https://openbiodx.com/ Open-access biomarker and diagnostics intelligence, AI-curated from leading journals and industry sources. Every summary links to the original study. en https://openbiodx.com/2026/04/01/novel-hla-a-32-202-allele-identified-by-ngs-and-nanopore-sequencing/ A new HLA allele, HLA-A*32:202, was characterised using both next-generation and Oxford Nanopore sequencing, differing from HLA-A*32:01:01:01 by two nucleotide substitutions in exons 1 and 2. This is a brief allele report with limited broader clinical impact. Wed, 01 Apr 2026 08:00:00 +0100 https://openbiodx.com/2026/04/01/novel-hla-a-32-202-allele-identified-by-ngs-and-nanopore-sequencing/ https://openbiodx.com/2026/04/01/ai-powered-urine-test-reduces-unnecessary-prostate-biopsies-by-up-to-23/ A multicentre study evaluated EGPS, an AI-based urine test using extracellular vesicle gene expression to detect clinically significant prostate cancer without digital rectal examination. Across training, internal, and external validation cohorts the model achieved AUCs of 0.811-0.838 with sensitivity above 95%, reducing unnecessary biopsies by 15-23%. The DRE-free, non-invasive approach could streamline screening in men with PSA 0-15 ng/mL. Wed, 01 Apr 2026 08:00:00 +0100 https://openbiodx.com/2026/04/01/ai-powered-urine-test-reduces-unnecessary-prostate-biopsies-by-up-to-23/ https://openbiodx.com/2026/03/25/nine-rna-binding-proteins-form-prognostic-model-for-breast-cancer-survival/ Researchers constructed a 9-gene RNA-binding protein scoring model from TCGA data that effectively predicted 3-, 5-, and 9-year survival in breast cancer. High-risk patients showed higher tumour mutational burden, reduced CD8+ T-cell infiltration, and lower immune checkpoint expression. RPL9 was identified as a tumour suppressor whose downregulation drives proliferation, suggesting it as a potential therapeutic target. Wed, 25 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/25/nine-rna-binding-proteins-form-prognostic-model-for-breast-cancer-survival/ https://openbiodx.com/2026/03/24/keratin-7-staining-reveals-disease-progression-markers-in-fatty-liver-disease-bi/ Quantitative analysis of K7-positive cell populations in 36 MASLD liver biopsies found that ductular reaction density increased significantly with fibrosis stage, while progenitor cells peaked at grade 3 necro-inflammatory activity. Intermediate hepatocytes were notably higher in MASH versus simple steatosis. The study suggests that K7 immunohistochemistry could refine MASLD diagnosis and improve patient stratification in clinical trials beyond routine histological scoring. Tue, 24 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/24/keratin-7-staining-reveals-disease-progression-markers-in-fatty-liver-disease-bi/ https://openbiodx.com/2026/03/24/ai-foundation-models-extract-quantitative-mri-biomarkers-for-knee-osteoarthritis/ A modular system using fine-tuned foundation segmentation models (SAM, SAM2, MedSAM) converts routine musculoskeletal MRI into standardised quantitative biomarkers. The system demonstrated high concordance with expert annotations and enabled a three-stage knee triage cascade that reduces verification workload while maintaining sensitivity, plus 48-month prediction models for knee replacement and incident osteoarthritis. The open-source, model-agnostic architecture validates a pathway from automated measurement to clinical decision support. Tue, 24 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/24/ai-foundation-models-extract-quantitative-mri-biomarkers-for-knee-osteoarthritis/ https://openbiodx.com/2026/03/24/donor-age-and-sex-shape-msc-secretome-signalling-a-framework-for-potency-testing/ This targeted synthesis proposes a quadrant framework (fetal/adult x female/male) for understanding how donor characteristics programme mesenchymal stromal cell secretomes. Each quadrant showed distinct signalling biases: fetal female MSCs favoured anti-inflammatory pathways, fetal male angiogenic, adult female anti-fibrotic, and adult male regenerative/osteogenic. The authors translate these patterns into fit-for-purpose potency and critical quality attribute panels for cell therapy manufacturing. Tue, 24 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/24/donor-age-and-sex-shape-msc-secretome-signalling-a-framework-for-potency-testing/ https://openbiodx.com/2026/03/24/proenkephalin-predicts-worsening-renal-function-in-sepsis-patients/ A patient-level meta-analysis evaluated proenkephalin A 119-159 (penKid) as a biomarker for predicting renal deterioration and prognosis in sepsis. Based on the title and publication in Critical Care, this work aggregates individual patient data to assess the clinical utility of penKid in guiding early intervention for sepsis-associated acute kidney injury. Tue, 24 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/24/proenkephalin-predicts-worsening-renal-function-in-sepsis-patients/ https://openbiodx.com/2026/03/24/occupational-alcohol-exposure-causes-false-positive-etg-immunoassay-results-via-/ A coachbuilder exposed to solvent mixtures repeatedly tested positive for ethyl glucuronide on urine immunoassays despite abstinence. LC-HRAM-Orbitrap-MS analysis revealed the samples were EtG-negative but contained methyl, propyl, butyl, and hexyl glucuronides from aliphatic alcohol exposure, explaining the immunoassay cross-reactivity. These homologues were also detected in hair samples. An important cautionary finding for toxicology laboratories relying on EtG immunoassay screening. Tue, 24 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/24/occupational-alcohol-exposure-causes-false-positive-etg-immunoassay-results-via-/ https://openbiodx.com/2026/03/24/genomic-analysis-maps-species-specific-polymyxin-heteroresistance-in-e-coli-and-/ Whole-genome sequencing of 416 E. coli and K. pneumoniae isolates revealed distinct mechanisms of polymyxin heteroresistance: animal-derived E. coli carried phoPQ-pmrAB mutations linked to historical agricultural polymyxin use, while clinical K. pneumoniae showed divergent insertion sequence patterns in mgrB and progressed to full resistance faster under polymyxin pressure. MALDI-TOF MS was used for species identification. The findings have implications for antimicrobial susceptibility testing protocols and stewardship strategies. Tue, 24 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/24/genomic-analysis-maps-species-specific-polymyxin-heteroresistance-in-e-coli-and-/ https://openbiodx.com/2026/03/24/liquid-biopsy-workflow-enables-single-cell-telomere-profiling-of-myeloma-ctcs-fr/ A proof-of-principle workflow using size-based filtration isolates morphologically intact circulating tumour cells from peripheral blood of multiple myeloma patients, achieving a limit of detection of approximately 1 tumour cell per 10 million white blood cells. Isolated cells retain nuclear integrity for downstream immunophenotyping and 3D telomere FISH, revealing distinct genomic instability signatures compared with normal lymphocytes. This non-invasive approach could complement bone marrow-based MRD monitoring by adding biological risk assessment beyond simple tumour burden enumeration. Tue, 24 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/24/liquid-biopsy-workflow-enables-single-cell-telomere-profiling-of-myeloma-ctcs-fr/ https://openbiodx.com/2026/03/24/crispr-cas12a-biosensor-detects-cardiac-mirna-133a-at-femtomolar-sensitivity/ An electrochemiluminescence biosensor combining DNA nanotweezers, catalytic hairpin assembly, and CRISPR/Cas12a achieved a detection limit of 0.12 fM for miRNA-133a, a potential biomarker for acute myocardial infarction. The DNA nanotweezer-mediated approach significantly reduced background leakage compared to conventional methods, yielding a high signal-to-background ratio. The platform demonstrates a novel strategy for ultrasensitive nucleic acid detection. Tue, 24 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/24/crispr-cas12a-biosensor-detects-cardiac-mirna-133a-at-femtomolar-sensitivity/ https://openbiodx.com/2026/03/24/rb-immunohistochemistry-detects-cdk4-6-inhibitor-resistance-missed-by-ngs-in-met/ In a cohort of 50 ER-positive metastatic breast cancers, Rb loss was detected by IHC in 20% of cases, but NGS identified pathogenic RB1 alterations in only 33% of those Rb-deficient tumours. All Rb-loss cases showed p16 positivity, and 40% had neuroendocrine features. The study demonstrates that Rb IHC paired with p16 offers a rapid, cost-effective screen for CDK4/6 inhibitor resistance that conventional sequencing may miss. Tue, 24 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/24/rb-immunohistochemistry-detects-cdk4-6-inhibitor-resistance-missed-by-ngs-in-met/ https://openbiodx.com/2026/03/24/explainable-ai-in-oncology-methods-to-open-the-black-box/ This review surveys explainable AI methodologies applied to oncology, covering LIME, SHAP, Grad-CAM, Integrated Gradients, and newer approaches like ProtoPNet and counterfactual