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Diagnostics & Testing

IVD, biomarker assays, and diagnostic platforms for clinical and research use.

135 suppliers in this category · Page 1 of 6

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How to choose Diagnostics & Testing partners

IVD and diagnostic vendors supply assays, instruments, and central lab services for clinical trials and biomarker programs. Evaluate FDA or CE clearance status, intended use (IVD vs RUO vs LDT), analytical validation, companion diagnostic pairing, and central lab logistics. This directory connects enriched diagnostic supplier profiles with regulatory context and application keywords.

Procurement decision framework

IVD, LDT, and research-use-only boundaries

IVD products carry regulatory clearance for stated intended uses. Laboratory-developed tests follow CLIA/CAP frameworks in the US with different commercial rules. RUO kits are not for clinical diagnostic use—confirm labeling before embedding in patient selection for trials.

FDA and CE clearance evidence

Request 510(k), PMA, or CE IVDR documentation for commercial diagnostics. For trial-only use, sponsors may accept RUO with fit-for-purpose validation documented in the protocol statistical analysis plan.

Central lab vs kit vendor models

Central labs unify shipping, stability, and data transfer across global sites; kit vendors ship collection materials to sites with local processing. Hybrid models use kit vendors with central analysis for complex biomarkers.

Companion diagnostics and co-development

Companion diagnostics require aligned development with the therapeutic asset. Early engagement with diagnostic partners reduces risk of approval delays when CDx is mandatory for labeling.

Analytical validation and trial endpoints

Validate precision, accuracy, reference ranges, and stability in the matrix and population of your trial. Biomarker assays powering primary endpoints need pre-specified success criteria and central review blinding procedures.

Editor's picks

Curated enriched profiles worth citing—selected for structured certifications, product data, and primary-source evidence, not paid placement.

  • Parse:Single-cell genomics platform vendor with enriched product catalog—reference for biomarker and multiomics trial workflows.
  • Radiometer:Blood gas and acute care diagnostics instrumentation with verifiable regulatory context for hospital-adjacent trial sites.
  • EKF Diagnostics:Point-of-care and central lab diagnostic supplier with structured product and certification data.

All Diagnostics & Testing suppliers

AdipoGen Life Sciences

Life Science Reagents

AdipoGen Life Sciences is a private life science reagents manufacturer and global distributor specializing in innovative antibodies, proteins, ELISA kits, small molecules and diagnostic kits for inflammation, immune responses, cancer and metabolic disorders. With corporate headquarters in San Diego and operational headquarters in Switzerland, plus R&D and production labs in Epalinges, it serves academic and industrial R&D worldwide through a broad, niche portfolio and technical support.

AI-Driven Spatial Biomarkers

Diagnostics & Testing

Nucleai is a private precision medicine company focused on AI-driven spatial biomarkers and digital pathology, primarily in oncology and immunology. It partners with biopharma, diagnostics companies, and research institutions to apply multimodal AI and spatial biology for predictive biomarker discovery, patient stratification, and trial optimization. Its platform analyzes digital pathology slides and clinical data to produce actionable insights for drug development and diagnostic programs.

AI-Powered Antibiotic Resistance Diagnostics

CRO & Clinical Services

Informuta develops AI-powered diagnostics that forecast antibiotic resistance before it emerges. Founded in 2023 and headquartered in San Diego, the company uses whole-genome mutational signatures and biologically explainable AI to predict treatment-emergent resistance risk. Peer-reviewed validation in Nature Communications demonstrated 92-100% accuracy in Pseudomonas aeruginosa resistance forecasting.

ATCC

CRO & Clinical Services

ATCC (American Type Culture Collection) is a nonprofit global bioresource center and standards organization supplying authenticated cell lines, microorganisms, organoids, nucleic acids, and reference materials. It supports oncology, immunology, toxicology, molecular diagnostics, and bioproduction with advanced models, standards, and ‘omics-backed data to improve assay reliability and research reproducibility.

Agilent Technologies

Diagnostics & Testing

Agilent Technologies is a public laboratory technology company based in Santa Clara, California. It supplies instruments, software, consumables, and services for pharma, diagnostics, and life-science labs across chromatography, mass spectrometry, spectroscopy, sample prep, and related workflows.

AlphaLabs - AlphaLabs

CDMO & Manufacturing

Alpha Laboratories (AlphaLabs) is an Ontario-based diagnostics provider offering medical laboratory testing, diagnostic imaging, ECG and Holter monitoring, and specimen collection services, supported by patient and clinician portals. It also delivers raw material analysis, elemental analysis, and pharmaceutical product testing for manufacturers, operating state-of-the-art, accredited laboratories licensed by the Ontario Ministry of Health.

