What Hemogenix® does

Hemogenix® is a contract research organization (CRO) founded in 2000 and headquartered in Colorado Springs, Colorado, specializing in proprietary in vitro toxicity testing and cell biology services for the biopharmaceutical industry. The company's technology is built on Suspension Expansion Culture™ (SEC™) Technology coupled with ATP bioluminescence signal detection (using third-party Promega reagents such as CellTiter-Glo®), and is delivered through eleven tissue- and cell-type-specific assay platforms: HALO®-Tox HT (hematotoxicity), ImmunoGlo™ (immunotoxicity), MSCGlo™-Tox HT (mesenchymal stem cells), HepatoGlo™-Tox HT (hepatotoxicity), CardioGlo™-Tox HT (cardiotoxicity), RenalGlo™-Tox HT (nephrotoxicity), NeuroGlo™-Tox HT (neurotoxicity), SkinGlo™-Tox HT (skin toxicity), EpiGlo™-Tox HT (intestinal toxicity), CellaGlo™-Tox HT (tumor cells), and STEMGlo™-Tox HT (ES/iPS/transformed cell lines). These are integrated into the ComparaTOX™ multi-tissue comparative platform (available in HT and FS formats) and supplemented by HemaToxFlow™ (flow cytometry-based hematotoxicity), cellular therapy potency and QC assays (HALO® SC-IPS, MSCGlo™ SC-IPS, STEMpredict™, HALO® QC, HALO® TE, HALO® PMT), mechanism-of-action studies, IND-enabling assays, and a Nanoparticle In Vitro Toxicity Panel. HALO®-Tox HT and HALO® SC-IPS are validated according to FDA Bioanalytical Method Validation Guidelines, have FDA Master Files, and HALO®-Tox HT shows 82% in vitro-to-in vivo concordance (Olaharski et al., 2009) and validation against the NIH/ICCVAM Registry of Cytotoxicity Prediction Model.

The company serves small, medium, and large biopharmaceutical companies, with disclosed penetration of more than half of the top 50 global biopharma, and reports that study results have been included in numerous FDA IND applications. Customers engage HemoGenix on a fee-for-service contract basis; there is no subscription or recurring revenue model. Three study formats are offered: a customized full-service study with Study Plan, Phase I Draft Report, Phase II Final Report, and QA audit (suitable for IND submissions, billed under multi-year contract structures); a rapid toxicity study delivering raw data and protocol in an Excel workbook (pay-as-you-go); and a high-throughput screening module priced in multiples of 5 compounds per tissue (pay-as-you-go). Distribution is direct (one-on-one consultation, email/phone engagement at [email protected]) and indirect, through listing on the Scientist.com and Science Exchange pharmaceutical outsourcing marketplaces and the Thermo Fisher Scientific Service Marketplace.

The company's go-to-market is sales-led and account-based, leveraging peer-reviewed publications, scientific conference presentations (AABB, ISCT, Society of Toxicology, Cord Blood Symposium), white papers, and marketplace presence to reach biopharma procurement and preclinical safety teams. Preferred Cell Systems™ operates as a sister company that sells the same proprietary assay platforms as kit products ("Assays-in-a-Box™") and licenses them to sponsors who prefer in-house testing, extending revenue capture beyond pure service work. The company has received two NCI SBIR grants (2002 and 2005) to develop the HALO®-Tox HT platform and subsequent assay portfolio. Headcount is reported at 1–10 employees and revenue is not publicly disclosed.

Name

Hemogenix®

Legal name

Hemogenix, Inc.

Website

https://hemogenix.com

Company type

Private

Founded year

2000

Operating status

Operating

Headcount range

1–10 employees

Short description

Hemogenix® is a Colorado Springs-based contract research organization that provides proprietary ATP bioluminescence-based in vitro toxicity testing and cell biology services to biopharmaceutical companies, including more than half of the top 50 global biopharma firms.

Ownership category

akta.pro rank

Product category

Contract Research Services

NAICS

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

SIC

Services-Medical Laboratories (8071), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Hematology & Coagulation Laboratories (HLAFAMAC)

akta.pro secondary industries

Hematology Specialty Pharmaceuticals (Non-malignant) (HLAIACAI), Clinical Chemistry & Hematology Diagnostics (automated analyzers, blood testing) (HLAAALAH)

Keywords

• In vitro toxicity testing
• Contract research services
• Cell biology assays
• Drug safety screening
• Stem cell potency testing

Headquarters

HQ city

Colorado Springs

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, Supply Chain

Revenue model

1. Contract Research Services (CRO): HemoGenix® operates as a Contract Research Organization (CRO) providing fee-for-service in vitro toxicity testing and cell biology research services. Services are delivered through customized study contracts with biopharmaceutical companies, with study formats ranging from rapid toxicity screening reports to complete IND-enabling full-service studies with QA audit. Revenue is generated on a per-study basis with no recurring subscription model.