explanations. While these tools improve interpretability of AI predictions from imaging, genomics, and pathology data, challenges remain around computational cost, explanation consistency, and regulatory compliance. The paper provides a practical overview for labs considering AI adoption. Tue, 24 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/24/explainable-ai-in-oncology-methods-to-open-the-black-box/ https://openbiodx.com/2026/03/24/phage-derived-binding-protein-enables-rapid-culture-free-detection-of-a-baumanni/ Researchers developed a diagnostic platform using a phage endolysin-derived cell wall-binding domain conjugated to magnetic beads for selective capture of Acinetobacter baumannii. The system achieved 72.5% recovery in buffer and 55.7% in clinical sputum within one hour, with no significant cross-reactivity against other pathogens. The platform targets the LysM peptidoglycan-binding domain and remained stable at 4 degrees C for one month, offering potential for culture-independent point-of-care diagnostics. Tue, 24 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/24/phage-derived-binding-protein-enables-rapid-culture-free-detection-of-a-baumanni/ https://openbiodx.com/2026/03/24/european-physicians-prioritise-rapid-fever-tests-for-immunocompromised-patients-/ A survey of 265 hospital doctors across 30 European countries identified febrile immunocompromised patients, fever without a focus, and young infants as top priorities for new rapid diagnostic test development. Notably, 92% would find even a generic bacterial vs. non-bacterial test useful, suggesting that relatively simple point-of-care tools could fill significant clinical gaps in fever workup. Tue, 24 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/24/european-physicians-prioritise-rapid-fever-tests-for-immunocompromised-patients-/ https://openbiodx.com/2026/03/24/same-day-hepatitis-c-test-and-treat-model-trialled-using-antibody-only-screening/ This multi-country trial in Armenia, Georgia, and Tanzania compares a standard simplified HCV test-and-treat pathway with an innovative same-day treatment model using shortened read-time of the OraQuick point-of-care antibody test. The study targets people who inject drugs and assesses feasibility, retention in care, cure rates, and cost-effectiveness. Results could inform further simplification of HCV diagnostic pathways in low- and middle-income countries. Tue, 24 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/24/same-day-hepatitis-c-test-and-treat-model-trialled-using-antibody-only-screening/ https://openbiodx.com/2026/03/24/pleural-fluid-biomarkers-show-promise-for-diagnosing-malignant-effusions-and-gui/ This review evaluates emerging pleural fluid biomarkers · including ctDNA, microRNAs, proteins, and metabolites · for distinguishing malignant from benign pleural effusions. NGS and liquid biopsy technologies now enable noninvasive detection of actionable mutations (EGFR, ALK, KRAS, PD-L1) directly from pleural samples. Multi-biomarker panels outperform cytology alone, though standardisation and validation remain necessary before routine clinical adoption. Tue, 24 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/24/pleural-fluid-biomarkers-show-promise-for-diagnosing-malignant-effusions-and-gui/ https://openbiodx.com/2026/03/23/ceftobiprole-susceptibility-testing-mic-strips-reliable-disk-diffusion-depends-o/ A study of 422 S. aureus clinical isolates compared MIC Test Strip and disk diffusion against broth microdilution for ceftobiprole susceptibility. MIC Test Strips achieved 98.8% categorical agreement with zero very major errors under EUCAST criteria. Disk diffusion performance varied by breakpoint system: 89.6% agreement under EUCAST (with 40% of MRSA falling in the Area of Technical Uncertainty) versus 94.1% under FDA breakpoints. Labs using EUCAST should confirm MRSA results in the ATU zone by BMD or MTS. Mon, 23 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/23/ceftobiprole-susceptibility-testing-mic-strips-reliable-disk-diffusion-depends-o/ https://openbiodx.com/2026/03/23/plasma-metabolomics-classifier-detects-glioma-via-seven-metabolite-liquid-biopsy/ Multi-omics profiling of 189 glioma tissue samples and 430 plasma samples identified aberrant alanine/aspartate/glutamate metabolism and TCA cycle signatures as universal features across glioma subtypes, detectable in plasma. A seven-metabolite liquid biopsy model achieved AUC of 0.964 for adult glioma and 0.925 for paediatric