Geneuity Clinical Research Services

What Geneuity Clinical Research Services does

Geneuity Clinical Research Services is a privately held clinical trial laboratory testing provider operating as a DBA wholly owned by Molecular Pathology Laboratory Network, Inc. (MPLN), headquartered in Maryville, Tennessee. Founded as a dedicated biopharma-facing entity in 2023, the company delivers project management, data management, and commercial operations services for Phase I-IV clinical trials conducted by biopharma sponsors and contract research organizations, with MPLN's CAP/CLIA and ISO 15189 accredited laboratory performing all specimen handling and testing.

The company's core product is integrated multi-modal diagnostic testing spanning cytogenetics and FISH (40+ loci), immunohistochemistry and multiplex IHC (200+ validated antibodies), molecular oncology including DNA sequencing (WGS, WGMS, WES, TSO Comp), RNA sequencing (Total RNA-Seq, mRNA), and liquid biopsy (PGDx elio plasma complete), anatomic pathology, flow cytometry, and digital pathology. Therapeutic expertise covers solid tumor oncology (NSCLC, head and neck, prostate, breast, ovarian), hematopathology (AML, MDS, CLL, multiple myeloma), and additional subspecialties including GI pathology, dermatopathology, immunology, and rare diseases. A cloud-based digital pathology platform enables centralized image review by multiple pathologists simultaneously, and a global network of accredited partner laboratories extends testing capacity for international studies. KOL partners provide subspecialty consultation across gastrointestinal, kidney, liver, urology, cytology, and dermatopathology.

Geneuity generates revenue through negotiated clinical trial contracts with biopharma companies and CROs, priced on a per-study and per-test basis with separate setup and project management fees. The company targets enterprise biopharma buyers through direct consultative sales, supported by dedicated project managers, an in-house data management and LIS team providing customized exports, and a 'Connect with an Expert' lead capture channel. To date, the company has completed over 400 Phase I-IV research studies across more than two decades of clinical trial support activity.

Name

Geneuity Clinical Research Services

Legal name

Molecular Pathology Laboratory Network, Inc.

Website

https://geneuity.com

Company type

Private

Founded year

1991

Operating status

Operating

Headcount range

51–100 employees

Short description

Geneuity Clinical Research Services is a privately held clinical trial laboratory testing provider serving biopharma companies and CROs with CAP/CLIA/ISO 15189 accredited molecular diagnostics, cytogenetics, IHC, genomic, and digital pathology services for Phase I-IV studies.

Ownership category

akta.pro rank

Product category

Clinical Research Laboratory Services

NAICS

Medical Laboratories (621511), Medical and Diagnostic Laboratories (6215)

SIC

Services-Medical Laboratories (8071)

akta.pro primary industry

Genomics & Molecular Diagnostics (Trial Support) (HLAGAEAD)

akta.pro secondary industries

Molecular & Genetic Testing (PCR/NGS/qPCR) (HLAGADAF), Molecular Diagnostics & Genomics Laboratories (HLAFAMAE), Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC), Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB)

Keywords

• Clinical trial laboratory services
• Molecular pathology testing
• Centralized diagnostic testing
• Biomarker validation services
• IVD clinical research

Headquarters

HQ city

Maryville

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 Testing Services: Provides comprehensive diagnostic testing services for Phase I-IV clinical trials including molecular oncology, cytogenetics, FISH, IHC, and anatomic pathology testing. Revenue is generated through contracted clinical trial agreements with biopharma clients, typically based on per-test pricing, study setup fees, and project management fees.
2. Project Management Services: Dedicated project managers assigned to each clinical trial study, providing regulatory-compliant testing coordination, timeline management, and data delivery support. Studies typically set up within 8-12 weeks of contract signature.
3. Data Management Services: Customized data management services including data exports in agreed formats, custom data solutions via in-house software development team, and real-time reporting for patient management.
4. Validation Services: Fully customizable validation services across all testing areas to support novel and exploratory biomarker assessments for research and development (R&D) and in vitro diagnostic (IVD) study laboratory testing.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels3 records

Core offering

Geneuity Clinical Research Services is a DBA wholly owned by Molecular Pathology Laboratory Network, Inc. (MPLN) that provides centralized laboratory testing and clinical trial support services for Phase I-IV research studies. Its offerings span molecular diagnostics, cytogenetics and FISH, immunohistochemistry, flow cytometry, digital pathology, genomic solutions (DNA, RNA, liquid biopsy), and validation services for novel biomarkers, delivered from a CAP/CLIA/ISO 15189 accredited laboratory in Maryville, Tennessee.

Product overview

Geneuity Clinical Research Services is a DBA wholly owned by Molecular Pathology Laboratory Inc (MPLN) providing a comprehensive suite of clinical trial support services. The portfolio includes core services for Project Management, Data Management, and Commercial Operations, supported by MPLN's CAP/CLIA/ISO15189 accredited laboratory. The diagnostic service offerings span Cytogenetics & FISH Testing, Central Pathology Expertise, Genomic Solutions (DNA, RNA, and Liquid Biopsy), Digital Pathology, IHC & Multiplex IHC, and Global Logistics. Additional support services include a KOL Network of global pathologists and Validation Services for novel biomarker assessments. The platform integrates multiple testing modalities—molecular oncology, cellular immunology, cytogenomics, and anatomic pathology—to support patient recruitment, stratification, and safety monitoring across Phase I-IV clinical trials.

