ResearchDx
ResearchDx is a Contract Diagnostics Organization founded in 2008 and based in Irvine, California, providing integrated biomarker discovery, assay development, clinical validation, regulatory consulting, and GMP kit manufacturing to biopharmaceutical and diagnostic companies for companion diagnostic co-development.
- Company typePrivate
- Founded2008
- HeadquartersIrvine, United States
- Headcount11–50
- GTM typeB2B
- OfferingServices
What ResearchDx does
ResearchDx is a privately held Contract Diagnostics Organization (CDO) founded in 2008 by Philip D. Cotter, PhD, and Mathew W. Moore, PhD, and headquartered in Irvine, California. The company pioneered the CDO category, integrating biomarker discovery, custom assay development, clinical validation, regulatory affairs, and ISO 13485-compliant GMP kit manufacturing within a single organization. It operates through two wholly owned operating brands: PacificDx, a CLIA/CAP-accredited clinical and GLP-compliant molecular diagnostics laboratory offering NGS, ddPCR, flow cytometry, liquid biopsy, exosome isolation, and orthogonal validation services; and Custom Diagnostics (CustomDx), an ISO 13485:2016 and GMP-compliant manufacturing facility for custom diagnostic kits, reagents, and OEM assays.
ResearchDx serves pharmaceutical, biopharmaceutical, biotechnology, and diagnostic companies, with companion diagnostic co-development as its primary commercial use case. Revenue is generated through professional services (project-based contracts, milestone payments, consulting retainers) and hardware/manufacturing sales (GMP kit production and per-batch manufacturing contracts); pricing is custom-quoted per project with no public rate cards. GTM is enterprise sales-led via dedicated project managers, supported by conference presence (e.g., ASCO Annual Meeting), website content marketing, and SEO. Multiple 2024-2025 co-development partnerships (with Proteomics International, Targeted Genomics, Heranova, Vesica Health, HistoIndex, Prostatype Genomics, and Inoviq) have yielded FDA 510(k) clearance for the GlutenID test, a CPT PLA code approval for ProMarkerD, and CLIA/CAP accreditations for partner tests, evidencing active commercial momentum across celiac, endometriosis, bladder cancer, MASH, prostate cancer, and kidney disease verticals. The company operates with 11-50 employees and no disclosed external funding rounds.
ResearchDx firmographics
Firmographics- Name
- ResearchDx
- Legal name
- ResearchDx, Inc.
- Website
- https://researchdx.com
- Company type
- Private
- Founded year
- 2008
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- ResearchDx is a Contract Diagnostics Organization founded in 2008 and based in Irvine, California, providing integrated biomarker discovery, assay development, clinical validation, regulatory consulting, and GMP kit manufacturing to biopharmaceutical and diagnostic companies for companion diagnostic co-development.
- Ownership category
- akta.pro rank
ResearchDx industry classification
Industry- Product category
- Contract Diagnostics Organization (CDO) Services
- NAICS
- Medical and Diagnostic Laboratories (62151), Scientific Research and Development Services (5417), In-Vitro Diagnostic Substance Manufacturing (325413)
- SIC
- Services-Medical Laboratories (8071), Services-Commercial Physical & Biological Research (8731), In Vitro & In Vivo Diagnostic Substances (2835)
- akta.pro primary industry
- Companion Diagnostic (CDx) Co-Development Services (biopharma partnerships, clinical strategy) (HLAAAMAB)
- akta.pro secondary industries
- Companion Diagnostics (CDx) Development & Trial Testing Support (HLAGAEAJ), Companion Diagnostics (CDx) & Precision Medicine IVD (HLAHAAAJ), Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA)
Keywords
Where ResearchDx is headquartered
LocationHeadquarters
- HQ city
- Irvine
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
ResearchDx business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Technology or R&D, Operations, Infrastructure, Marketing or Sales
Revenue model
- Contract Diagnostic Development Services: Full-service contract research organization providing biomarker discovery, assay development, clinical trial consulting, regulatory filings, and GxP/CLIA testing services on a project or retainer basis for biopharma and diagnostic companies. Revenue generated through project fees, milestone payments, and consulting engagements.
- GMP Kit Manufacturing: ISO 13485:2016 and GMP-compliant custom diagnostic kit manufacturing, reagent production, and OEM assay manufacturing for clinical trials and commercial use. Revenue generated through product sales, manufacturing fees, and per-batch production contracts.
- Clinical Laboratory Testing Services: CLIA-licensed, CAP-accredited PacificDx laboratory providing clinical testing, esoteric testing, LDT commercialization, and contract testing services. Revenue generated through test fees per assay run and sample processing charges.
