Utilizing devTOXqP in a Combined Testing Approach for Identifying Developmental Toxicity Liability of Chemicals [Webinar Slides]
Aug 16, 2017Why develop devTOX? Reduce prevalence of birth defects and decrease animal testing. Our approach represents a unique opportunity to screen compound safety using a human endpoint. devTOX quickPredict is a predictive, targeted biomarker assay. (devTOX Discovery, on the other hand, is a predictive, untargeted metabolomics assay.) Jessica Palmer presented this webinar in October 2016. If
Toward Good Read-Across Practice (GRAP) Guidance
Aug 16, 2017Grouping of substances and utilizing read-across of data within those groups represents an important data gap filling technique for chemical safety assessments. Categories/analogue groups are typically developed based on structural similarity and, increasingly often, also on mechanistic (biological) similarity. While read-across can play a key role in complying with legislation such as the European REACH
Stem Cell-Based Methods for Identifying Developmental Toxicity Potential
Aug 16, 2017There is an increasing need for reliable, high-throughput in vitro developmental toxicity screens in both the pharmaceutical and chemical industries. Establishing predictive human cell-based assays to aid in the early discovery-phase detection of potential developmental toxicants is strongly warranted as these tests could reduce product development time and costs. Stemina authors include Jessica Palmer, Bob
A human induced pluripotent stem cell-based in vitro assay predicts developmental toxicity through a retinoic acid receptor-mediated pathway for a series of related retinoid analogues
Aug 16, 2017[Accepted manuscript] The relative developmental toxicity potency of a series of retinoid analogues was evaluated using a human induced pluripotent stem (iPS) cell assay that measures changes in the biomarkers ornithine and cystine. A human induced pluripotent stem cell-based in vitro assay predicts developmental toxicity …
Supporting Read-Across Using Biological Data
Aug 16, 2017Read-across, i.e., filling toxicological data gaps by relating to similar chemicals for which test data are available, is usually done based on chemical similarity. Besides structure and physico-chemical properties, biological similarity based on biological data adds extra strength to this process. In the simplest case, chemically similar substances also show similar test results in relevant
Presentation slides: Stemina participates in platform session at Teratology Society Annual Meeting
Jun 26, 2017Presented at the Teratology Society’s 57th Annual Meeting in Denver, Colorado in June 2017 by Stemina’s Associate Director of Toxicology, Jessica Palmer. Previous approaches for evaluating the accuracy of alternative test methods have been based on the classification of a chemical as either a positive or negative, with no other distinction. This method does not
Stemina’s Jessica Palmer to Present at Teratology Society Annual Meeting
Jun 14, 2017Jessica Palmer, Stemina’s Associate Director of Toxicology, will present at the Teratology Society’s 57th Annual Meeting, held June 24-28, 2017 in Denver. Anyone interested in developmental toxicity assays is encouraged to attend. Prediction of Developmental Toxicity Potential by In Vivo Exposures with a Biomarker-Based Human Pluripotent Stem Cell Assay This presentation is part of Platform
Human In Vitro Developmental Toxicity Assay Combined with a Read-Across Approach for Chemical Assessment
Mar 21, 2017Presented at FutureTox III: Bridges for Translation in Arlington, Virginia in November 2015 by Stemina’s Associated Director of Toxicology, Jessica Palmer. The reproductive and developmental toxicity requirements for registering chemical substances under REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) using whole-animal models could cost up to $8 billion and require the use of up
Comparative Retrospective Analysis of In Vivo and In Vitro Developmental Toxicity Predictions
Mar 14, 2017Presented at the Society of Toxicology’s Annual Meeting & ToxExpo in Baltimore, March 2017, by Stemina’s Associate Director of Toxicology, Jessica Palmer. Development and validation of in vitro models for developmental toxicity testing is essential for reducing the number of animals used toxicity testing. These assays have the potential to reduce or replace animal use in
Stemina to Present Sponsored Session, Poster at SOT’s Annual Meeting & ToxExpo 2017
Feb 20, 2017Stemina Biomarker Discovery will be well represented at the Society of Toxicology’s 56th Annual Meeting and ToxExpo. In addition to participating in SOT as an exhibitor (booth 2506), Stemina’s Jessica Palmer, Associate Director of Toxicology, will present new research in two sessions: Poster session: Monday, March 13th | 9:30 AM – 12:45 PM | P331
NeuroPointDX Partners with Ovid Therapeutics to Identify Biomarkers for Angelman Syndrome
Feb 9, 2017Together, Ovid and NeuroPointDX will use metabolomics data to better understand the rare neuro-genetic disorder known as Angelman Syndrome. NeuroPointDX’s metabolomics technology will be used in Ovid’s phase 2 STARS trial of its drug candidate, OV101.