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels4 records

Core offering

Hemogenix® is a contract research organization that provides in vitro toxicity testing and cell biology research services to biopharmaceutical companies. The company uses proprietary ATP bioluminescence-based assay platforms built on Suspension Expansion Culture™ (SEC™) Technology to deliver high-throughput hematotoxicity, immunotoxicity, hepatotoxicity, cardiotoxicity, neurotoxicity, renal, skin, intestinal, and tumor cell toxicity testing, along with cell therapy quality and potency testing, IND-enabling studies, mechanism of action studies, and nanoparticle toxicity panels.

Product overview

Hemogenix® is a contract research organization specializing in in vitro toxicity testing and cell biology services. The company offers a comprehensive portfolio of proprietary ATP bioluminescence-based assay platforms, with HALO®-Tox HT as the foundational high-throughput hematotoxicity platform launched in 2002. The product ecosystem includes multiple tissue-specific toxicity testing platforms (ImmunoGlo™, MSCGlo™, HepatoGlo™, CardioGlo™, RenalGlo™, NeuroGlo™, SkinGlo™, EpiGlo™, CellaGlo™, STEMGlo™) that share the same standardized ATP bioluminescence readout technology, enabling direct comparison of drug toxicity across different tissues. The ComparaTOX™ Platform integrates all these assays for multi-tissue comparative toxicity screening in HT (high-throughput) and FS (full service) formats. Additional offerings include HemaToxFlow™ for flow cytometric analysis, potency assays (HALO® SC-IPS, MSCGlo™ SC-IPS, STEMGlo™ SC-IPS), quality control assays (STEMpredict™, HALO® QC), mechanism of action studies, nanoparticle toxicity testing, IND-enabling assay services, and in vivo to in vitro testing extensions. The sister company Preferred Cell Systems™ provides assay kits for in-house testing.

Differentiator

Problem solved

Functional benefit

Brands

• HALO®-Tox HT: Proprietary high-throughput hematotoxicity screening and testing platform using Suspension Expansion Culture™ (SEC™) Technology and ATP bioluminescence
• HemaToxFlow™
• ImmunoGlo™
• ImmunoGlo™-TCP
• ImmunoGlo™-BCP
• ImmunoGlo™-MLC
• MSCGlo™-Tox HT
• HepatoGlo™-Tox HT
• NeuroGlo™-Tox HT
• CardioGlo™-Tox HT
• RenalGlo™-Tox HT
• SkinGlo™-Tox HT
• EpiGlo™-Tox HT
• ComparaTOX™ Platform
• STEMGlo™-Tox HT
• CellaGlo™-Tox HT
• HALO® SC-IPS
• MSCGlo™ SC-IPS
• STEMpredict™
• HALO® QC
• HALO® TE
• HALO® PMT
• OxyFLOW™