- Laboratory Consulting Services: Clinical laboratory consulting including CLIA/CAP accreditation guidance, turnkey startup services, mock audits, and regulatory submissions. Revenue generated through consulting fees and service contracts.
- Diligence and Assessments: Commercialization assessments and technical due diligence services for assay technology, organizations, company valuations, VC investment, and M&A purposes. Revenue generated through project-based consulting engagements.
Go-to-market motion2 records
Distribution channels2 records
Marketing channels5 records
ResearchDx product offering
Product offeringCore offering
ResearchDx is a Contract Diagnostics Organization (CDO) providing integrated end-to-end diagnostic development services for the biopharmaceutical and diagnostic industries. Its service portfolio spans biomarker discovery and validation, custom assay development (PCR, qPCR, ddPCR, NGS, flow cytometry, ELISA), GxP/CLIA testing, clinical trial consulting, regulatory affairs and submission support (510(k), PMA, EU MDR/IVDR), and ISO 13485/GMP-compliant custom diagnostic kit manufacturing. The company operates two core units—PacificDx (CLIA/CAP clinical laboratory) and CustomDx (GMP manufacturing)—enabling companion diagnostic co-development for novel therapeutics under a single-project-manager model.
Product overview
ResearchDx is a Contract Diagnostics Organization (CDO) that operates as a single, integrated organization offering comprehensive diagnostic development services from biomarker discovery through kit manufacturing and regulatory approval. The portfolio consists of two primary divisions: PacificDx, a CLIA/CAP/ISO 15189 accredited clinical laboratory providing testing services including NGS, PCR, flow cytometry, liquid biopsy, and exosome analysis; and CustomDx (Custom Diagnostics), an ISO 13485/GMP compliant manufacturing facility for diagnostic kit production. These divisions are supported by additional service lines including biomarker discovery and validation, assay development, bioinformatics, GxP/CLIA testing, regulatory consulting, clinical trial consulting, clinical laboratory consulting, orthogonal validations, and GMP manufacturing. The organization serves as a single-point-of-contact 'one-stop shop' for biopharmaceutical companies seeking integrated companion diagnostic development.
Differentiator
Problem solved
Functional benefit
Brands
- PacificDx: CLIA, CAP and GLP compliant molecular diagnostics laboratory providing clinical and non-clinical testing and pathology services
- Custom Diagnostics
Products and services
- PacificDx Clinical Laboratory A CLIA, CAP, and GLP compliant molecular diagnostics laboratory providing diverse clinical and non-clinical testing and pathology services to support biopharma, diagnostic, and medical professional client testing and IVD development needs.
- CustomDx (Custom Diagnostics) Manufacturing ISO 13485 and GMP compliant manufacturing facility for custom diagnostic kits, reagents, assays, and kit components for research, preclinical, and clinical applications.
- Biomarker Discovery & Validation Services Comprehensive biomarker discovery and validation services including molecular, protein, and other biomarkers for precision medicine applications in oncology, inflammatory/autoimmune, neurodegenerative, and metabolic diseases.
- Custom Assay Development Services Custom assay development supporting all test development including PCR, qPCR, ddPCR, NGS, microRNA, protein, Flow cytometry, and ELISA methodologies.
- GxP and CLIA Testing Services Pre-clinical testing under GxP or CLIA standards including neutralizing antibody assays, immune monitoring by flow cytometry, ELISAs, gene therapy viral tissue distribution, and gene editing therapy assessment.
- Next Generation Sequencing Services Comprehensive NGS services featuring Roche Avenio panels (Targeted, Expanded, Surveillance) and Illumina TSO500 for oncology applications including tumor profiling, liquid biopsy, and biomarker discovery.
- PCR, QPCR, RT-QPCR and ddPCR Services Amplification-based assay development and testing using multiple QPCR platforms (QuantStudioDx, QuantStudio 5 Dx, Quantstudio Flex, Qiagen RotorGene QMDx, BioRad CF96) and the QuantStudio Absolute Q Digital PCR System.
- Flow Cytometry Services Flow cytometry services using Beckman Coulter CytoFLEX S with 4 lasers (405 nm, 488 nm, 638 nm, 808 nm) for multiplex testing with up to 13 biomarkers, including CAR-T characterization and receptor occupancy assays.
- Liquid Biopsy Cancer Screening Cancer screening and early detection using circulating tumor DNA (ctDNA) and cell-free DNA (cfDNA) analysis from liquid biopsy samples using validated panels from Roche AVENIO and Illumina TSO platforms.
- EXO-NET Pan-Exosome Capture Services Immunoaffinity magnetic bead-based isolation system for exosome isolation from plasma, serum, urine, saliva, and cell-conditioned medium, licensed through Inoviq for exosome isolation and analysis services.
