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Circulating tumor DNA as part of the routine work-up for patients with suspected advanced lung cancer","authors":"Emma Holjak ,&nbsp;Tia Brasoveanu ,&nbsp;Saurav Verma ,&nbsp;Saqib Khan ,&nbsp;Morgan Black ,&nbsp;Inderdeep Dhaliwal ,&nbsp;Michael Mitchell ,&nbsp;Rahul Nayak ,&nbsp;Mehdi Qiabi ,&nbsp;Richard Inculet ,&nbsp;Dalilah Fortin ,&nbsp;Richard Malthaner ,&nbsp;Matthew Cecchini ,&nbsp;Anna Lapuk ,&nbsp;Daniel Breadner","doi":"10.1016/j.jlb.2025.100443","DOIUrl":"10.1016/j.jlb.2025.100443","url":null,"abstract":"<div><div>Liquid biopsy (LB) is a useful tool in patients with advanced non-small cell lung cancer (aNSCLC) to detect actionable molecular alterations and thereby allow genotype-matched therapies. Currently, LB is recommended for individuals diagnosed with aNSCLC who have an insufficient tissue sample or difficult-to-reach tumour tissue. Despite the potential advantages of LB, its incorporation into the standard diagnostic work-up for all newly diagnosed patients with aNSCLC is lacking. Our study aimed to evaluate whether addition of plasma circulating tumor DNA (ctDNA) next generation sequencing (NGS) testing early in the diagnostic work-up for patients with aNSCLC can improve the time to molecular results and treatment initiation. This was a single-centre quality improvement initiative with two cohorts of patients. Patients in the ‘ctDNA cohort’ had plasma ctDNA testing in addition to the standard diagnostic work-up. The ‘reference cohort' was a parallel group of patients who had the standard work-up (no LB). Tissue biopsy and reflex tissue NGS testing were done in both cohorts. ctDNA testing shortened the time to molecular results in the ctDNA cohort compared to the reference cohort (median, 14 vs 35 days; p = 0.01), the time from first respirology/thoracic surgery consult to molecular results (median, 22 vs 48 days respectively; p = 0.01), and the time from medical oncology consultation to initiation of first-line treatment (median, 12 vs 22 days; p = 0.01). In conclusion, in a publicly funded and single-payer healthcare system, ctDNA testing as part of the standard work-up for patients with aNSCLC provides molecular results significantly faster than tissue-based testing and shortens the time to treatment initiation.</div></div>","PeriodicalId":101235,"journal":{"name":"The Journal of Liquid Biopsy","volume":"10 ","pages":"Article 100443"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145528295","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"BLOODPAC's collaborations with European Union liquid biopsy initiatives","authors":"Jennifer Dickey ,&nbsp;Elaine Katrivanos ,&nbsp;Lauren C. Leiman ,&nbsp;Abde M. Abukhdeir ,&nbsp;Antonella Cardone ,&nbsp;Banu Saritas-Yildirim ,&nbsp;Carlos Galamba ,&nbsp;Cheyenne Jankiewicz ,&nbsp;Christian Rolfo ,&nbsp;Deepshikha Bhandari ,&nbsp;Emily Finnegan ,&nbsp;Francesca Fenizia ,&nbsp;Haydar Celik ,&nbsp;Ingrid Mehlhorn ,&nbsp;Jillian Walker ,&nbsp;Jose Luis Costa ,&nbsp;Kathy Williams ,&nbsp;Mark Sewart ,&nbsp;Matias Olsen ,&nbsp;Michael Wierzba ,&nbsp;Veronica Gonzales","doi":"10.1016/j.jlb.2025.100321","DOIUrl":"10.1016/j.jlb.2025.100321","url":null,"abstract":"<div><div>The adoption of liquid biopsy into clinical practice has revolutionized the landscape of cancer diagnostics and treatment monitoring. In the U.S., the Blood Profiling Atlas in Cancer (BLOODPAC) has significantly supported the advancement of these technologies through consensus building [<span><span>1</span></span>]. In collaboration with the United States (US) Food and Drug Administration (FDA), BLOODPAC has developed minimum technical data elements (MTDEs) and analytical validation protocols to streamline the assay development and regulatory assessment of liquid biopsy-based technologies. Additionally, BLOODPAC has established a pre-competitive data sharing model to support clinical implementation.</div><div>The European Union faces regulatory and access challenges that hinder widespread adoption of liquid biopsy technologies. Complexities under the In Vitro Diagnostic Regulation (IVDR) and Clinical Trials Regulation (CTR) have introduced variability and delays across member states. While recognizing Europe's strengths in developing robust frameworks and high standards for advancing precision oncology, this paper explores how BLOODPAC's efforts—particularly in standardization, validation, and data sharing—could inform and complement EU initiatives. BLOODPAC's experience in developing fit-for-purpose validation frameworks and fostering regulatory-industry dialogue offers particularly relevant insights for addressing EU-specific challenges. This paper proposes opportunities for collaboration and guidance development that could enhance European access to liquid biopsy-based tests for precision medicine, ultimately improving patient access and outcomes for cancer care and management.</div></div>","PeriodicalId":101235,"journal":{"name":"The Journal of Liquid Biopsy","volume":"10 ","pages":"Article 100321"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145108654","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}