brain tumours in independent test sets, with higher sensitivity for glioma than pancreatic cancer, supporting tumour selectivity. A promising non-invasive diagnostic tool for a cancer type with limited liquid biopsy options. Mon, 23 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/23/plasma-metabolomics-classifier-detects-glioma-via-seven-metabolite-liquid-biopsy/ https://openbiodx.com/2026/03/23/crispr-magnetic-microbots-enable-liquid-biopsy-cancer-subtyping-via-extracellula/ A homogeneous electrochemical biosensor using CRISPR/Cas12a-loaded magnetic microbots achieved amplified detection and discrimination of tumour-derived extracellular vesicle subtypes. The spatial confinement of CRISPR on intracellularly gelated magnetic cells enhanced trans-cleavage efficiency and reduced background signal. The platform demonstrated accurate cancer subtyping in clinical samples, offering a potential non-invasive tool for disease screening and classification. Mon, 23 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/23/crispr-magnetic-microbots-enable-liquid-biopsy-cancer-subtyping-via-extracellula/ https://openbiodx.com/2026/03/23/manganese-powered-cas12a-enables-amplification-free-rna-detection-at-femtomolar-/ Researchers discovered that manganese ions enhance Cas12a trans-cleavage activity 60-fold for RNA targets, enabling direct, amplification-free RNA detection with femtomolar sensitivity. The mechanism is conserved across multiple Cas12a orthologues and can detect ultrashort transcripts as small as 7 nucleotides. Clinical validation on serum samples showed the platform quantitatively measured circulating miR-21 and distinguished lung cancer patients from healthy controls, matching reference clinical assays. Mon, 23 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/23/manganese-powered-cas12a-enables-amplification-free-rna-detection-at-femtomolar-/ https://openbiodx.com/2026/03/23/crispr-cas13a-assay-detects-salmonella-in-under-60-minutes-across-large-clinical/ A CRISPR/Cas13a-based assay combined with recombinase polymerase amplification detected Salmonella spp. with 87.5% sensitivity and 98.8% specificity in hospitalised diarrhoea patients, and showed over 98.7% concordance with culture across three prospective cohorts totalling over 2,000 subjects. The 60-minute turnaround and 100 fg/uL detection limit make it a practical rapid alternative to time-consuming broth enrichment culture. Mon, 23 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/23/crispr-cas13a-assay-detects-salmonella-in-under-60-minutes-across-large-clinical/ https://openbiodx.com/2026/03/23/one-pot-crispr-cas12a-assay-with-ultrashort-hda-detects-respiratory-pathogens-at/ A novel isothermal amplification method (ultrashort HDA) paired with CRISPR/Cas12a enables one-pot nucleic acid detection at 37 degrees in under one hour, with a limit of detection of 5 aM. Tested on 58 clinical specimens for influenza A and 24 for Staphylococcus infection, the assay achieved 100% sensitivity and specificity versus PCR. The extraction-free, low-complexity format has strong point-of-care potential. Mon, 23 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/23/one-pot-crispr-cas12a-assay-with-ultrashort-hda-detects-respiratory-pathogens-at/ https://openbiodx.com/2026/03/23/genetic-testing-reshapes-the-diagnostic-workup-for-childhood-nystagmus/ This review outlines a practical neuro-ophthalmic framework for evaluating children with nystagmus, emphasising how genetic testing now identifies molecular causes in a growing proportion of cases. Ancillary studies including electrophysiology, OCT, and neuroimaging remain essential for guiding and interpreting genetic results. Relevant for labs offering paediatric genetic panels but outside core diagnostics focus. Mon, 23 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/23/genetic-testing-reshapes-the-diagnostic-workup-for-childhood-nystagmus/ https://openbiodx.com/2026/03/23/50-gene-ngs-panel-achieves-15-diagnostic-yield-for-hereditary-breast-and-ovarian/ Analysis of 414 HBOC index cases from the Murcia region using a 50-gene NGS panel found pathogenic variants in 15% based on 20 NCCN-recommended actionable genes. BRCA genes accounted for 60% of findings versus 40% from non-BRCA genes. Reclassification of variants of uncertain significance reduced their number by 25%, underscoring the value of periodic VUS re-evaluation in clinical genetics laboratories. Mon, 23 