- Bioinformatics & Data Solutions Comprehensive bioinformatics solutions including biomarker identification, pathway analysis, multi-omics analysis, biostatistical modeling, clinical trial data analysis, and custom pipeline development and validation.
- Biorepository Services Sample tracking and storage with guaranteed chain of custody, redundant storage with generator backup, biospecimen processing including serum, plasma, buffy coat isolation, PBMC separation, DNA/RNA extraction, and cell isolation.
- GMP Manufacturing Services ISO 13485:2016 and GMP compliant custom diagnostic kit manufacturing including reagent manufacturing, kit assembly and packaging, ELISA kit production, and custom LDT kit manufacture.
- Regulatory Consulting Services Comprehensive regulatory affairs, clinical affairs, and quality assurance services including FDA submissions (510(k), PMA, IDE, IND, De Novo), international regulatory filings (EU MDR, IVDR), and quality system support.
- Clinical Laboratory Consulting Virtual clinical laboratory hosting, CLIA/CAP/ISO 15189 accreditation consulting, and turnkey CLIA certification services including mock inspections, deficiency corrections, and laboratory director provision.
- Clinical Trial Consulting Full clinical trial consulting and program support including clinical program support, trials support, data management, biostatistics, and clinical laboratory support for preclinical and clinical studies.
- Orthogonal Validations Orthogonal validation services for analytical validation requirements including comparison studies using validated NGS panels, Sanger sequencing, qPCR, ddPCR, ELISA, and FACS methodologies.
- Companion Diagnostics Development Integrated companion diagnostic (CDx) development services from concept through regulatory approval, solving logistical complexities of multi-partner outsourcing for regulated CDx development.
- Diligence and Assessments Commercialization assessment and technical due diligence services for company valuations, angel and venture capital investment, and mergers and acquisitions including marketability, funding, patenting, and regulatory requirements analysis.
Quantifiable outcome
- Over 300 new assays validated and millions of tests performed since 2015
- +2 more outcomes
Companies that use ResearchDx
Customer profileNamed customers4 records
Segments4 records
Ideal customer profiles4 records
ResearchDx technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature6 records
ResearchDx partnerships and signals
Strategic signalPartnerships
Seven partnerships are on record, tiered core and minor.
- Proteomics International Laboratories Ltd (ASX: PIQ)coreResearchDx DBA PacificDx partnered with Proteomics International Laboratories Ltd to commercialize ProMarkerD, a predictive test for diabetic kidney disease. The partnership achieved American Medical Association approval of a dedicated CPT Proprietary Laboratory Analyses (PLA) code, a key step toward Medicare and private insurer reimbursement in the United States. Testing is performed at PacificDx's CLIA/CAP accredited facility in Irvine, CA.
- Targeted GenomicscoreResearchDx and Targeted Genomics collaborated on GlutenID Celiac Genetic Health Risk Test, which received FDA 510(k) clearance (K241456). Testing is performed at ResearchDx's PacificDx facility. This represents a co-development and commercialization partnership for a novel celiac disease genetic test.
- HistoIndexminorFibroSIGHT, developed by HistoIndex, is offered through PacificDx for clinical care of MASH patients. FibroSIGHT enables sensitive detection and visualization of MASH liver fibrosis, eliminating variability associated with traditional staining techniques. PacificDx provides the clinical testing service.
- Prostatype GenomicsminorProstatype Genomics received CAP laboratory accreditation through PacificDx, achieving a milestone toward entering the US market for their Prostatype Gene Test. PacificDx provides CLIA/CAP accredited laboratory services for the test's US commercial launch.
- HeranovaminorHeranova achieved CLIA certification and early access launch of HerResolve, a potential first FDA-cleared non-invasive endometriosis test. ResearchDx supported the CLIA certification process as part of its laboratory consulting services.
- Vesica HealthminorVesica Health launched AssureMDx test to improve bladder cancer detection. ResearchDx's PacificDx laboratory provides testing services for the AssureMDx assay as part of a laboratory partnership.
- InoviqcoreResearchDx entered a licensing agreement with Inoviq to offer EXO-NET Pan-Exosome Isolation and Analysis services in the United States. ResearchDx is a certified provider of EXO-NET exosome sequencing services. This licensing arrangement grants ResearchDx rights to offer Inoviq's proprietary exosome isolation technology to US clients.
Scale indicators4 records
Recent moves6 records
Expansion highlights5 records
ResearchDx competitors and assessment
Company assessmentDirect peers
- Frontage Laboratories: Frontage is a CRO/CDMO offering bioanalytical, biomarker, and clinical lab services to biopharma including CMC and GMP capabilities, closely paralleling ResearchDx's integrated contract diagnostics and GMP kit manufacturing model.
