12 Biomarker Labs for Clinical Trials in 2026

Biomarker testing has expanded well beyond the traditional blood-draw assay, and the vendors built around it now span protein and metabolite detection platforms, tissue-based molecular pathology, non-invasive breath and imaging biomarkers, and AI-driven analysis of pathology slides and scans. A biomarker lab provider might specialize in ultrasensitive protein detection, metabolomics, or a specific disease area like neurodegeneration or oncology, and a clinical biomarker testing service increasingly sits alongside — or directly enables — patient stratification and companion diagnostic work. For Sponsors and CROs evaluating a biomarker analysis CRO, the underlying technology platform and disease-area track record often matter more than company size.

The companies below, presented in no particular order, work across a range of biomarker modalities. Collectively, they cover ultrasensitive protein and metabolite assays, molecular and digital pathology, non-invasive breath testing, AI-driven imaging analytics, and preclinical CNS biomarker models.

Meso Scale Diagnostics

Meso Scale Diagnostics, known as MSD, develops and markets the MULTI-ARRAY platform, which combines patterned arrays with electrochemiluminescence detection to profile many biomarkers simultaneously from a single sample. Founded in 1995 and based in Rockville, Maryland, the company states its technology is used by pharmaceutical companies, government institutions, and clinical laboratories worldwide, and its V-PLEX immunoassay panels cover cytokines, chemokines, and Alzheimer's disease biomarkers in a validated format.

Quanterix

Quanterix develops the Simoa platform, a digital immunoassay technology the company states can quantify proteins at concentrations far below the detection limits of conventional assay methods. Founded in 2007 and based in Billerica, Massachusetts, the company operates a CLIA-certified Accelerator laboratory and states its technology has supported research published in more than 3,400 peer-reviewed journals across neurology, oncology, immunology, cardiology, and infectious disease.

Metabolon

Metabolon specializes in metabolomics, offering untargeted and targeted metabolite profiling, lipidomics, and biomarker discovery services built around its Precision Metabolomics platform. Founded in 2000 and based in Morrisville, North Carolina, the company states its data and translational science expertise support drug discovery and development from target identification through clinical trials, and it has added multiomics biomarker discovery capabilities to its Integrated Bioinformatics Platform.

C2N Diagnostics

C2N Diagnostics developed the PrecivityAD and PrecivityAD2 blood tests, which use high-resolution mass spectrometry to detect brain amyloid pathology associated with Alzheimer's disease. Founded in 2007 and based in St. Louis, Missouri, the company states its biomarker assays have been used in more than 150 Alzheimer's disease and related research studies worldwide, including treatment and prevention trials involving disease-modifying therapies, and it operates a CAP-accredited, CLIA-certified clinical laboratory.

Owlstone Medical

Owlstone Medical developed Breath Biopsy, a platform that analyzes volatile organic compounds in exhaled breath as non-invasive biomarkers for cancer, respiratory, liver, and infectious disease. Founded in 2004 and based in Cambridge, England, the company states its technology has been used in more than 100 research papers and deployed at over 100 sites worldwide, and it holds a research collaboration agreement with the FDA's Center for Devices and Radiological Health to develop methods for identifying individual chemicals in breath.

IXICO

IXICO operates as an imaging contract research organization specializing in neuroscience imaging and biomarker analytics, using its AI-driven IXI platform to measure imaging biomarkers in neurological diseases including Alzheimer's, Parkinson's, and Huntington's disease. Founded in 2004 and based in London, England, the company states it has supported hundreds of neurological clinical trials and analyzed hundreds of thousands of scans, and in 2026 it released the tenth version of its IXI platform alongside a licensing-based TechBio expansion strategy.

OracleBio

OracleBio provides quantitative digital pathology and image analysis services, using platforms including Indica Labs HALO and Visiopharm Oncotopix to quantify biomarker expression on a cell-by-cell basis in tissue samples. Based in Holytown, Scotland, the company has offered these services since 2011, working across immuno-oncology, NASH, and fibrosis research from early discovery through clinical trials for pharmaceutical and biotechnology R&D teams. OracleBio's work spans preclinical discovery services, GCP-compliant clinical image analysis, and translational biomarker studies.

Navigate BioPharma

Navigate BioPharma Services designs customized biomarker assays using a technology-agnostic mix of genomic, flow cytometry, digital pathology, and ligand-binding methods for clinical development and companion diagnostic applications. Based in Carlsbad, California, the company operates as an independently run subsidiary within the Novartis group, tracing its roots to the clinical trial testing business of Genoptix, and it has partnered with companies including RareCyte and BD to expand its spatial biology and flow cytometry capabilities.

Targos Molecular Pathology

Targos Molecular Pathology provides clinical biomarker services built around molecular pathology, immunohistochemistry, and digital pathology, supporting biopharma companies developing targeted and immune therapies alongside companion diagnostics. Founded in 1999 and based in Kassel, Germany, the company states it has analyzed more than 250 different biomarkers across over 600 global clinical trials, and Discovery Life Sciences acquired Targos in 2021.

SynapCell

SynapCell is a preclinical CNS-focused CRO that uses translational in vivo EEG to generate biomarkers predicting how drug candidates will perform in human trials for epilepsy, movement disorders, and other brain pathologies. Based in La Tronche, near Grenoble, France, the company states it has 20 years of experience in preclinical EEG and processes its rodent models through its proprietary Cue platform, working with pharmaceutical and biotech clients across Europe, North America, and Asia.

VIDA Diagnostics

VIDA Diagnostics provides AI-powered quantitative imaging biomarker analysis for respiratory and cardiovascular clinical trials, producing what the company states can be up to 15,000 individual metrics spanning more than 50 biomarkers from a single CT scan. Based in Coralville, Iowa, the company's software holds FDA clearance, CE marking, and regulatory approvals in Canada, Australia, and Japan, and it has served as the quantitative CT imaging provider for SPIROMICS, a large multi-site COPD research study.

Amprion

Amprion developed the SAAmplify-αSYN test, a seed amplification assay that detects misfolded alpha-synuclein protein in cerebrospinal fluid to aid diagnosis of Parkinson's disease, Lewy body dementia, and Alzheimer's disease with Lewy body variant. Founded in 2007 and based in San Diego, California, the company states its test received FDA Breakthrough Device Designation in 2019 and became commercially available in 2021, and it continues to develop additional biomarker panels for neurodegenerative disorders.

Explore the full Biomarker Labs landscape

The companies above represent a portion of a much larger field.

Diligent's platform includes over 400 Biomarker Labs, many with Vendor qualification data available on demand. Book a demo to explore Diligent's full vendor discovery database.

This article is intended as an informational overview of vendors operating in this space. Inclusion on this list does not constitute an endorsement, recommendation, or qualification by Diligent.