Products and services

• HALO®-Tox HT Hematotoxicity Testing Proprietary high-throughput hematotoxicity screening and testing platform for stem and progenitor cell toxicity assessment, available in 96- and 384-well formats and validated according to FDA Bioanalytical Method Validation Guidelines.
• ImmunoGlo™ Immunotoxicity Testing ATP bioluminescence assay platform for immune cell proliferation, T-cell and B-cell specific cytotoxicity testing, and 1- or 2-way mixed lymphocyte reactions used for immunotoxicity screening and testing.
• HepatoGlo™-Tox HT Hepatotoxicity Testing Proprietary hepatotoxicity testing platform based on ATP bioluminescence readout for drug-induced liver toxicity (DILI) using various hepatocyte sources including iPS-derived and cryopreserved primary cells.
• CardioGlo™-Tox HT Cardiotoxicity Testing In vitro cardiotoxicity testing platform using ATP bioluminescence to measure cardiomyocyte viability, supporting multiple cardiomyocyte sources and species for high-throughput compound screening.
• NeuroGlo™-Tox HT Neurotoxicity Testing Proprietary neurotoxicity screening and testing platform using ATP bioluminescence with iPS-derived human neural cells including GABA neurons and motor neurons, available in 96- or 384-well formats.
• RenalGlo™-Tox HT Renal Toxicity Testing In vitro renal/nephrotoxicity testing platform using ATP bioluminescence with renal epithelial cell types from medulla, glomerulus, distal and proximal tubules, and cortex, supporting multiple species.
• SkinGlo™-Tox HT Skin Toxicity Testing In vitro skin toxicity testing platform using ATP bioluminescence with dermal fibroblasts and microvascular endothelial cells from multiple species.
• EpiGlo™-Tox HT Intestinal Toxicity Testing In vitro intestinal/gut toxicity testing platform using ATP bioluminescence for primary human intestinal cell populations including epithelial cells and myofibroblasts.
• MSCGlo™-Tox HT Mesenchymal Cell Toxicity Testing Standardized and validated ATP bioluminescence toxicity assay specifically designed for mesenchymal stem/stromal cells (MSCs), measuring functional viability based on intracellular ATP for toxicity testing and high-throughput screening.
• CellaGlo™-Tox HT Tumor Cell Testing In vitro testing platform for drugs affecting tumor cells using ATP bioluminescence technology.
• STEMGlo™-Tox HT Stem Cell Toxicity Testing In vitro toxicity testing platform for transformed cell lines, embryonic stem (ES) cells, and induced pluripotent stem (iPS) cells using ATP bioluminescence.
• ComparaTOX™ Multi-Tissue Comparative Toxicity Platform Multi-tissue comparative toxicity testing platform that integrates all Hemogenix ATP bioluminescence-based assays (HALO, ImmunoGlo, MSCGlo, HepatoGlo, CardioGlo, RenalGlo, NeuroGlo, SkinGlo, EpiGlo, CellaGlo, STEMGlo), enabling direct comparison of drug toxicity across different tissues and species. Available in HT and full-service formats.
• Cell Therapy Quality & Potency Testing Potency and quality testing service for hematopoietic and mesenchymal stem cells, including Identity, Purity, and Strength (SC-IPS) assays for cord blood, bone marrow, and mobilized peripheral blood; validated per FDA and EMA guidelines for regenerative medicine products.
• IND-Enabling Assay Services Contract research service providing standardized and validated assay results with measurement assurance parameters suitable for IND applications to the FDA. Results from Hemogenix studies have been included in numerous IND applications.
• Mechanism of Action Studies Comprehensive mechanism of action study services including flow cytometry, membrane integrity assays, micronucleus assay, soft agar assay, chemotaxis/migration assays, cytokine production/release, kinase/protease assays, mitochondrial dysfunction, oxidative stress assays, and CYP450 assays.
• Nanoparticle In Vitro Toxicity Panel Comprehensive nanoparticle toxicity testing panel providing alternatives to NCI Nanoparticle Characterization Laboratory (NCL) recommended assays, using superior primary human cells instead of animal cells or transformed cell lines.
• In Vivo to In Vitro Testing Service extending preclinical animal studies by preparing organs and tissues for in vitro culture systems to detect cellular responses not detectable by normal pharmacological tests, achieving approximately 80% concordance with in vivo results.
• HemaToxFlow™ Flow Cytometric Hematotoxicity Assay In vitro flow cytometric assay for determining potential hematotoxicity of stem and progenitor cells from human and mouse tissues, using CD markers to define specific differentiated cell populations as an alternative to colony-forming cell (CFC) assays.
• Contract Research Services (CRO) Full-service contract research organization offering customized full-service, rapid toxicity, and high-throughput screening study workflows covering hematotoxicity, immunotoxicity, hepatotoxicity, cardiotoxicity, neurotoxicity, renal toxicity, mesenchymal cell toxicity, intestinal toxicity, skin toxicity, tumor cell toxicity, and stem cell toxicity testing.

Quantifiable outcome

• 82% concordance between in vitro HALO®-Tox HT IC50 values and in vivo rat toxicity data
• +4 more outcomes

Named customers1 record

Segments1 record

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature14 records

Partnerships

Six partnerships are on record, tiered core, minor and moderate.