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/23/50-gene-ngs-panel-achieves-15-diagnostic-yield-for-hereditary-breast-and-ovarian/ https://openbiodx.com/2026/03/23/melanomas-in-blue-nevi-lack-tert-promoter-mutations-and-carry-uniformly-low-tumo/ Molecular profiling of 11 melanomas arising in blue nevi revealed universal GNA11/GNAQ mutations, frequent BAP1 alterations, and notably absent TERT promoter mutations with a consistently low TMB of 1 mut/Mb. This distinguishes them from other melanoma subtypes including deep penetrating nevus-like melanomas. Despite this low mutational profile, 73% developed distant metastases, highlighting the need for accurate subtyping. Mon, 23 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/23/melanomas-in-blue-nevi-lack-tert-promoter-mutations-and-carry-uniformly-low-tumo/ https://openbiodx.com/2026/03/23/landscape-analysis-of-14-digital-pathology-platforms-offers-selection-guide-for-/ A structured market analysis identified 14 commercially available digital pathology platforms and compared them on deployment models, WSI format compatibility, third-party AI integration, and pricing. Key variation was found in external algorithm support and scanner compatibility. The authors distil six practical recommendations for pathology institutes navigating platform acquisition amid rising digitalisation pressure and workforce shortages. Mon, 23 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/23/landscape-analysis-of-14-digital-pathology-platforms-offers-selection-guide-for-/ https://openbiodx.com/2026/03/23/deep-learning-system-diagnoses-and-predicts-recurrence-of-jaw-tumours/ Researchers developed a multimodal AI system for odontogenic keratocyst that fuses histopathology slides with clinical parameters for diagnosis, plus an interpretable model for recurrence risk prediction. The system outperformed existing models in both tasks on collected datasets. Clinical relevance for diagnostics labs is limited to oral pathology, but the multimodal fusion approach is notable. Mon, 23 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/23/deep-learning-system-diagnoses-and-predicts-recurrence-of-jaw-tumours/ https://openbiodx.com/2026/03/23/ultra-sensitive-ctdna-assay-predicts-treatment-response-65-days-before-imaging-i/ Using the NeXT Personal tumour-informed liquid biopsy platform in a phase II trial of 24 metastatic esophagogastric cancer patients, researchers found that ctDNA dynamics strongly correlated with tumour size changes. Lack of early molecular response was associated with significantly worse overall and progression-free survival. Molecular progression preceded imaging-detected progression by a median of 65 days, suggesting ultra-sensitive ctDNA monitoring could meaningfully accelerate treatment decisions. Mon, 23 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/23/ultra-sensitive-ctdna-assay-predicts-treatment-response-65-days-before-imaging-i/ https://openbiodx.com/2026/03/22/mitochondrial-lipidomics-reveals-arachidonic-acid-deficiency-as-targetable-featu/ UHPLC-mass spectrometry-based mitochondrial lipidomic profiling of 93 schizophrenia patients revealed elevated oxidised lipids and arachidonic acid deficiency correlating with cognitive impairment severity. Six-week AA supplementation improved cognitive performance and restored mitochondrial lipid homeostasis. While primarily a psychiatric intervention study, the work demonstrates the diagnostic potential of mitochondrial lipid profiling for stratifying patients and monitoring treatment response. Sun, 22 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/22/mitochondrial-lipidomics-reveals-arachidonic-acid-deficiency-as-targetable-featu/ https://openbiodx.com/2026/03/21/pan-cancer-lymph-node-ai-achieves-100-sensitivity-with-built-in-uncertainty-safe/ UPATHLN, a pathology foundation model with uncertainty quantification, was validated on 26,229 lymph nodes from 14 primary tumour origins. The system achieved an AUC of 0.986 and, critically, its uncertainty module intercepted all false negatives for mandatory pathologist review, securing 100% conditional sensitivity even for seven unseen tumour types. This reduced the review burden on negative nodes by 73%. Sat, 21 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/21/pan-cancer-lymph-node-ai-achieves-100-sensitivity-with-built-in-uncertainty-safe/ https://openbiodx.com/2026/03/20/six-gene-ddpcr-panel-achieves-100-sensitivity-for-thyroid-cancer-detection-in-fn/ A multiplex ddPCR panel targeting BRAF V600E, TERT promoter mutations, PIK3CA, and