Navigate BioPharma

Name

Navigate BioPharma

Legal name

Navigate BioPharma Services, Inc.

Website

https://navigatebp.com

Company type

Private

Founded year

2017

Operating status

Operating

Headcount range

101–250 employees

Ownership category

akta.pro rank

Product category

Specialty Clinical Laboratory Services

NAICS

Medical Laboratories (621511), Medical and Diagnostic Laboratories (62151)

SIC

Services-Medical Laboratories (8071), In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB)

akta.pro secondary industries

Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC), Multiplex & High-Throughput Diagnostics Platforms (microarrays, digital PCR, lab automation-enabled assays) (HLAAALAL), Translational Medicine & Biomarkers (HLAIALAF)

Keywords

• Clinical trial biomarkers
• Companion diagnostics
• Flow cytometry services
• Digital pathology assays
• Immunoassay development

Headquarters

HQ city

Carlsbad

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure, Supply Chain

Revenue model

1. Clinical Trial Laboratory Services: Laboratory testing services for clinical trials including biomarker identification, pharmacodynamics, efficacy readouts, patient inclusion, and disease diagnosis/prognosis. Services are customized per client with end-to-end support.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels5 records

Core offering

Navigate BioPharma is a specialty clinical research organization providing biomarker laboratory services and clinical trial testing to pharmaceutical, biotech, and diagnostic sponsors. Its core offerings span four technology platforms—flow cytometry, digital pathology, genomic, and ligand binding immunoassays—delivered as end-to-end services including assay development, biomarker identification, pharmacodynamic and efficacy readouts, MRD monitoring, immune profiling, and companion diagnostic development and regulatory support.

Product overview

Navigate BioPharma Services is a specialty clinical research organization providing biomarker solutions and laboratory services for clinical trials. The company operates a multi-platform portfolio consisting of four core specialty lab service areas (Flow Cytometry, Digital Pathology, Genomic, and Ligand Binding), supported by Immune Profiling capabilities and clinical trial services (Clinical Trial Testing, Project Management, Laboratory Data Management, Quality Assurance, and Regulatory Support). Biomarker Services, Bioanalytical Services, and Diagnostics Support Services sit atop these platforms, delivering pharmacodynamic, immunogenicity, and companion diagnostic solutions. Key specialized sub-products include Spectral Flow TNK Profiling for immunotherapy monitoring, AML-MRD and CLL-MRD flow cytometry assays for measurable residual disease detection, plasma immunoassay panels for Alzheimer's disease, and alpha-synuclein assays for Parkinson's disease. The company is a Novartis subsidiary headquartered in Carlsbad, CA.

Differentiator

Problem solved

Functional benefit

Products and services

• Biomarker Services Pharmacodynamic biomarker analysis services including predictive, mechanism of action (MOA), and efficacy endpoint assessments for clinical trials conducted across pharmaceutical, biotech, and diagnostic sponsors.
• Bioanalytical Services Immunogenicity testing, cellular kinetics, receptor occupancy, potency, and tetramer analyses for clinical development programs supporting drug and biologic approvals.
• Diagnostics Support Services Companion diagnostic development under design control, analytical validation (IDEs), clinical validation, and PMA submissions support for in vitro diagnostic manufacturers.
• Flow Cytometry Services Advanced flow cytometry services for biomarker discovery, immune monitoring, and cell therapy development including spectral flow cytometry and MRD assays, offered to pharmaceutical and biotech sponsors.
• Digital Pathology Services Digital pathology assays including multiplex detection, AQUA platform for automated quantitative biomarker analysis, and immuno-oncology biomarker panels for tumor and immune cell biology analysis.
• Genomic Services Genomic solutions including target enumeration for CAR-T therapy, VSVG and RCL testing, VCN validation, next-generation sequencing, digital PCR, and RNAi quantification.
• Ligand Binding Immunoassay Services Ligand-binding immunoassay solutions using Beckman Coulter DxI 9000, MSD MESO SECTOR S 600MM, SpectraMax iD5e, Ella, FLEXMAP 3D, and Octet SF3 platforms for pharmacodynamic and immunogenicity endpoints.
• Immune Profiling Services Comprehensive immune monitoring including measurable residual disease (MRD) detection by flow cytometry and next-generation sequencing, immunogenicity assays, and lymphocyte subset profiling.
• Clinical Trial Testing Services End-to-end clinical trial testing services including biomarker identification, pharmacodynamics, efficacy readouts, patient inclusion, and disease diagnosis for pharmaceutical, biotech, and diagnostic sponsors.
• Multiplex Digital PCR Assay for CAR-T Transgenes Multiplex digital PCR assay for comprehensive quantification of up to five different CAR-T transgenes, enabling multiplexed transgene quantification for next-generation CAR-T products and cell therapy development.
• Spectral Flow TNK Profiling 28-parameter comprehensive T cell and NK cell assay using spectral flow cytometry for evaluating functional states of T cells and NK cells in immunotherapy clinical trials.
• AML-MRD (Acute Myeloid Leukemia Measurable Residual Disease) Assay Multiparametric flow cytometry test using ELN-consensus markers for MRD monitoring in AML patients, with 0.1% sensitivity cutoff per ELN AML-MRD working party guidelines.
• CLL-MRD (Chronic Lymphocytic Leukemia Minimal Residual Disease) Assay Flow cytometry-based MRD test using internationally harmonized markers for CLL monitoring with 0.01% sensitivity (1 in 10,000 cells) and 96% qualitative concordance to reference laboratory.
• Plasma Immunoassay Panel for Alzheimer's Disease Validated plasma biomarker panel using Beckman Coulter DxI 9000 platform for p-Tau217, GFAP, NfL, APOE4, and Aβ1-42 detection in neurodegenerative clinical research.
• Alpha-Synuclein (α-Synuclein) IDE/IVDR Assay Quantitative electrochemiluminescence immunoassay for alpha-synuclein detection in CSF for Parkinson's Disease pharmacodynamic monitoring under IDE/IVDR pathways.

