Stemina Biomarker Discovery
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.
- Company typePrivate
- Founded2007
- HeadquartersMadison, United States
- Headcount11–50
- GTM typeB2B
- OfferingServices
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.
Stemina Biomarker Discovery firmographics
Firmographics- 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
Stemina Biomarker Discovery industry classification
Industry- Product category
- In vitro toxicity testing services
- NAICS
- Medical Laboratories (621511), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Medical and Diagnostic Laboratories (6215)
- SIC
- Services-Medical Laboratories (8071), Services-Commercial Physical & Biological Research (8731), In Vitro & In Vivo Diagnostic Substances (2835)
- akta.pro primary industry
- In Vitro Toxicology (Cell-based/Organ-on-chip) (HLAGAFAJ)
- akta.pro secondary industries
- Biomarker Discovery & Validation (omics, assay feasibility, clinical validation) (HLAAAMAA), Cell-Based & Potency Assays (Bioassays) (HLAGADAH), Genetic, Cytogenetic & Prenatal Screening IVD (HLAHAAAI)
Keywords
Where Stemina Biomarker Discovery is headquartered
LocationHeadquarters
- HQ city
- Madison
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Stemina Biomarker Discovery business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure
Revenue model
- 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.
- Custom Services: Custom metabolomics and toxicity screening services tailored to specific client needs for compound safety assessment.
- 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
Stemina Biomarker Discovery product offering
Product offeringCore 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
Companies that use Stemina Biomarker Discovery
Customer profileNamed customers7 records
Segments3 records
Ideal customer profiles4 records
Stemina Biomarker Discovery technology and API
TechnologyAPI detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
Stemina Biomarker Discovery partnerships and signals
Strategic signalPartnerships
Five partnerships are on record, tiered core and minor.
- U.S. Environmental Protection Agency (EPA)coreCollaboration 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. ArmycoreCollaboration on toxicity testing for military applications, including evaluation of toxic industrial chemicals (TICs) such as pesticides and their effects on human development.
- Ovid TherapeuticscorePartnership 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)coreMulti-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 CommerceminorCollaboration 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
Stemina Biomarker Discovery competitors and assessment
Company assessmentEmerging 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
Stemina Biomarker Discovery social profiles
Digital presenceStemina Biomarker Discovery financial estimates
Financial estimateRevenue estimate
Valuation estimate
Stemina Biomarker Discovery leadership team
Management profileNumber of profiles
Profiles6 records
Stemina Biomarker Discovery subsidiaries and ownership
Company hierarchySubsidiaries1 record
Stemina Biomarker Discovery funding detail
Funding detailFunding overview
Funding rounds9 records
Investors7 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Stemina Biomarker Discovery 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 Stemina Biomarker Discovery
What does Stemina Biomarker Discovery do?
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.
Is Stemina Biomarker Discovery a public or private company?
Stemina Biomarker Discovery is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Stemina Biomarker Discovery founded?
Stemina Biomarker Discovery was founded in 2007. It employs 11 to 50 people.
Where is Stemina Biomarker Discovery based?
Stemina Biomarker Discovery is headquartered in Madison, United States, in the North America region.
How does Stemina Biomarker Discovery make money?
Three revenue lines are on record. Contract Testing Services are the primary driver. The others are custom Services and diagnostic Products (NeuroPointDX).
Who are Stemina Biomarker Discovery's main competitors?
Emerging players on record are Axion Biosystems and StemoniX (acquired by Vyant Bio). Direct peers are Emulate, Toxys, Cyprotex (Evotec) and InSphero. Broad incumbents are BioIVT, Eurofins Discovery and Charles River Laboratories. Metabolon is listed as an others.
Does Stemina Biomarker Discovery have an API?
No public API is recorded for Stemina Biomarker Discovery.
What industry is Stemina Biomarker Discovery in?
Stemina Biomarker Discovery's product category is In vitro toxicity testing services. Its primary akta.pro industry code is HLAGAFAJ, In Vitro Toxicology (Cell-based/Organ-on-chip), with a secondary code of HLAAAMAA, Biomarker Discovery & Validation (omics, assay feasibility, clinical validation). Its NAICS code is 621511 and its SIC code is 8071.