RAS variants was validated on 210 thyroid FNA specimens, achieving 0.1% VAF limit of detection and identifying five low-abundance BRAF mutations missed by ARMS-PCR. Combined with cytology, the panel reached 100% sensitivity, 71% specificity, and 96% diagnostic accuracy, significantly outperforming cytology alone. A practical tool for reducing indeterminate thyroid nodule diagnoses and avoiding unnecessary surgery. Fri, 20 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/20/six-gene-ddpcr-panel-achieves-100-sensitivity-for-thyroid-cancer-detection-in-fn/ https://openbiodx.com/2026/03/20/global-interlaboratory-study-exposes-significant-variability-in-myositis-autoant/ Fifteen laboratories across four continents tested 24 quality-control sera for myositis-specific and myositis-associated autoantibodies using their routine protocols. While near-perfect concordance was seen for about half the samples, results for key specificities including anti-TIF1-gamma varied substantially even between labs using the same commercial assay. The findings demonstrate an urgent need for harmonisation in myositis antibody testing to prevent inconsistent clinical decision-making. Fri, 20 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/20/global-interlaboratory-study-exposes-significant-variability-in-myositis-autoant/ https://openbiodx.com/2026/03/20/nanopore-full-rrna-operon-sequencing-improves-fungal-identification-in-ocular-in/ Twenty fungal isolates from ocular infections were characterised using Oxford Nanopore full rRNA operon sequencing and compared with conventional morphology and MALDI-TOF MS. The NGSpeciesID bioinformatic pipeline achieved species-level identification for nearly all isolates, successfully resolving closely related Aspergillus taxa and reclassifying Curvularia isolates. Performance depends heavily on bioinformatic pipeline choice and reference database completeness, but the approach shows strong potential as a complement to MALDI-TOF for fungal diagnostics. Fri, 20 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/20/nanopore-full-rrna-operon-sequencing-improves-fungal-identification-in-ocular-in/ https://openbiodx.com/2026/03/20/lancet-microbe-review-maps-the-expanding-toolkit-for-isoniazid-resistant-tb-diag/ A scoping review of 238 studies catalogues the molecular diagnostics landscape for isoniazid-resistant tuberculosis, identifying 27 NAATs, 8 line probe assays, 5 DNA microarrays, and multiple NGS platforms developed since 2000. Most met WHO performance targets but remain too complex or costly for low-resource settings. The review highlights the critical gap between diagnostic capability and field-level accessibility for the most common form of drug-resistant TB. Fri, 20 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/20/lancet-microbe-review-maps-the-expanding-toolkit-for-isoniazid-resistant-tb-diag/ https://openbiodx.com/2026/03/20/ai-based-pathologic-response-assessment-in-lung-cancer-after-neoadjuvant-therapy/ This study evaluates an AI system for assessing pathologic response in locally advanced non-small cell lung cancer following neoadjuvant chemo-immunotherapy. No abstract was available; significance is scored conservatively based on the clinically relevant topic. Fri, 20 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/20/ai-based-pathologic-response-assessment-in-lung-cancer-after-neoadjuvant-therapy/ https://openbiodx.com/2026/03/20/discarded-malaria-rapid-tests-repurposed-for-arbovirus-surveillance-in-haiti/ Researchers extracted nucleic acids from discarded malaria rapid diagnostic test cassettes collected from febrile patients in Haiti (2021-2023) and detected DENV-3 in 68 samples from 2023, confirmed by NGS sequencing with high similarity to Caribbean strains. No alphavirus or Oropouche virus was detected. The approach demonstrates that discarded RDTs can serve as a practical surveillance tool for arbovirus detection in settings where conventional surveillance is disrupted. Fri, 20 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/20/discarded-malaria-rapid-tests-repurposed-for-arbovirus-surveillance-in-haiti/ https://openbiodx.com/2026/03/20/ctdna-misses-lung-and-surgical-bed-recurrences-after-pancreatic-cancer-resection/ In 50 patients with resected pancreatic ductal adenocarcinoma, ctDNA and imaging agreed in 78% of cases. However, 10 patients had radiologic recurrence with negative ctDNA · predominantly in the lungs (5 cases) and surgical bed (5 cases). Only 17% of lung