Stemina Biomarker Discovery has pioneered building human cellular models for toxicity screening of drug candidates, chemical compounds, and cosmetic and tobacco ingredients. Our in vitro toxicity assays offer an alternative to animal tests that are highly predictive of human response using human cell-based endpoints and very little test compound. These assays can provide data in only a few weeks at a fraction of the cost of animal testing.
“[Stemina] provides a key platform in support of EPA’s ToxCast and Virtual Tissue Model programs, including an assay on human embryonic stem cell metabolism that is highly unique … as they specialize in metabolomics profiling. [Stemina] consistently exceeded performance expectations and successfully delivered timely, high-quality, responsive services and products.”
Link to: devTox quickPredict
devTOX quickPredictTM is a biomarker-based, human, in vitro assay that predicts developmental toxicity. It utilizes key biomarkers identified using Stemina’s metabolomics platform.
Cardio quickPredictTM indicates the cardiotoxicity potential of drug candidates and other lead compounds based on changes in human induced pluripotent stem cell-derived cardiomyocyte (iPSC-CM) metabolism and viability.
Use of devTOX quickPredictTM as an Alternative Method Under the Revised ICH S5(R3) Guidelines
This informative webinar on the use of our assay devTOX quickPredictTM as an alternative method under the revised International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, “S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals,” is now available on YouTube.
This Stemina Webinar was presented by Jessica Palmer, M.S., the Associate Director of Toxicology. Her research interests are focused on the development and commercialization of in vitro models for predictive toxicology that utilize human pluripotent stem (hPS) cells and their derivatives combined with metabolomics-based biomarker identification. Ms. Palmer has over 15 years of experience in stem cell biology and application of pluripotent stem cells for toxicity testing. She is Editorial Board Member, Current Research in Toxicology, Elsevier publishing.
Stemina’s Cardio quickPredictTM Identifies Proposed COVID-19 Treatment as Cardiotoxic
As reported in Science, a chloroquine COVID-19 therapy trial in Brazil was halted over risk of fatal heart complications. US FDA has also issued cautions about chloroquine’s use as treatment for COVID-19. In our 2020 Toxicological Sciences publication, A Targeted Metabolomics-Based Assay Using Human Induced Pluripotent Stem Cell-Derived Cardiomyocytes Identifies Structural and Functional Cardiotoxicity Potential, we also identified chloroquine as having cardiotoxic effects. Cardio quickPredictTM accurately identifies chloroquine effects are:
- Prolonged QT and QRS
- AV blocks
- Cardiomyopathy
- Cardiac hypertrophy
Contact us today to talk with us confidentially about assaying your COVID drug targets and vaccine candidates for cardiotoxicity OR developmental toxicity.
The Results Are In!
Check out our recent publications….
Quantitative in vitro to in vivo extrapolation for developmental toxicity potency of valproic acid analogues [Birth Defects Research, May 2022]
microRNAs signatures as potential biomarkers of structural cardiotoxicity in human-induced pluripotent stem-cell derived cardiomyocytes [Organ Toxicity and Mechanisms, April 2022]
Use of human induced pluripotent stem cell-derived cardiomyocytes to predict the cardiotoxicity potential of Next Generation Nicotine Products [Frontiers in Toxicology, February 2022]
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 [Current Research in Toxicology, November 2020]
Watch Introduction to Stemina Video
Stemina Biomarker Discovery is one remarkable corporation with two distinct business units: Stemina is focused on toxicology, NeuroPointDX is focused on diagnosis and treatment of neurological disorders such as autism.
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We work with toxicologists to assess the safety of drug candidates, consumer products, and chemicals with our developmental toxicity assay and cardiotoxicity assay.
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Our new diagnostic test, the NeuroPoint Autism Spectrum Disorder (NPDX ASD) test, may lead to an earlier diagnosis for children with autism spectrum disorder.