Stemina Biomarker Discovery

What Stemina Biomarker Discovery does

Stemina Biomarker Discovery, Inc. is a privately held specialty biotechnology company founded in 2007 by Elizabeth Donley in Madison, Wisconsin. The company develops human cell-based in vitro toxicity assays that combine human embryonic stem (hES) cells and human induced pluripotent stem (iPS) cells with LC-MS metabolomics to predict developmental and cardiac toxicity of drug candidates, chemicals, cosmetic ingredients, and tobacco products. Its flagship product, devTOX quickPredict, measures the ornithine/cystine (O/C) biomarker ratio to predict teratogenicity and has been validated with 1,066 ToxCast chemicals in collaboration with the U.S. EPA. Cardio quickPredict extends the platform to cardiotoxicity screening using iPSC-derived cardiomyocytes.

The company operates two divisions: the Stemina toxicology services business, which offers contract testing, custom services, and the devTOX Discovery untargeted metabolomics assay, and the NeuroPointDX diagnostic business, which is commercializing the NPDX ASD blood test for autism spectrum disorder based on the Children's Autism Metabolome Project that enrolled more than 1,000 children across 8 sites. Revenue is generated through B2B enterprise contracts with pharmaceutical, agri-chemical, cosmetics, and tobacco companies as well as U.S. government agencies including the EPA and U.S. Army. Distribution is primarily direct sales via scientific conferences, the Society of Toxicology and American College of Toxicology events, and targeted engagement with toxicologists and regulatory scientists.

Stemina has raised approximately $16.4M across nine funding rounds from 2007 through 2017, with investors including BrightStar Wisconsin Foundation, Wisconsin Investment Partners, Phenomenelle Angels, DaneVest Capital, the National Institutes of Health, and the Madison Development Corporation. Key strategic milestones include ICH S5(R3) recognition of devTOX quickPredict as an alternative method, selection as the in vitro assay for the EU-ToxRisk case study on valproate analogues, and the 2017 board appointment of former Roche Molecular Diagnostics Head Heiner Dreismann to guide NeuroPointDX commercialization.

Name

Stemina Biomarker Discovery

Legal name

Stemina Biomarker Discovery, Inc.

Website

https://stemina.com

Company type

Private

Founded year

2007

Operating status

Operating

Headcount range

11–50 employees

Short description

Stemina Biomarker Discovery develops human stem cell-based in vitro toxicity assays using metabolomics to predict developmental and cardiac toxicity for pharmaceutical, chemical, cosmetics, and government clients, and operates a diagnostic division (NeuroPointDX) for autism spectrum disorder.

Ownership category

akta.pro rank

Headquarters

HQ city

Madison

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Contract Testing Services: Stemina provides toxicity screening services to pharmaceutical companies, chemical manufacturers, cosmetics companies, tobacco industry, and government agencies. Services include developmental toxicity testing using devTOX quickPredict and cardiotoxicity testing using Cardio quickPredict assays.
2. Custom Services: Custom metabolomics and toxicity screening services tailored to specific client needs for compound safety assessment.
3. Diagnostic Products (NeuroPointDX): NeuroPointDX division developing and commercializing diagnostic tests for autism spectrum disorder (ASD), including the NeuroPoint Autism Spectrum Disorder (NPDX ASD) test.

Go-to-market motion1 record

Distribution channels4 records

Marketing channels10 records

Core offering

Stemina Biomarker Discovery develops and commercializes human cell-based in vitro toxicity screening assays (devTOX quickPredict for developmental toxicity and Cardio quickPredict for cardiotoxicity) that combine human embryonic or induced pluripotent stem cells with LC-MS metabolomics to predict human teratogenicity and cardiotoxicity. The company sells these assays as contract testing services to pharmaceutical, chemical, cosmetics, tobacco, and government customers, and through its NeuroPointDX division is developing metabolite-based diagnostic tests such as the NPDX ASD test for autism spectrum disorder.

Product overview

Stemina Biomarker Discovery operates as a two-division company: Stemina (toxicology) and NeuroPointDX (neurodevelopmental diagnosis). The toxicology division offers devTOX quickPredict for developmental toxicity screening and Cardio quickPredict for cardiotoxicity assessment, both using human stem cell-based metabolomics assays. Custom Services provide additional tailored testing capabilities. The NeuroPointDX division is developing diagnostic products including the NPDX ASD test for autism spectrum disorder.