metastases were detected by ctDNA, compared with 100% of liver, lymph node, peritoneal, and bone metastases. This highlights important site-specific blind spots that radiologists must account for when interpreting negative ctDNA results. Fri, 20 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/20/ctdna-misses-lung-and-surgical-bed-recurrences-after-pancreatic-cancer-resection/ https://openbiodx.com/2026/03/19/irregular-borders-in-fibroadenomas-are-common-and-should-not-be-confused-with-ph/ A review of 912 fibroadenoma specimens found irregular borders in 20.6% of cases, challenging the conventional teaching that fibroadenomas are always circumscribed. Prior biopsy procedures were the strongest predictor of irregularity (OR 3.69). Myxoid and cellular subtypes showed the highest rates. The finding is diagnostically important: an irregular border in a fibroepithelial lesion is not exclusive to phyllodes tumours, and pathologists should consider this in their differential diagnosis. Thu, 19 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/19/irregular-borders-in-fibroadenomas-are-common-and-should-not-be-confused-with-ph/ https://openbiodx.com/2026/03/19/comprehensive-review-of-metrological-traceability-tools-for-urine-albumin-standa/ This report analyses the current status of reference measurement system components for urine albumin, a critical biomarker for kidney disease and vascular damage. Despite 17 years of progress, nonstandardised measurement procedures persist in clinical laboratories. The authors provide recommendations for improving standardisation, including interchangeability of secondary certified reference materials and establishing medically suitable analytical performance specifications. Thu, 19 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/19/comprehensive-review-of-metrological-traceability-tools-for-urine-albumin-standa/ https://openbiodx.com/2026/03/19/crispr-based-lipid-lowering-redefines-laboratory-medicine-s-role-in-gene-editing/ This Clinical Chemistry piece examines how CRISPR-based interventions for permanent lipid lowering are reshaping the landscape of laboratory medicine. As gene editing therapies targeting lipid pathways move toward clinical reality, clinical laboratories will need to adapt monitoring strategies and develop new assays to support this therapeutic paradigm shift. Thu, 19 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/19/crispr-based-lipid-lowering-redefines-laboratory-medicine-s-role-in-gene-editing/ https://openbiodx.com/2026/03/19/nxtag-respiratory-pathogen-panel-v2-demonstrates-high-accuracy-across-five-us-cl/ A multicentre evaluation of the NxTAG RPPv2 high-throughput multiplex assay for 21 respiratory pathogens analysed 2,145 nasopharyngeal specimens across five US sites. The panel achieved 95%+ positive percent agreement for most viral targets, consistently high negative percent agreement (99.2%+), and 99.9% reproducibility. Valid results were obtained for 99.7% of specimens. Strong performance data supporting clinical deployment for comprehensive respiratory pathogen detection. Thu, 19 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/19/nxtag-respiratory-pathogen-panel-v2-demonstrates-high-accuracy-across-five-us-cl/ https://openbiodx.com/2026/03/19/lip-ms-molecular-fishing-identifies-therapeutic-targets-for-a-traditional-chines/ Researchers combined metabolomics with limited proteolysis-coupled mass spectrometry to identify the linoleic acid metabolic pathway as a key target of a traditional Chinese medicine formula (GJKBW) in rheumatoid arthritis. The approach identified specific protein targets (FADS2, PLA2G4A, PLA2G15) and active compounds validated by molecular dynamics. Primarily a pharmacology study with limited direct diagnostics relevance. Thu, 19 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/19/lip-ms-molecular-fishing-identifies-therapeutic-targets-for-a-traditional-chines/ https://openbiodx.com/2026/03/19/intraoperative-mri-volumetrics-predict-survival-in-lower-grade-glioma-especially/ A retrospective single-institution study of 90 lower-grade glioma patients found that greater extent of resection and smaller residual T2/FLAIR volumes on intraoperative MRI predict longer progression-free and overall survival, with FLAIR-based metrics independently predictive in IDH-mutant tumours. Additional resection prompted by iMRI occurred in 56% of cases but did not independently improve survival. Relevant for neuropathology labs performing IDH