Differentiator

Problem solved

Functional benefit

Products and services

• Clinical Trial Support Comprehensive clinical trial support encompassing project management, data management, and commercial operations for Phase I-IV research studies with CAP/CLIA/ISO15189 accredited laboratory testing, serving biopharma and clinical research clients.
• Project Management Dedicated project managers with scientific backgrounds manage complex research-based clinical trials, collaborating with scientific operations, client services, and commercial operations teams to deliver regulatory-compliant testing results on time.
• Data Management Data management services providing accurate, clean, quality data in customized formats exported from an in-house laboratory information system (LIS), with real-time reports and guaranteed data integrity.
• Cytogenetics & FISH Testing Chromosome analysis and fluorescent in situ hybridization (FISH) testing with over 40 loci and disease-specific panels detecting gene amplifications, deletions, translocations, and inversions for oncology, infertility, and congenital disorders.
• Central Pathology Expertise Multi-modal testing integrating pathology, molecular diagnostics, cytogenetics, FISH, immunohistochemistry, and flow cytometry for fully integrated diagnostic and central review services for global Phase I-IV clinical trials.
• Genomic Solutions Genomic testing including DNA solutions (WGS, WGMS, WES, TSO Comp, Pillar OncoReveal), RNA solutions (Total RNA-Seq, RNA exome, mRNA), and liquid biopsy solutions (PGDx elio plasma complete) for precision oncology.
• Digital Pathology Cloud-based image management platform providing seamless access to digital images, validated diagnostic workflows, digital imaging workflows, and centralized review capabilities with simultaneous pathologist viewing.
• IHC & Multiplex IHC Over 200 IHC antibodies validated for clinical trials with simultaneous visualization of multiple biomarkers within the same tissue section, supporting biomarker discovery and clinical trials.
• Global Logistics Partnerships with global specialist couriers and large integrators supporting specialty shipping with ambient, refrigerated, frozen, and liquid nitrogen storage and shipment services with real-time tracking.
• KOL Network Global network of specialty pathologists and key opinion leader (KOL) partners supporting centralized pathology expertise across gastrointestinal, kidney, liver, urology, cytology, and dermatopathology.
• Validation Services Fully customizable validation services across all testing areas to support novel and exploratory biomarker assessments for research and development (R&D) and in vitro diagnostic (IVD) study laboratory testing.

Quantifiable outcome

• 400+ Phase I-IV research studies completed
• +3 more outcomes

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Three partnerships are on record, tiered core and minor.

• Global Network of Accredited LaboratoriescoreStrategic or Co-development PartnerGeneuity partners with a trusted and accredited network of laboratories across the globe to support global clinical studies, providing centralized and harmonized testing solutions. Services are fully harmonized at accredited partner labs to support global clinical trials.
• KOL Partners (Key Opinion Leaders)coreStrategic or Co-development PartnerGeneuity expands its network of experts using trusted KOL partners for pathology consultation and centralized review services in clinical trials.
• Global Specialty Couriers and Large IntegratorsminorStrategic or Co-development PartnerPartnerships with global specialist couriers and large integrators to support global studies and specialty shipping requirements for clinical trial specimens.

Scale indicators5 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• ACM Global Central Laboratory: ACM Global is a specialty central lab offering molecular diagnostics and clinical trial testing services to biopharma, similar in scale and focus to Geneuity's molecular pathology central lab offering.
• Q² Solutions: Q² Solutions is a leading global clinical trial central laboratory providing molecular, genomic, and specialty testing for biopharma sponsors, directly comparable to Geneuity's central lab and biomarker services for Phase I-IV trials.
• NeoGenomics: NeoGenomics provides oncology-focused clinical trial laboratory services including molecular testing, FISH, IHC, and genomic profiling, directly competing with Geneuity's oncology biomarker testing menu.
• Medpace Laboratories: Medpace operates a central laboratory offering clinical trial testing services with global reach for biopharma sponsors, comparable as a clinical trial central lab with similar biomarker capabilities.
• ICON Central Laboratories: ICON Central Labs provides global centralized laboratory testing and biomarker services for clinical trials across multiple therapeutic areas, directly competing for biopharma central lab work like Geneuity.
• CellCarta (formerly Caprion): CellCarta is a specialty central lab offering histology, IHC, multiplex imaging, and flow cytometry for biopharma clinical trials, directly comparable to Geneuity's specialty pathology and biomarker testing capabilities.

Emerging players

• Bio-Techne: Bio-Techne provides specialty reagents and reference lab services including GMP-grade proteins, assays, and exosome diagnostics for clinical research, an adjacent emerging player in specialty clinical trial testing.
• Guardant Health: Guardant Health provides liquid biopsy and genomic profiling services for oncology clinical trials and precision medicine, an emerging player in next-gen molecular testing used in biopharma trials.
• Personalis: Personalis offers genomic sequencing and molecular diagnostic services for biopharma clinical trials and companion diagnostic development, an emerging player with comparable NGS-based clinical trial services.

Broad incumbents

• Labcorp Central Laboratory Services: Labcorp's central lab services division offers global clinical trial testing including molecular diagnostics and specialty biomarker assays across a much broader footprint, making it a broad incumbent comparable on central lab capabilities.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

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 Geneuity Clinical Research Services