Differentiator

Problem solved

Functional benefit

Brands

• NeuroPointDX: Neurodevelopmental disorders division focused on diagnosis and treatment of neurological disorders such as autism spectrum disorder. Develops and commercializes diagnostic tests including the NeuroPoint Autism Spectrum Disorder (NPDX ASD) test.
• devTOX quickPredict
• Cardio quickPredict
• devTOX Discovery

Quantifiable outcome

• devTOX quickPredict identified chloroquine as cardiotoxic, including prolonged QT and QRS, AV blocks, cardiomyopathy, and cardiac hypertrophy effects
• +2 more outcomes

Named customers7 records

Segments3 records

Ideal customer profiles4 records

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Five partnerships are on record, tiered core and minor.

• U.S. Environmental Protection Agency (EPA)coreStrategic or Co-development PartnerCollaboration with EPA's ToxCast program for screening the ToxCast chemical library. Stemina's devTOX quickPredict assay is used to increase the diversity of in vitro assays used to assess developmental toxicity in the EPA's chemical safety evaluation programs. The partnership has generated data on 1,066 compounds.
• U.S. ArmycoreStrategic or Co-development PartnerCollaboration on toxicity testing for military applications, including evaluation of toxic industrial chemicals (TICs) such as pesticides and their effects on human development.
• Ovid TherapeuticscoreStrategic or Co-development PartnerPartnership to identify biomarkers of response in Ovid's clinical trial of a drug candidate to treat Angelman syndrome, a rare genetic disorder. This approach aims to enable more precise treatment through understanding patient metabolism and treatment response.
• Children's Autism Metabolome Project (CAMP)coreStrategic or Co-development PartnerMulti-site research study enrolling children 18-48 months old across 8 sites across the country. NeuroPointDX commercializes the diagnostic test developed from this research for autism spectrum disorder diagnosis.
• Greater Madison Chamber of CommerceminorOthersCollaboration on showcasing Stemina as an innovative Madison-area business in the 'Next Big Thing' series produced with Wisconsin State Journal.

Scale indicators3 records

Recent moves6 records

Expansion highlights5 records

Emerging players

• Axion Biosystems: Provides MEA-based in vitro cardiotoxicity and neurotoxicity assays using iPSC-derived cardiomyocytes and neurons. Comparable in offering human iPSC-CM-based cardiotoxicity screening services and instruments for drug safety testing.
• StemoniX (acquired by Vyant Bio): Developed iPSC-derived cardiomyocyte and neural platforms for in vitro cardiotoxicity and neurotoxicity screening. Comparable in providing human iPSC-based cardiotoxicity assays for early-stage drug safety assessment, with similar target customers.

Direct peers

• Emulate: Commercialises organ-on-chip platforms (Liver-Chip, etc.) for human-relevant in vitro toxicology and drug safety assessment. Closely comparable to Stemina as a cell-based in vitro toxicology platform targeting pharma and chemical industry safety testing.
• Toxys: Dutch-based specialty toxicology CRO offering in vitro assays (ToxTracker, ReproTracker) for genotoxicity and developmental toxicity screening. Directly comparable as a small, science-led in vitro toxicology services company targeting the same pharma/regulatory use cases.
• Cyprotex (Evotec): Evotec-owned preclinical CRO providing in vitro ADME and toxicology services, including cardiotoxicity and developmental toxicity screening for pharma. Directly comparable as a contract in vitro toxicology services provider.
• InSphero: Provides 3D microtissue (liver, pancreas, islet, tumor) in vitro assay services for toxicology and disease modelling. Comparable as a cell-based in vitro toxicology platform serving pharma safety testing needs.

Broad incumbents

• BioIVT: Supplier of biospecimens, in vitro test systems, and ADME/toxicology research services to pharma and consumer products companies. Comparable in providing human-cell-based in vitro testing services and reagents to the same enterprise buyer base.
• Eurofins Discovery: Large discovery and preclinical services CRO offering in vitro pharmacology, ADME, and safety pharmacology assays. Comparable in providing outsourced in vitro safety testing services to pharma and chemical companies, including cardiotoxicity and developmental toxicology endpoints.
• Charles River Laboratories: Global preclinical CRO offering a broad portfolio of in vitro and in vivo toxicology, safety assessment, and research services for pharma. Comparable as an in vitro toxicology services buyer/competitor at much larger scale, with overlapping cardiotoxicity and developmental toxicology offerings.

Others

• Metabolon: Commercial metabolomics services and biomarker discovery platform using mass spectrometry, similar in core LC-MS metabolomics technology to Stemina. Comparable as a metabolomics-based biomarker discovery service provider for pharma and clinical research applications.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/stemina_bio
• YouTubeyoutube.com/channel/UCOaMXX81CkJbQ199bJtWoEQ
• Facebookfacebook.com/SteminaBio
• LinkedInlinkedin.com/company/1234326

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Subsidiaries1 record

Funding overview

Funding rounds9 records

Investors7 records

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 Stemina Biomarker Discovery