Ambry Genetics

Diagnostics & Testing

Ambry Genetics is a diagnostics company focused on hereditary cancer testing, rare-disease exome sequencing, and RNA-enhanced variant interpretation. It also offers the CARE Program for patient identification and testing workflow support, making it relevant to clinical diagnostics buyers and research teams.

Amprion

Diagnostics & Testing

Amprion is a private neurodiagnostics company built around its SAAmplify-αSYN CSF assay for detecting misfolded α-synuclein. It serves clinicians, researchers, and biopharma teams working on Parkinson’s disease, Lewy body dementia, and other synucleinopathies.

AnteoTech

Life Science Reagents

AnteoTech is an ASX-listed Australian diagnostics and advanced materials company headquartered in Brisbane. Its Life Sciences division provides patented AnteoBind™ metal-ion surface chemistry and bioconjugation solutions that enhance immunoassays and IVD performance, supported by ISO 9001:2015–certified quality systems.

Antibodies, Assays & Research Reagents for Drug Discovery

Life Science Reagents

Abcam is a Cambridge, UK–headquartered supplier of antibodies, proteins, assays, cell lines, lysates, and related reagents that support life science research, drug discovery, and diagnostic and therapeutic applications. Now part of Danaher, it serves global academic, biotech, and pharma customers with an extensive, validated catalog spanning oncology, neuroscience, infectious diseases, and metabolic disorders.

Antibodies, Proteins & Custom Reagents

Life Science Reagents

BioLegend is a San Diego–based developer and manufacturer of antibodies, recombinant proteins, kits, proteogenomics tools and custom reagents for biomedical and clinical research. It supports immunology, oncology, neuroscience, stem cell and proteogenomics workflows with ISO 13485:2016–compliant products, IVD and ASR reagents, and extensive technical resources, serving global pharma and biotech R&D teams.

Aptamer Group

Life Science Reagents

Aptamer Group is a York, UK‑based public biotech company specialising in custom aptamer and Optimer® binder solutions for research, diagnostics, therapeutics and bioprocessing. Using its Optimer affinity platform, it delivers next‑generation synthetic binders that address limitations of antibodies, enabling high-specificity, stable reagents tailored to demanding life science applications.

Arima Genomics

Diagnostics & Testing

Arima Genomics is a private cancer diagnostics company that uses Hi-C–based 3D genome sequencing to integrate DNA sequence and structure for oncology testing. Through its Aventa clinical tests, biopharma partnerships and translational science collaborations, Arima detects clinically relevant fusions, rearrangements and structural mechanisms in solid tumors and lymphomas to refine diagnosis and guide therapy selection.

Gyros Protein Technologies Ab

Life Science Reagents

Gyros Protein Technologies, a division of Mesa Labs, provides Gyrolab® nanoliter-scale immunoassay platforms and PurePep® peptide synthesizers and purification technologies to accelerate biotherapeutic, cell and gene therapy, and vaccine development. Its instruments, reagents, and services support regulated bioanalytical and peptide workflows from discovery through manufacturing. Headquartered in Uppsala, Sweden, the company serves pharma, biotech, CRO, and CMO laboratories worldwide.

Automating Labs through Green Button Go

Diagnostics & Testing

Biosero is a lab automation specialist that powers more than 1,000 labs worldwide with its Green Button Go Scheduler and Orchestrator platform and integrated workcells. It connects instruments, software and teams into end‑to‑end workflows for diagnostics, therapeutics, genomics, cell biology, drug discovery and sample management, helping pharma and R&D buyers improve throughput, consistency and scientist productivity.

Biocrates

CRO & Clinical Services

Biocrates is a metabolomics-focused life science supplier providing standardized, quantitative mass spectrometry-based kits, software, and services for metabolic phenotyping. Headquartered in Innsbruck, Austria, the company’s portfolio enables robust measurement of hundreds to over a thousand metabolites across many biochemical classes, supporting biomarker discovery, clinical, nutritional, and systems biology research. Its mission is to make metabolomics accessible and reproducible for pharma, biotech, and

Biodesix

Diagnostics & Testing

Biodesix is a public U.S. diagnostic solutions company specializing in blood-based lung nodule risk assessment and lung cancer treatment guidance tests, alongside custom development services. Its Nodify Lung and IQLung testing strategies support personalized clinical decisions, while development services help biopharma and life sciences partners build and commercialize new diagnostics and therapeutics.