• Scientist.comcoreChannel Partner/ Reseller/ DistributorHemoGenix® is listed as a fully compliant Contract Research Service Supplier through Scientist.com, a major pharmaceutical outsourcing marketplace. Biopharmaceutical companies use Scientist.com to connect with HemoGenix® and receive quotes through the platform.
• Science ExchangeminorChannel Partner/ Reseller/ DistributorHemoGenix® contract research services are also available through the Science Exchange platform, providing additional channel access for clients seeking in vitro toxicity testing services.
• Preferred Cell Systems™coreStrategic or Co-development PartnerPreferred Cell Systems™ is a sister company of HemoGenix® that sells the same proprietary assay platforms as assay kits ('Assays-in-a-Box™') for customers who prefer to perform in-house testing. HemoGenix® and Preferred Cell Systems™ share the same proprietary ATP bioluminescence technology and assay platforms. Preferred Cell Systems™ helps customers establish assays in-house and also licenses the assays.
• Thermo Fisher Scientific (Service Marketplace)minorChannel Partner/ Reseller/ DistributorHemoGenix® is listed with 100% ratings on the Thermo Fisher Scientific Service Marketplace, which provides an additional platform channel for customers to discover and engage with HemoGenix® contract research services.
• National Cancer Institute (NCI) Nanoparticle Characterization LaboratorymoderateStrategic or Co-development PartnerThe NCI NCL established an assay cascade for testing nanoparticles used for clinical purposes. HemoGenix® provides superior alternative assays to many of the NCL-recommended assays, using primary human cells rather than animal cells or transformed cell lines. This represents a scientific validation and reference partnership.
• Promega CorporationmoderateTechnology or IntegrationHemoGenix® assay platforms use Promega products as signal detection reagents, including CellTiter-Glo® (ATP bioluminescence), GSH-Glo™ (glutathione assay), ROS-Glo™ (reactive oxygen species), Mitochondrial ToxGlo™, CaspaseGlo™, PDE-Glo™, Pgp-Glo™, and ADCC Reporter Bioassay. Promega's luciferase-based reagents form the detection backbone of all HemoGenix® proprietary assays.

Scale indicators9 records

Recent moves3 records

Expansion highlights6 records

Broad incumbents

• Labcorp Drug Development (Covance): One of the largest clinical and preclinical CROs with extensive in vitro toxicology and central lab services. Comparable as a full-service biopharma outsourcing partner, though many multiples larger than Hemogenix.
• Inotiv: Preclinical CRO and research models provider with toxicology and safety assessment services. Comparable as a specialized preclinical CRO serving drug development toxicology needs of biopharma.
• WuXi AppTec: Global CRO/CDMO providing preclinical toxicology and in vitro services for biopharma. Comparable in delivering outsourced toxicity testing services to biopharma sponsors across multiple geographies.
• Charles River Laboratories: Global preclinical CRO offering safety assessment, including in vitro toxicology and hematology studies. Comparable as a leading contract toxicology services provider to biopharma, though far broader in scope than Hemogenix's specialty in vitro hematotoxicity focus.
• Lonza Bioscience: Global CDMO and cell therapy services provider with bioassay and cell-based testing capabilities. Comparable in serving cell therapy developers with potency and quality assays, though at much greater scale.
• BioReliance (Merck KGaA): Biosafety, toxicology, and cell line characterization services within Merck's Life Science division. Comparable as a biopharma testing services provider, especially in cell-based safety and quality testing.
• Eurofins Scientific: Large bioanalytical and preclinical testing services provider serving pharma. Comparable in offering outsourced laboratory testing for drug development, including cell-based and bioanalytical assays.

Direct peers

• Cyprotex (Evotec): Specialty preclinical CRO focused on in vitro ADME and toxicity services including hepatotoxicity and cardiotoxicity. Closely comparable to Hemogenix as a specialist in vitro toxicology CRO using cell-based assays for biopharma.

Emerging players

• Stemcell Technologies: Supplies cell culture products, assays, and services supporting stem cell research and cell therapy development. Comparable in serving the hematopoietic and cell therapy research market with specialized assays and tools.

Others

• Cellular Dynamics International (Fujifilm): Supplies iPSC-derived cell types including iCell Hepatocytes used as input cells for Hemogenix's hepatotoxicity assays. Comparable as an enabler of in vitro toxicology testing through human-relevant cell models.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks5 records

Key highlights7 records

Customer concentration

• Xx.com/hemogenixinc
• Facebookfacebook.com/hemogenixco
• LinkedInlinkedin.com/company/hemogenix-inc

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Subsidiaries1 record

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 Hemogenix®