Diagnostics, IVD & Companion Diagnostic Development Vendors

Vendors supporting IVD, molecular diagnostic and companion diagnostic development from assay design and validation through clinical performance studies and manufacturing scale-up.

Workflows in this category

Favicon of DCN Dx

CDMO / CMO · +5 more types

DCN Dx is an IVD CDMO and CRO providing assay development, clinical trial operations, regulatory support, and manufacturing services.

Products: miniDxR, MICA-200C +1 more

Evidence-backed workflow match
Matches IVD Assay Development
“From initial feasibility studies to optimization, validation, and manufacturing, we provide expert support at every stage of your lateral flow assay lifecycle. Whether you require…”
Source: dcndx.com

Also offers: IVD Manufacturing & Scale-Up, IVD Clinical Study Operations, +1 more

Crown Bioscience is a translational oncology CRO offering in vivo efficacy studies, PDX and cancer models, biomarker discovery, and clinical biomarker testing.

Products: OrganoidXplore, HuGEMM +3 more

Evidence-backed workflow match
Matches Companion Diagnostic Development
“De-risk therapeutic development through early identification of candidate biomarkers and clinical evaluation of companion diagnostics (CDx, Japanese market only).”
Source: crownbio.com

Also offers: In Vivo Pharmacology & Efficacy Models, Oncology Models & PDX Studies, +2 more

Medix Biochemica is an IVD raw material supplier offering antibodies, antigens, molecular diagnostic reagents and human biospecimens.

Products: MedixMDx, HiDi +1 more

Evidence-backed workflow match
Matches IVD Assay Development
“Medix Biochemica offers tailored contract development solutions, leveraging our extensive expertise to transform your ideas into market-ready products efficiently.”
Source: medixbiochemica.com

Also offers: Antibodies, Immunoassay & Cell Analysis Reagents, Proteins, Peptides, Enzymes & Growth Factors, +2 more

Voisin Consulting Life Sciences provides regulatory, clinical, pharmacovigilance, market access and development services.
Evidence-backed workflow match
Matches IVD & Companion Diagnostic Development Strategy
“Comprehensive support for every phase of IVD and CDx development, from early-stage biomarker identification and assay development to clinical trials and regulatory submissions.”
Source: voisinconsulting.com

Also offers: Regulatory Development Strategy & Agency Interactions, Market Access Strategy & Launch Planning, +3 more

Veristat is a specialty CRO providing biostatistics, clinical data management, and regulatory strategy and writing services.

Products: InStat, CoAuthor

Evidence-backed workflow match
Matches IVD & Companion Diagnostic Development Strategy
“Proven regulatory advice, planning, and operational support for medical devices (MDs), in vitro diagnostics (IVDs), and companion diagnostics (CDx) across the EU, US, and Canada.”
Source: veristat.com

Also offers: Biostatistics & Statistical Programming, Full-Service Clinical Trial Execution (CRO Services), +3 more

Frontage Laboratories is a CRO and CDMO providing bioanalysis, DMPK and ADME studies, toxicology, Phase I support, and drug manufacturing.
Evidence-backed workflow match
Matches Diagnostic Biomarker Development & Validation
“We work in consultation with customers to develop a tiered approach to validation depending on the needs of the program or phase of development of the biomarker.”
Source: frontagelab.com

Also offers: Bioanalysis & Biomarker Assay Services, Integrated CDMO/CMO Services, +3 more

Altasciences is an early phase CRO and CDMO providing toxicology, IND-enabling studies, clinical pharmacology, bioanalysis, and drug manufacturing.

Products: Acceleration Platform

Evidence-backed workflow match
Matches Immunoassay Development
“With experience in a wide range of sample types—from plasma and serum to cerebrospinal fluid and tissues from various animal models—we’re prepared to develop custom immunoassay…”
Source: altasciences.com

Also offers: Toxicology Studies, First-in-Human (Phase I) Clinical Pharmacology Support, +2 more