2024 White paper on recent issues in bioanalysis: Impact of LDT in US and IVDR in EU; AI/ML for High Parameter Flow Cytometry; The rise of Olink Technology; CDx for AAV Gene Therapies; Integrative Bioanalysis by Multiple Platforms; Super Sensitive ADA/NAb LBA ( - Recommendations on Advanced Strategies for Biomarkers, IVD/CDx Assays (BAV), Cell Based Assays (CBA), and Ligand-Binding Assays (LBA) - Regulatory Agencies' Input on Biomarkers, IVD/CDx, and Biomarker Assay Validation).

The 18th Workshop on Recent Issues in Bioanalysis (18th WRIB) took place in San Antonio, TX, USA on May 6-10, 2024. Over 1100 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 18th WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week to allow an exhaustive and thorough coverage of all major issues in bioanalysis of biomarkers, immunogenicity, gene therapy, cell therapy and vaccines.

Therapeutic Effects of GDF6-Overexpressing Mesenchymal Stem Cells through Upregulation of the GDF15/SIRT1 Axis in Age-Related Hearing Loss.

Background: It has been reported the therapeutic effects of mesenchymal stem cells (MSCs) on hearing loss. This study explored the therapeutic effects of growth differentiation factor 6 (GDF6) overexpression-induced MSCs (MSCs-GDF6) on age-related hearing loss (ARHL) and its underlying mechanisms.

Methods: Reverse transcription-quantitative PCR and western blotting were used to evaluate gene expression.

ERK1/2 Inhibition Alleviates Diabetic Cardiomyopathy by Suppressing Fatty Acid Metabolism.

Background: Diabetes mellitus is associated with morphological and functional impairment of the heart primarily due to lipid toxicity caused by increased fatty acid metabolism. Extracellular signal-regulated protein kinases 1 and 2 (ERK1/2) have been implicated in the metabolism of fatty acids in the liver and skeletal muscles. However, their role in the heart in diabetes remains unclear.

tiRNA-Gln-CTG is Involved in the Regulation of Trophoblast Cell Function in Pre-eclampsia and Serves as a Potent Biomarker.

Background: Pre-eclampsia (PE) is a gestational disorder that significantly endangers maternal and fetal health. Transfer ribonucleic acid (tRNA)-derived small RNAs (tsRNAs) are important in the progression and diagnosis of various diseases. However, their role in the development of PE is unclear.

Asperhydrindane A, a new hydrindane derivate isolated from a mangrove-derived fungi GXIMD 03158.

A new hydrindane derivative, asperhydrindane A (), along with two known sterol analogues [isocyathisterol () and ganodermasides D ()] were isolated from the mangrove-derived fungus GXIMD 03158 attaching to the mangrove L. The structure of was elucidated based on extensive spectral analysis, HRESIMS, and calculated ECD methods. All compounds were evaluated for antibacterial activity.

Retrospective Analysis of the Correlation between Umbilical Blood Flow Index and Maternal and Fetal Outcomes in Pregnant Women with Gestational Diabetes.

Gestational diabetes mellitus (GDM) is a common complication during pregnancy. This retrospective study investigates the correlation between umbilical blood flow index and maternal-fetal outcomes in pregnant women with GDM, aiming to contribute to evidence-based risk assessment and management strategy in this high-risk obstetric population. This retrospective study recruited 119 pregnant women with GDM who were admitted to the Yichang Central People's Hospital, between January 2022 and January 2024.

Application of the Omaha System-Based Continuous Care Model in Diabetes Health Management for Outpatients within the Framework of "Internet +".

Diabetes is a chronic lifelong condition that requires consistent self-care and daily lifestyle adjustments. Effective disease management involves regular blood glucose monitoring and ongoing nursing support. Inadequate education and poor self-management are key factors contributing to increased mortality among diabetic individuals.

Application of Cardiac Rehabilitation Aerobic Exercise in Patients with Stable Angina in Coronary Heart Disease.

A novel exercise protocol for cardiac rehabilitation aerobic (CRA) has been developed by Hebei Sport University, demonstrating efficacy in patients with coronary heart disease (CHD). The objective of this study was to evaluate the impact of CRA on precise cardiac rehabilitation (CR) for CHD patients presenting with stable angina pectoris. The study cohort comprised patients with stable angina who were categorized into three groups: the CRA group (n = 35), the power bicycles (PB) group (n = 34), and the control group (n = 43).