Quantifiable outcome

• 4-fold less specimen consumption with 8-fold more data (4 million phenotypes) using spectral flow cytometry
• +3 more outcomes

Named customers4 records

Segments3 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Eight partnerships are on record, tiered core and supporting.

• BD (Becton, Dickinson and Company)coreStrategic or Co-development PartnerNavigate BioPharma announced collaboration with BD to advance capabilities for clinical phases of drug development. The partnership aims to enhance laboratory capabilities and develop new solutions for pharmaceutical and biotech clients.
• QiagensupportingTechnology or IntegrationQiagen partnered with Navigate BioPharma on a webinar covering multiplex dPCR solutions for next-generation CAR T products, demonstrating technical collaboration on assay development.
• Beckman Coulter, Inc.supportingTechnology or IntegrationNavigate utilizes Beckman Coulter DxI 9000 Immunoassay Analyzer platform for high-sensitivity, high-throughput automation for routine and complex immunoassays including Alzheimer's disease biomarker panels.
• Meso Scale Diagnostics, LLC (MSD)supportingTechnology or IntegrationNavigate utilizes MESO SECTOR S 600MM platform for multiplex electrochemiluminescence detection for cytokine profiling and biomarker quantification.
• Sartorius AGsupportingTechnology or IntegrationNavigate utilizes Octet SF3 Surface Plasmon Resonance system for accurate measurement of molecule kinetics and affinity from a single analyte concentration.
• Molecular Devices, LLCsupportingTechnology or IntegrationNavigate utilizes SpectraMax iD5e Multi-Mode Microplate Reader for absorbance, fluorescence, and luminescence-based assays.
• Bio-Techne Ltd.supportingTechnology or IntegrationNavigate utilizes Ella Automated ELISA Platform for hands-free, cartridge-based ELISA system for rapid and precise protein quantification.
• Luminex CorporationsupportingTechnology or IntegrationNavigate utilizes FLEXMAP 3D Instrument System capable of simultaneously measuring up to 500 genes or proteins from a small sample using magnetic and non-magnetic microspheres.

Scale indicators4 records

Recent moves9 records

Expansion highlights5 records

Direct peers

• NeoGenomics: Specialty oncology and clinical trial biomarker laboratory offering flow cytometry, molecular, and pathology services to pharma and biotech sponsors. Highly comparable to Navigate's oncology-focused trial testing model and CAR-T/MRD expertise.
• Q² Solutions: Central laboratory joint venture (IQVIA/Quest) providing clinical trial biomarker and specialty lab services globally. Competes head-to-head with Navigate for multi-platform trial biomarker work, with broader geographic reach.
• Cerba Research: Specialty and central lab focused on clinical trial biomarker services including flow cytometry, genomics, and immunoassays. Comparable mid-sized specialty lab positioning with cross-modality capabilities similar to Navigate.

Broad incumbents

• Labcorp Central Laboratory Services: Global central lab within Labcorp offering a broad biomarker and specialty testing menu for clinical trials. A larger, more diversified incumbent competing for the same pharma/biotech project pipeline Navigate targets.
• Eurofins Central Laboratory: Global central and specialty lab serving pharma and biotech with biomarker, genomic, and immunoassay testing. Comparable to Navigate in assay menu but materially larger in geographic footprint and scale.
• ICON Laboratory Services: Clinical trial central lab and biomarker services within ICON plc, supporting pharma sponsors globally. Competes for specialty biomarker and CDx work that Navigate also pursues, with greater geographic redundancy.
• Charles River Laboratories: Global CRO with a discovery and safety assessment lab services business that includes biomarker and immunoassay capabilities. Larger, more diversified player with overlapping specialty lab offerings for clinical development.
• SYNLAB Group: European-headquartered clinical diagnostics and trial-supporting lab network offering biomarker and specialty testing services. Adjacent competitor for global pharma trial work, with stronger European footprint.
• Pharmaceutical Product Development (PPD, Thermo Fisher): Global CRO with central lab and biomarker services within Thermo Fisher. Competes for the same enterprise pharma trial testing demand Navigate serves, with materially greater scale.

Emerging players

• Bionova Scientific (GenScript ProBio): Specialty bioanalytical and biomarker services provider supporting cell and gene therapy developers. Comparable to Navigate in its cell/gene therapy focus, but with a distinct bioanalytical/CGT development orientation.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/navigatebp

Compliance10 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Navigate BioPharma