- NeoGenomics: NeoGenomics operates a global oncology-focused clinical lab and CDx services business spanning biomarker discovery, assay development, and CLIA-validated testing — overlapping directly with ResearchDx's PacificDx and CDx co-development offerings. Co-founder Mathew Moore was previously VP of R&D at NeoGenomics.
- Q² Solutions (IQVIA): Q² Solutions is a central/clinical trial lab services provider with a dedicated companion diagnostics franchise, directly competing for biopharma CDx co-development and trial testing engagements that ResearchDx targets.
- Biocept: Biocept provides CLIA-validated liquid biopsy oncology testing and CDx services, directly comparable to PacificDx's liquid biopsy, ctDNA, and CDx development work. Co-founder Philip Cotter previously served as VP and Laboratory Director at Biocept.
Broad incumbents
- Medpace: Medpace is a mid-to-large CRO with significant central lab and biomarker capabilities, competing for biopharma clinical trial testing and CDx development budgets with a more limited CDx focus than ResearchDx.
- Eurofins Genomics: Eurofins operates a large global network of IVD development, genomics, and CDx-capable laboratories serving pharma and diagnostic companies, providing overlapping capabilities with ResearchDx's PacificDx and CustomDx at greater scale and geographic reach.
- Charles River Laboratories: Charles River provides CRO, CDMO, and preclinical/postmarket lab services including diagnostic and biomarker capabilities, positioning it as a larger integrated services incumbent adjacent to ResearchDx's CDO model.
- ICON plc: ICON is a global CRO with central lab and bioanalytical services that compete for the same biopharma CDx and molecular diagnostic development engagements ResearchDx serves, though at substantially greater scale.
- Labcorp Drug Development: Labcorp (including its Covance/Fortrea heritage) offers end-to-end CDx development, central lab services, and IVD commercialization to global biopharma — a much larger incumbent competing for the same companion diagnostic co-development budgets.
Emerging players
- Inotiv: Inotiv is a CRO with contract research, diagnostic, and lab services for pharma/biotech, providing a comparable but less CDx-specialized alternative for biomarker, assay, and lab testing work that overlaps with ResearchDx's offerings.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights7 records
Customer concentration
ResearchDx social profiles
Digital presenceResearchDx compliance and trust
Trust signalCompliance13 records
ResearchDx financial estimates
Financial estimateRevenue estimate
Valuation estimate
ResearchDx leadership team
Management profileNumber of profiles
Profiles6 records
ResearchDx subsidiaries and ownership
Company hierarchySubsidiaries2 records
ResearchDx funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
ResearchDx M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about ResearchDx
What does ResearchDx do?
ResearchDx is a Contract Diagnostics Organization (CDO) providing integrated end-to-end diagnostic development services for the biopharmaceutical and diagnostic industries. Its service portfolio spans biomarker discovery and validation, custom assay development (PCR, qPCR, ddPCR, NGS, flow cytometry, ELISA), GxP/CLIA testing, clinical trial consulting, regulatory affairs and submission support (510(k), PMA, EU MDR/IVDR), and ISO 13485/GMP-compliant custom diagnostic kit manufacturing. The company operates two core units—PacificDx (CLIA/CAP clinical laboratory) and CustomDx (GMP manufacturing)—enabling companion diagnostic co-development for novel therapeutics under a single-project-manager model.
Is ResearchDx a public or private company?
ResearchDx is a private company. It is classified as management employee owned and is currently operating.
When was ResearchDx founded?
ResearchDx was founded in 2008. It employs 11 to 50 people.
Where is ResearchDx based?
ResearchDx is headquartered in Irvine, United States, in the North America region.
How does ResearchDx make money?
Five revenue lines are on record. Contract Diagnostic Development Services are the primary driver. The others are GMP Kit Manufacturing, clinical Laboratory Testing Services, laboratory Consulting Services and diligence and Assessments.
Who are ResearchDx's main competitors?
Direct peers on record are Frontage Laboratories, NeoGenomics, Q² Solutions (IQVIA) and Biocept. Broad incumbents are Medpace, Eurofins Genomics, Charles River Laboratories, ICON plc and Labcorp Drug Development. Inotiv is listed as an emerging player.
Does ResearchDx have an API?
No public API is recorded for ResearchDx.
What industry is ResearchDx in?
ResearchDx's product category is Contract Diagnostics Organization (CDO) Services. Its primary akta.pro industry code is HLAAAMAB, Companion Diagnostic (CDx) Co-Development Services (biopharma partnerships, clinical strategy), with a secondary code of HLAGAEAJ, Companion Diagnostics (CDx) Development & Trial Testing Support. Its NAICS code is 62151 and its SIC code is 8071.