The Application Value of an Artificial Intelligence-Driven Intestinal Image Recognition Model to Evaluate Intestinal Preparation before Colonoscopy.

Artificial intelligence (AI), with advantages such as automatic feature extraction and high data processing capacity and being unaffected by fatigue, can accurately analyze images obtained from colonoscopy, assess the quality of bowel preparation, and reduce the subjectivity of the operating physician, which may help to achieve standardization and normalization of colonoscopy. In this study, we aimed to explore the value of using an AI-driven intestinal image recognition model to evaluate intestinal preparation before colonoscopy. In this retrospective analysis, we analyzed the clinical data of 98 patients who underwent colonoscopy in Nantong First People's Hospital from May 2023 to October 2023.

Predictive Value of Ocular Fundus Hemorrhage for Severe Coronary Artery Disease Assessed via SYNTAX Score.

The relationship between retinal fundus hemorrhage and the severity of coronary artery lesions remains unclear. This study aimed to explore the incidence of fundus hemorrhage in patients at high risk of coronary heart disease (CHD) and to examine its correlation with the SYNTAX score, a tool used to assess the complexity of coronary artery disease. This retrospective study consecutively enrolled patients undergoing coronary angiography (CAG) at Beijing Anzhen Hospital Hospital from June 2019 to January 2020.

Comparison of Different Thromboprophylaxis Regimens in Elderly Patients Following Hip Arthroplasty.

Deep venous thrombosis (DVT) represents a significant postoperative complication after artificial femoral head replacement, with the incidence increasing proportionally with patient age. This study aimed to evaluate the effect of early postoperative use of intermittent pneumatic compression devices (IPC), followed by the combined use of low molecular weight heparin (LMWH) after 48 hours, for the prevention of postoperative lower limb DVT in elderly patients undergoing hip arthroplasty. The retrospective study included 100 elderly patients who underwent unilateral femoral head replacement.

Neural Correlates of Social Perception Deficit in Schizophrenia: An Event-related Potential Study.

Background: Deficits in emotion recognition have been shown to be closely related to social-cognitive functioning in schizophrenic. This study aimed to investigate the event-related potential (ERP) characteristics of social perception in schizophrenia patients and to explore the neural mechanisms underlying these abnormal cognitive processes related to social perception.

Methods: Participants included 33 schizophrenia patients and 35 healthy controls (HCs).

Telomere Length and Oxidative Damage in Children and Adolescents with Autism Spectrum Disorder: A Systematic Review and Meta-Analysis.

Background: Autism spectrum disorder (ASD) has been reported to confer an increased risk of natural premature death. Telomere erosion caused by oxidative stress is a common consequence in age-related diseases. However, whether telomere length (TL) and oxidative indicators are significantly changed in ASD patients compared with controls remains controversial.

Three-Plane Calcaneal Osteotomy With Joint Preservation vs Subtalar Arthrodesis to Treat Painful Calcaneal Fracture Malunions.

Background: Calcaneal fracture malunion (CFM) commonly occurs with multiple pathologic changes and progressive pain and difficulty walking. The purpose of this study was to propose a modified 3-plane joint-preserving osteotomy for the treatment of CFM with subtalar joint incongruence, and to compare its efficacy to subtalar arthrodesis.

Methods: A retrospective comparative analysis of the data of 56 patients with CFM admitted from January 2017 to December 2022 was performed.

Patterns of Treatment and Real-World Outcomes of Patients With Non-small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations Receiving Mobocertinib: The EXTRACT Study.

Background: Real-world data regarding patients with non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion (ex20ins) mutations receiving mobocertinib are limited. This study describes these patients' characteristics and outcomes.

Methods: A chart review was conducted across three countries (Canada, France, and Hong Kong), abstracting data from eligible patients (NCT05207423).

Isoferulic Acid Inhibits Proliferation and Migration of Pancreatic Cancer Cells, and Promotes the Apoptosis of Pancreatic Cancer Cells in a Mitochondria-Dependent Manner Through Inhibiting NF-κB Signalling Pathway.

