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.

Treatment of antebrachial deformities secondary to premature closure of the distal radial physis using circular external skeletal fixation and distraction osteogenesis in skeletally immature dogs.

Objective: To report clinical outcomes of skeletally immature dogs with antebrachial deformities secondary to premature closure of the distal radial physis (PCDRP) treated with angular corrections and distraction osteogenesis using circular external skeletal fixation (CESF).

Study Design: Retrospective multi-institutional case series.

Animals: A total of 12 client-owned dogs with premature distal radial physeal closure.

The Limited Utility of Hemoglobin A1c as a Predictor for Periprosthetic Joint Infection Following Total Joint Arthroplasty: A Continuous Variable Analysis.

Introduction: Patients who have poorly controlled diabetes mellitus are at increased risk of periprosthetic joint infection (PJI). Nevertheless, an optimal preoperative hemoglobin A1c (HbA1c) threshold has not been established. This study sought to identify preoperative HbA1c thresholds that were predictive of adverse outcomes for total hip (THA) and total knee arthroplasty (TKA) patients.

Complete Blood Cell Count-Based Ratios Identify Total Joint Arthroplasty Patients Likely to Benefit from Perioperative Dexamethasone.

Background: Complete blood cell count-based ratios (CBRs), including the neutrophil-lymphocyte ratio (NLR) and monocyte-lymphocyte ratio (MLR), are inflammatory markers associated with postoperative morbidity. Given the link between the surgical stress response and complications after total joint arthroplasty (TJA), this study aimed to evaluate whether higher preoperative CBR values predict greater postoperative benefits associated with dexamethasone utilization.

Methods: The Premier Healthcare Database was queried for adult patients who underwent primary, elective total hip or knee arthroplasty (THA or TKA).

Evaluation of the ASPYRE-Lung targeted variant panel: a rapid, low-input solution for non-small cell lung cancer biomarker testing and experience from three independent sites.

Background: Many patients with non-small cell lung cancer (NSCLC) lack access to highly effective approved targeted therapeutics due to multiple gaps in biomarker testing. Challenges in comprehensive molecular testing include complexities associated with the need to assess the presence of multiple variants, costs of running multiple sequential assays per sample, high assay quality control (QC) failure rates, clinical need for rapid turn-around time (TAT) to initiate therapy, and insufficient tissue samples. The ASPYRE-Lung NSCLC assay addresses gaps in multiplexed testing by simultaneously analyzing DNA and RNA, detecting 114 actionable genomic variants across 11 genes, consistent with current NSCLC treatment guidelines.