MSACL 2025 Abstract

Lighting the Path From Research to Practice: LeMbA-MS for Pathology-Based Proteomic Biomarker Panel

Idris Mohd Najib (1), Thomas Stoll (1), Leo Bolero (1), Alp Bekensir (2), Greg Ward (3), David Beale (4), Michelle M Hill (1)
(1) ProSeek Bio Pty Ltd, Brisbane, Australia, (2) ResTech Labs, Brisbane, Australia, (3) Sullivan Nicolaides Pathology, Brisbane, Australia, (4) Commonwealth Scientific and Industrial Research Organisation (CSIRO), Australia

Michelle Hill, PhD, BSc (Hon I), BA (Presenter) ProSeek Bio Pty Ltd

Presenter Bio: Michelle Hill, PhD is a biomedical scientist and entrepreneur specializing in clinical proteomics and glycoprotein biomarker translation. She is Founder and CEO of Proseek Bio, developing LC–MS-based clinical blood tests, starting with ovarian cancer presurgical triage. She has authored over 140 publications and is an inventor on multiple diagnostics patents. Michelle previously held research leadership roles, and served as Secretary General of the Human Proteome Organization (HUPO).

Relevant Financial Disclosures (within past 24 months, reported on Apr 20, 2026) No relevant financial relationship(s) to disclose. Conflict mitigation NOT REQUIRED.

INTRODUCTION
Liquid chromatography–mass spectrometry (LC-MS) is widely used in proteomic biomarker discovery but is often replaced by immunoassays during clinical translation. However, multiple reaction monitoring (MRM) on triple quadrupole (QQQ) MS can offer superior specificity and sensitivity in selected applications. Advantages include multiplexing without antibody cross-reactivity and avoiding the high cost and timelines of antibody development. Despite these benefits, clinical adoption of proteomic LC-MS is limited by sample complexity and labor-intensive workflows.

To address this, we developed a translational glycoprotein biomarker platform—Lectin Magnetic Bead Assay coupled with Mass Spectrometry (LeMBA-MS)—which enables single-step glycoform enrichment [1]. LeMBA-MS has shown success in cancer biomarker research using biobanked samples [2, 3].

OBJECTIVES
To support LeMBA-MS implementation in pathology laboratories, we aimed to reduce hands-on time (HoT) and turnaround time (TAT), while ensuring robustness in real-world sample conditions.

METHODS
We established in vitro diagnostic (IVD)-quality procedures for manufacturing lectin-magnetic beads, enabling simplified sample processing for clinical serum. Instructions for Use were developed for both manual and liquid handler workflows. Biomarker stability was assessed in fresh and frozen serum and plasma samples under various handling and shipping conditions.

RESULTS
Selected ovarian cancer biomarkers showed equivalence between fresh and frozen serum samples. IVD-grade LeMBA beads reduced HoT from 30 to 5 hours and TAT from 7 to 1 day without loss of assay performance. Stability studies demonstrated robustness under a range of pre-analytical conditions.

CONCLUSION
This study supports the feasibility of deploying LeMBA-MS multi-marker panels in pathology workflows, enabled by reagent manufacturing under a quality management system and performance validation in clinically relevant conditions.

REFERENCES
[1] Dutt et al. 2023 Methods Mol Biol. 2628:395-411.
[2] Dutt et al. 2023 Proteomics Clin Appl. 17(4):e2200114.
[3] Sheahan et al. 2025 Proteomes 13(2):23.