Isoferulic acid (IA), a derivative of cinnamic acid, is derived from Danshen and exhibits anticancer properties by disrupting cancer cell activities. However, its role in pancreatic cancer, the "king of cancer", was unknown. In this study, pancreatic cancer cells were subjected to treatment with IA (6.

Two pathogen-inducible UDP-glycosyltransferases, UGT73C3 and UGT73C4, catalyze the glycosylation of pinoresinol to promote plant immunity in Arabidopsis.

UDP-glycosyltransferases (UGTs) constitute the largest glycosyltransferase family in the plant kingdom. They are responsible for transferring sugar moieties onto various small molecules to control many metabolic processes. However, their physiological significance in plants is largely unknown.

Clinical Performance of MAGLUMI Diagnostic Tests for the Automated Detection of Dengue Virus.

Aims: The screening and diagnosis of dengue virus infection play a crucial role in controlling the epidemic of dengue fever, highlighting the urgent need for a highly sensitive, simple, and rapid laboratory testing method. This study aims to assess the clinical performance of MAGLUMI Denv NS1 in detecting dengue virus NS1 antigen.

Methods: A retrospective study was conducted to assess the sensitivity and specificity of MAGLUMI Denv NS1 using residual samples.

Animal Models for Human-Pathogenic Coronavirus and Animal Coronavirus Research.

Coronavirus epidemics have posed a serious threat to both human and animal health. To combat emerging infectious diseases caused by coronaviruses, various animal infection models have been developed and applied in research, including non-human primate models, ferret models, hamster models, mouse models, and others. Moreover, new approaches have been utilized to develop animal models that are more susceptible to infection.

Review of Methods for Studying Viruses in the Environment and Organisms.

Recent decades have seen growing attention on viruses in the environment and their potential impacts as a result of global epidemics. Due to the diversity of viral species along with the complexity of environmental and host factors, virus extraction and detection methods have become key for the study of virus ecology. This review systematically summarises the methods for extracting and detecting pathogens from different environmental samples (e.

Conserved Nuclear Localization Signal in NS2 Protein of Bombyx Mori Bidensovirus: A Potential Invertebrate ssDNA Virus Trait.

Bombyx mori bidensovirus (BmBDV), a significant pathogen in the sericulture industry, holds a unique taxonomic position due to its distinct segmented single-stranded DNA (ssDNA) genome and the presence of a self-encoding DNA polymerase. However, the functions of viral non-structural proteins, such as NS2, remain unknown. This protein is hypothesized to play a role in viral replication and pathogenesis.

Dufulin Impacts Plant Defense Against Tomato Yellow Leaf Curl Virus Infecting Tomato.

(TYLCV) poses a significant threat to tomato production, leading to severe yield losses. The current control strategies primarily rely on the use of pesticides, which are often nonselective and costly. Therefore, there is an urgent need to identify more environmentally friendly alternatives.

Establishment of Recombinant Gene Rabies Virus SRV and Identification of Its Biological Characteristics.

Canids act as a crucial intermediary in the transmission of rabies and , serving as co-infection hosts and pathogen carriers for both rabies and hydatid disease (HD) transmitted from animals to humans. Therefore, an effective and efficient bivalent oral vaccine for preventing HD and rabies is urgently required to reduce economic losses in husbandry resulting from rabies and HD. In this study, a full-length plasmid (pcDNA4-NPM+G+EgM123+eGFP+L) carrying the gene and fluorescence reporter genes of eGFP and four auxiliary transfection plasmids of rabies virus SRV (pcDNA4-N, pcDNA4-P, pcDNA4-G, pcDNA-L) were established by reverse genetics approaches and co-transfected to BSR cells by electrotransfection.

Epidemiology and Ecology of Toscana Virus Infection and Its Global Risk Distribution.

Toscana virus (TOSV), a member of the genus transmitted by sandflies, is acknowledged for its capacity to cause neurological infections and is widely distributed across Mediterranean countries. The potential geographic distribution and risk to the human population remained obscure due to its neglected nature. We searched PubMed and Web of Science for articles published between 1 January 1971 and 30 June 2023 to extract data on TOSV detection in vectors, vertebrates and humans, clinical information of human patients, as well as the occurrence of two identified sandfly vectors for TOSV.