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Bioanalysis & Biomarkers · Industry updates

Follow sourced scientific, clinical, partnership, capacity, and financial developments. Factual summaries and business interpretations are presented separately.

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Labcorp

Labcorp poster evaluates orthogonal RNA and DNA integrity checks for CGT bioanalysis

Labcorp published a conference-poster summary on independent RNA and DNA integrity assessment in cell and gene therapy bioanalysis. It evaluates Agilent TapeStation microfluidic electrophoresis as an orthogonal quality-control tool alongside qPCR and RT-qPCR, which do not directly measure overall integrity. The public summary describes the evaluation's objective and rationale, without quantitative performance results or peer-reviewed publication metadata.

Bioanalysis / PubMed

Review explains statistical pitfalls in anti-drug antibody assay cut points

Based on the PubMed abstract, this review explains how sample selection, experimental balance, outlier handling, transformation, and statistical methods affect anti-drug antibody assay cut points. It addresses screening, confirmation, titers, drug tolerance, and reassessment using clinical baseline samples. This is a practical review of validation decisions, not a new clinical efficacy study.

Bioanalysis / PubMed

Review examines greener solvent systems for bioanalytical microextraction

Based on the PubMed abstract, a Bioanalysis review examines switchable-hydrophilicity solvents and bio-derived deep eutectic solvents for sample preparation. It discusses extraction performance, matrix effects, reproducibility, and environmental trade-offs, with future emphasis on miniaturization and automation. The review evaluates methodological opportunities rather than validating a specific assay for regulated clinical sample analysis.

Labcorp

Labcorp poster describes a direct format for neutralizing anti-drug antibody assays

Labcorp posted a CBF 2026 conference-poster summary describing a direct assay format for neutralizing anti-drug antibodies. The approach is intended to address limitations of competitive assays when drug–target affinity is weak or signals are unstable. The public summary presents the assay concept, rather than quantitative validation results or a peer-reviewed clinical study.

Labcorp

Labcorp poster describes a shared free-IgE assay for a head-to-head clinical study

Labcorp's CBF 2026 poster summary describes a unified serum free-IgE assay supporting comparison of two IgE-targeting drug candidates, including a marketed comparator. The team evaluated assay conditions that can disturb drug–IgE equilibrium and reports establishing a fit-for-purpose method. The public summary does not identify the therapies or provide numerical validation metrics; it is a conference report.

Wave Life Sciences

Wave outlines WVE-006 development plans and WVE-007 Phase 2a studies

Wave's quarterly update describes planning for a registrational WVE-006 RNA-editing study in AATD and ongoing WVE-007 siRNA Phase 2a work. The company also reports FDA support for its LC-MS assay in the planned WVE-006 program. Regulatory feedback and trial plans do not constitute marketing approval or comparative efficacy evidence.

BioAgilytix

BioAgilytix opens a 360biolabs laboratory in Sydney

BioAgilytix announced a new 360biolabs laboratory in Sydney's Macquarie Park district. The company describes support for time-sensitive clinical samples, PBMC isolation, flow cytometry, and sample storage. It says shared procedures and quality systems support assay transfer across its laboratory network. These are company-reported capabilities.

Nature

Mass-spectrometry-based proteomics: from single cells to clinical applications

This review surveys improvements in proteomics sample preparation, instrumentation, data acquisition, and analysis. It connects single-cell and spatial profiling with protein interactions, modifications, and biomarker discovery in body fluids. Clinical implementation is discussed as an opportunity with remaining challenges, rather than proof that every discovery assay is ready for diagnostic use.

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