Stemina Hosts Webinar: Exposure-Based Developmental Toxicity Prediction with the devTOX quickPredict Assay
Jan 18, 2017The required in vivo preclinical models for developmental toxicity testing have varying degrees of concordance with human effects, having approximately 70% concordance to known human developmental toxins. Development and validation of alternative methods for assessing developmental toxicity potential, such as the devTOX quickPredict assay (devTOXqP) would decrease the time, expense, and use of vertebrate animals.
Stemina Presenting Poster at ACT 37th Annual Meeting, November 6–9, 2016
Oct 14, 2016Jessica Palmer will present a poster entitled “Human Pluripotent Stem Cell-Based Assay Predicts Developmental Toxicity Potential of ToxCast Chemicals” at the annual meeting of the American College of Toxicology in Baltimore. Poster Abstract: Worldwide initiatives to screen for toxicity potential among the thousands of chemicals currently in use require inexpensive and high-throughput in vitro models to
Stemina to Present at Use of Cardiomyocytes for the Assessment of Proarrhythmic Risk Conference October 25-26
Oct 14, 2016Jessica Palmer will present a poster entitled “Development of a Biomarker-Based Cardiotoxicity Assay using Human Pluripotent Stem Cell-Derived Cardiomyocytes” at the upcoming Use of Cardiomyocytes for the Assessment of Proarrhythmic Risk Conference in Arlington, Virginia. Poster Abstract: Cardiac safety is one of the leading causes of late-stage compound attrition in the pharmaceutical industry and accounts for 28% of
Stemina CEO Beth Donley to deliver welcome remarks at 64th Annual Chamber Dinner
Sep 27, 2016Stemina’s CEO, Beth Donley, will deliver the welcome remarks at the 64th Annual Greater Madison Chamber of Commerce Dinner to be held September 28, 2016 at the Monona Terrace. Ms. Donley currently serves as the Board Chair. For more information, follow the link below: Read More
Stemina receives exceptional rating from EPA on devTOX assay performance
Jun 3, 2016Stemina is proud to announce that it has received an exceptional rating from the US Environmental Protection Agency for its work under ToxCast. Stemina’s devTOX assay is the only human developmental toxicity assay. Stemina offers its stem cell based assay in both human embryonic and induced pluripotent cell culture formats. Excerpt from the Contractor Performance
Stemina to Present Poster at IMFAR 2016
May 13, 2016The International Meeting for Autism Research (IMFAR) will be held in Baltimore, Maryland May 11-14. Visit the Saturday morning poster session to view our poster, “Evidence for Metabolomic Phenotypes Based on Analysis of Plasma from the APP Cohort.”
US EPA Presents devTOXqp Data
Mar 31, 2016Thomas Knudsen of the US EPA presented data on Stemina’s devTOXqp assay at the 2016 Society of Toxicology annual meeting.
Visit Stemina at SOT’s ToxExpo 2016
Mar 1, 2016Stemina will sponsor a session at the 2016 SOT Annual Meeting titled “Practical Application of a Human Stem Cell Assay for Developmental Toxicity Testing.” The session is Tuesday from 3:00 to 4:00 in Room 211. Stemina’s poster titled “Combination of a Human Pluripotent Stem Cell and Zebrafish Assay to Predict the Developmental Toxicity of Chemicals”
Autism Blood Test on Horizon
Feb 26, 2016A University of Wisconsin—Madison spinoff is screening blood samples in an effort to develop a biologically based method to diagnose autism through its diagnostic biomarker division, NeuroPointDX.
Donley Named InBusiness Exec of the Year
Feb 18, 2016Stemina’s CEO, Beth Donley, is named Executive of the Year by Madison’s InBusiness Magazine.
Stemina to receive National Institutes of Health grants
Sep 25, 2015Stemina Biomarker Discovery is getting two National Institutes of Health grants, one of which will let the Madison company start what it called the largest clinical study ever conducted into the metabolism of children with autism spectrum disorder (ASD).
Stemina Launches Large Autism Diagnostic Study
Sep 24, 2015With a new $2.7 million federal grant in hand, Stemina Biomarker Discovery has launched a 1,500-patient study of its experimental test to diagnose children with autism spectrum disorder. According to the company, it’s the largest clinical trial ever of this type of autism test—one that measures residues in the blood called metabolites.