Biohithealthcare

CDMO & Manufacturing

Biohit Oyj is a Finnish public biotech and diagnostics company focused on innovative gastrointestinal diagnostics and disease prevention. Headquartered in Helsinki with subsidiaries in Italy and the UK, Biohit offers test systems such as GastroPanel and rapid GI tests, alongside monoclonal antibodies for research and diagnostic industry use.

Biological raw materials- Logical Biological

CDMO & Manufacturing

Logical Biological is a UK-based supplier of human biological raw materials founded in 2019. Headquartered at Discovery Park in Sandwich, Kent, the company provides serum, plasma, urine, saliva, swabs, PBMCs, and tissue specimens for IVD control manufacturing and diagnostic research. ISO 9001:2015 certified and Human Tissue Act licensed.

Biotech Fluidics

Diagnostics & Testing

Biotech Fluidics is a specialist supplier of liquid degassing and fluidic components for high‑precision analytical and processing systems. From its Swedish headquarters and global sales and manufacturing sites, it supports OEMs and laboratories in life science, diagnostics, chromatography and semiconductor manufacturing with degassers, inline monitoring tools, separation devices and flow components.

Broken String

Diagnostics & Testing

Broken String Biosciences is a private genomics technology company based at the Wellcome Genome Campus in Cambridge, UK, focused on genome-wide DNA break analysis for gene editing. Its BreakMap platform, powered by the PCR-free INDUCE-seq® assay and integrated bioinformatics, enables in-cell, unbiased detection of on- and off-target DNA breaks to support safer, regulator-ready development of cell and gene therapies.

CENTOGENE Guiding Precision Medicine

Diagnostics & Testing

CENTOGENE is a German precision medicine and genetic diagnostics company focused on rare and complex diseases, reproductive health, and oncology. It offers whole genome and exome sequencing, multiomic solutions, NGS panels, and non-invasive prenatal testing, underpinned by a biodatabank of over 1 million individuals and more than 350 publications. CENTOGENE also partners with pharma to use multiomic and real-world data to accelerate drug discovery and development.

Carb-X

CDMO & Manufacturing

CARB-X is a Boston University–led global non-profit accelerator focused on early-stage antibacterial R&D, funding new antibiotics, preventatives and rapid diagnostics against drug‑resistant bacteria. It provides non‑dilutive funding plus scientific, regulatory and business support to advance innovative products from basic research toward first‑in‑human studies, with a portfolio described as the world’s most diverse early antibacterial pipeline.

Cleveland Diagnostics

Life Science Reagents

Cleveland Diagnostics is a private oncology diagnostics company based in Cleveland, Ohio, focused on blood-based cancer tests built on its IsoClear™ protein structure platform. Its lead product, IsoPSA®, is an FDA‑approved assay for aiding detection of high‑grade prostate cancer and reducing unnecessary biopsies, supported by strong clinical evidence and guideline inclusion.

Frequently asked questions

What is an IVD supplier?
An in vitro diagnostic (IVD) supplier provides assays, instruments, or platforms used to detect biomarkers and support clinical or research testing.
How are diagnostic vendors used in clinical trials?
Sponsors use companion diagnostics, central lab services, and biomarker assays to stratify patients and measure trial endpoints.
What is a companion diagnostic development partner?
These vendors co-develop assays tied to a specific therapy, often under parallel FDA review pathways when the diagnostic is required for safe and effective use.
What should I look for in a diagnostics partner?
Regulatory clearance (FDA/CE), analytical validation data, throughput, and compatibility with your sample types and trial design.
Are LDT and research-use-only products distinguished?
Profiles summarize vendor scope; confirm intended use and regulatory status on the supplier's official documentation.
What is a biomarker assay vendor?
Vendors provide validated tests measuring protein, nucleic acid, or cellular biomarkers in clinical or preclinical samples, often supporting enrollment criteria or secondary endpoints.
Do profiles link to regulatory filings?
Where verifiable, profiles cite FDA, EMA, or official company regulatory pages in the sources section.
IVD supplier clinical trials: what to verify?
Confirm sample type, shipping stability, turnaround time, global kit logistics, and CDISC-friendly data delivery before locking central lab vendors in the protocol.
PCR diagnostic kit supplier vs NGS platform?
PCR kits offer targeted, rapid turnaround for known markers; NGS platforms enable broader profiling but add bioinformatics and storage complexity—match platform to hypothesis and regulatory path.
How do I browse diagnostics suppliers by application?
Use keyword tags and product tables on each profile, or browse related editorial coverage linked from supplier pages.

Last reviewed: · Data sources & methodology

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