mutation testing as part of integrated molecular-radiological prognostication. Thu, 19 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/19/intraoperative-mri-volumetrics-predict-survival-in-lower-grade-glioma-especially/ https://openbiodx.com/2026/03/19/collaborative-framework-proposed-to-streamline-ldt-validation-across-us-hospital/ This perspective proposes a national voluntary repository where hospital laboratories share standardised analytical validation data for laboratory-developed tests, reducing redundant validation work. The model would allow labs to implement LDTs with minimal duplication while manufacturers could leverage shared data for expanded FDA clearances. If adopted, this could significantly accelerate test deployment and broaden access to molecular diagnostics near the point of care. Thu, 19 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/19/collaborative-framework-proposed-to-streamline-ldt-validation-across-us-hospital/ https://openbiodx.com/2026/03/19/crispr-based-point-of-care-tests-push-toward-practical-h-pylori-screening/ This review traces the evolution of point-of-care testing for Helicobacter pylori, focusing on CRISPR-Cas diagnostic systems and advances in substrate engineering and signal transduction. The authors outline design principles for next-generation platforms aligned with WHO ASSURED criteria, aiming to replace costly endoscopy and lab-based PCR with rapid, affordable alternatives for resource-limited settings. Thu, 19 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/19/crispr-based-point-of-care-tests-push-toward-practical-h-pylori-screening/ https://openbiodx.com/2026/03/19/rapid-diagnostics-and-opportunistic-infections-drive-mortality-in-advanced-hiv-c/ In a prospective cohort of 419 adults with advanced HIV across five Brazilian hospitals, 18.1% died within 90 days. Rapid diagnostic tests identified opportunistic infections in 45.6% of participants, with histoplasmosis and cryptococcal meningitis significantly increasing mortality risk. ART-naive status, anaemia, and elevated creatinine were strongly associated with death. The findings underscore the critical role of rapid point-of-care diagnostics for OI screening in resource-limited settings. Thu, 19 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/19/rapid-diagnostics-and-opportunistic-infections-drive-mortality-in-advanced-hiv-c/ https://openbiodx.com/2026/03/19/ai-model-predicts-druggable-mutation-probability-before-genomic-profiling-in-lun/ An XGBoost model trained on 3,470 lung cancer patients predicted the probability of finding druggable mutations before comprehensive genomic profiling, achieving an AUROC of 0.85. Key predictors included sex, smoking history, histology, and metastatic sites. Deployed as a web application and validated in an independent cohort of 1,307 patients, the tool could help prioritise which patients undergo CGP and improve access to targeted therapies. Thu, 19 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/19/ai-model-predicts-druggable-mutation-probability-before-genomic-profiling-in-lun/ https://openbiodx.com/2026/03/19/ai-and-molecular-biomarkers-converge-to-reshape-lung-cancer-diagnostics/ This review examines how molecular biomarkers (EGFR, ALK, ctDNA), multi-omics technologies, and AI-driven imaging analysis are being integrated into lung cancer diagnostics. Machine learning applied to low-dose CT, radiomics, and liquid biopsy are improving early detection and risk stratification. The authors note that data standardisation, clinical validation, and interpretability challenges must be resolved before widespread clinical implementation. Thu, 19 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/19/ai-and-molecular-biomarkers-converge-to-reshape-lung-cancer-diagnostics/ https://openbiodx.com/2026/03/19/tumour-informed-copy-number-analysis-detects-ctdna-down-to-0-2-tumour-fraction/ Researchers developed informCNA, a bioinformatics method that uses copy number aberration profiles from tumour or high-TF plasma samples to detect ctDNA in shallow whole-genome sequencing data at tumour fractions as low as 0.2% · far below the typical 3% threshold. In 177 serial samples from 18 ovarian cancer patients, the method showed high concordance with CA-125 and identified recurrence a median of 3.7 months earlier than the standard protein marker. Thu, 19 Mar 2026 08:00:00 +0100 https://openbiodx.com/2026/03/19/tumour-informed-copy-number-analysis-detects-ctdna-down-to-0-2-tumour-fraction/