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HEALTHCARE | Pharmaceuticals / Drugs

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Founded Year



Loan | Alive

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Last Raised

$680K | 2 yrs ago

About Stemina Biomarker Discovery

Stemina Cell Discovery discovers and validates small molecules as biomarkers for high-throughput drug screening and disease diagnostics using an all human system comprised of stem cells and the company's metabolomics platform. Metabolomics aims to enable the discovery of small molecules that can be used as candidate biomarkers of disease and pharmacological efficacy or toxicity. The human embryonic stem cell metabolome is a source of candidate biomarkers to predict, diagnose or measure the progress of disease or toxic response. Stemina aims to provide compound screening and diagnostic development for the pharmaceutical and biotechnology industries and academia under contract services or joint discovery agreements.

Stemina Biomarker Discovery Headquarter Location

504 South Rosa Road Suite 150

Madison, Wisconsin, 53719,

United States


Latest Stemina Biomarker Discovery News

Stemina’s Human Cell-Based devTOX quickPredict Assay Able to Predict Developmental Toxicity Potential of Nicotine-Containing Products

Dec 21, 2020

Stemina’s Human Cell-Based devTOX quickPredict Assay Able to Predict Developmental Toxicity Potential of Nicotine-Containing Products New research study published in the scientific journal Current Research in Toxicology Cell-Based devTOX quickPredict Assay predicts developmental toxicity. New research supports the utility of the devTOX quickPredict (devTOXqP) human induced pluripotent stem cell (iPS)-based assay from Stemina Biomarker Discovery (Stemina) as the first human-based in vitro assay to effectively predict risk to early embryonic development induced by chemical exposure, including that from nicotine-containing products. The new study, “The use of human induced pluripotent stem cells to screen for developmental toxicity potential indicates reduced potential for non-combusted products, when compared to cigarettes,” was published online this week in the journal Current Research in Toxicology by scientists from Stemina Biomarker Discovery, Inc. In this research, a variety of nicotine-containing products – including cigarettes, heated tobacco products, and tobacco-free electronic cigarettes (e-cigarettes) – were tested. Assay results predicted that aerosols from reference cigarettes and a heated tobacco product (HTP) trapped in phosphate buffered saline (PBS) offered significant potential risk for early developmental toxicity, driven largely by cytotoxicity from compounds other than nicotine, while those from a hybrid tobacco-flavored e-cigarette and non-tobacco containing e-cigarettes were not predicted to present the same risk in this assay. Stemina’s devTOXqP is a metabolomics biomarker-based test that assesses developmental toxicity potential based on the iPS cells’ alteration in the ratio of key biomarkers, ornithine and cystine (o/c). In this study, smoke and aerosol from test articles were bubbled into phosphate buffered saline (PBS). iPS cells were exposed to 8 concentrations of bubbled PBS (bPBS). Assay sensitivity was assessed through a spiking study with a known developmental toxicant all-trans24 retinoic acid (ATRA). Elizabeth Donley, JD, MBA, MS, Chief Executive Officer of Stemina, commented, “There is a serious need for rapid, cost-effective, high-throughput screening assays with greater relevance to humans than current animal-based tests. From a methodological standpoint, there is also growing regulatory interest in this specific endpoint, and new assays capable of evaluating developmental toxicity are required. The development and subsequent successful assessment of devTOX quickPredict against a variety of nicotine-containing products represents an important step in demonstrating proof-of-concept for this human-based test.” Until recently, assessing the potential toxicity of such products has required the use of in vivo animal testing. However, animal testing is costly, time-consuming, and often poorly predictive of toxicity in humans. Additionally, several European Union member states have banned the use of animal testing in assessing the relative toxicity of tobacco-related products. “While no single in vitro toxicology assay can cover the entire cycle of embryonic development, the results of this research suggest considerable value for devTOXqP as a rapid, cost-effective test for use in screening the potential toxicity of e-cigarettes and other non-combustible nicotine products,” commented Jessica Palmer, MS, Associate Director of Toxicology at Stemina and co-author on the study. The devTOXqP platform has been successfully used by the U.S. Environmental Protection Agency (EPA) to support their ToxCast and Virtual Tissue Model programs. As part of the EPA’s ToxCast Initiative, 1065 phase I and II compounds have been screened in the devTOXqP assay. Within the screened compounds, 19% were predicted to have the potential to cause developmental toxicity, and when compared to in vivo models, the assay had a 79% to 82% accuracy. Donley concluded, “As the greater use of in vitro assays based on human-derived cells is one of the aims of “Toxicity Testing in the 21st Century,” designed to lead to the reduced use or ultimate replacement of animal testing, we are working with the U.S. EPA and the U.S. Food and Drug Administration (FDA) to embed devTOXqP as a recommended assay in nicotine product safety evaluations.” Source: Company Press Release

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Expert Collections containing Stemina Biomarker Discovery

Expert Collections are analyst-curated lists that highlight the companies you need to know in the most important technology spaces.

Stemina Biomarker Discovery is included in 3 Expert Collections, including Regenerative Medicine.


Regenerative Medicine

1,818 items

Regenerative medicine refers to the process of activating, replacing, engineering or regenerating human genetic material, cells, tissues or organs to restore normal function. It also includes bioengineered tissues used for in vitro testing (e.g. organ-on-a-chip, organoids).



1,214 items

Companies involved in the capture, sequencing, and/or analysis of genomic, transcriptomic, proteomic, and/or metabolomic data


Biopharma Tech

820 items

Stemina Biomarker Discovery Patents

Stemina Biomarker Discovery has filed 12 patents.

The 3 most popular patent topics include:

  • Autism
  • Neurological disorders
  • Pervasive developmental disorders
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Related Topics




Developmental biology, Transcription factors, Biological databases, Rare diseases, Toxicology


Application Date


Grant Date



Related Topics

Developmental biology, Transcription factors, Biological databases, Rare diseases, Toxicology



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