Stemina Launches Autism Clinical Study
Sep 23, 2015Stemina Biomarker Discovery Inc. today announced the launch of the largest clinical study of the metabolism of children with autism spectrum disorder (ASD) ever conducted. The Children’s Autism Metabolome Project or “CAMP” study will enroll 1,500 subjects from six sites across the country. CAMP will attempt to confirm that sets of metabolic biomarkers can detect
Stemina Presents Poster with EPA at SOT
May 5, 2015Autism Speaks’s 2015 Autism Investment Conference (AIC2015) will take place on March 10-11, 2015 at the Seaport Hotel & World Trade Center in Boston, Massachusetts. The conference addresses the autism community’s most relevant and urgent needs. The program is structured into (8) individual sessions, each focusing on a different area of product or business development
Stemina to Present at IMFAR in Salt Lake City
Apr 14, 2015The International Meeting for Autism Research (IMFAR) is a scientific meeting to exchange and disseminate new scientific progress among ASD scientists and their trainees from around the world. Stemina’s Dr. Robert Burrier will be presenting his talk, “Effects of Metabolism Changes during Development on the Plasma Profile of ASD in Children” on Friday, May 15,
Beth Donley Interviewed by Xconomy
Nov 10, 2014In the latest attempt to find a better method for diagnosing autism, researchers at Madison, WI-based Stemina Biomarker Discovery and the University of California-Davis’ Mind Institute published study results Friday of an early-stage, blood-based test that they say identified autistic children with 81 percent accuracy.
Stemina Published in PLOS One
Nov 7, 2014Stemina Biomarker Discovery, Inc. today announced the publication of research conducted in collaboration with the MIND Institute at the University of California-Davis to identify biomarkers in the blood of children with autism spectrum disorders (ASD) that can distinguish them from typically developing children. The research is the first of its kind and has the potential
Stemina Receives Wisconsin Innovation Award
Aug 27, 2014Stemina was awarded a Wisconsin Innovation Award. About 120 nominations were received for the award. This was narrowed down to 10 award winners from around the state, featuring creative products and services from startups and large companies spanning biotech, software, manufacturing, and education.
Stemina to Present at WC9 Conference in Prague
Aug 25, 2014Stemina’s Beth Donley will present a poster titled “Toward Validation of a Human In Vitro Assay for Developmental Toxicity Assessment” at the 9th World Congress on Alternatives and Animal Use in the Life Sciences.
BrightStar Invests in Stemina
Mar 18, 2014Stemina Biomarker Discovery, is one of three Wisconsin businesses to win the first of the BrightStar Foundation’s investments.
EPA Awards Stemina $10M Contract
Jan 9, 2014Stemina Biomarker Discovery, Inc. announced that it has been awarded a contract by the United States Environmental Protection Agency under the EPA’s ToxCast initiative. The contract will generate up to $10,637,000 in revenue for Stemina over the next 5 years. Under the contract, Stemina will screen drugs and chemicals, using its devTOX toxicology tests, for
Beth Donley to present at International Conference on Environmental Mutagens
Nov 1, 2013Stemina’s Beth Donley will present at the 11th International Conference on Environmental Mutagens in Foz do Iguassu, Brazil on November 5. Her poster, “Establishment and assessment of a new embryonic stem cell based biomarker assay for developmental toxicity screening,” can be viewed here:
Laura Egnash to present at ACT San Antonio
Oct 22, 2013Stemina’s Laura Egnash will present at the 34th American College of Toxicology annual conference in San Antonio, Texas on November 4 and 5. Her poster, “Development of a Targeted Biomarker Assay to Predict Developmental Toxicity Using Induced Pluripotent Stem Cells,” can be viewed here:
Stemina Published in Birth Defects Research
Oct 11, 2013Stemina’s paper, “Establishment and Assessment of a New Human Embryonic Stem Cell-Based Biomarker Assay for Developmental Toxicity Screening” was published in Birth Defects Research.
Beth Donley to present at BIO Investor Forum
Oct 7, 2013Stemina CEO Beth Donley will be presenting at the 12th Annual BIO Investor Forum. Hosted by the Biotechnology Industry Organization (BIO), the 12th Annual BIO Investor Forum features leading private and emerging public companies. The meeting will take place October 8-9 at the Palace Hotel in San Francisco, California.
Alan Smith to present at Teratology Society Meeting
Jun 19, 2013Stemina’s Alan Smith will speak at the Teratology Society 53rd Annual Meeting in Tucson, Arizona. He will be presenting at the March of Dimes Symposium: Advances in the Genomic Sciences towards Public Understanding and Predicting Developmental Defects on Wednesday June 27th at 11:30 am.
Laura Egnash Presents at Agilent Users’ Meeting
Jun 8, 2013Stemina’s Laura Egnash presented at the Agilent Technologies users’ meeting at the 61st American Society of Mass Spectrometry annual conference. Her presentation, “Applying Metabolomics for Novel Biomarker Discovery and Commercial Assay Development,” can be viewed here:
Stemina Published in ALTEX
Apr 18, 2013Stemina’s Beth Donley co-authored a paper, Metabolomics in Toxicology and Preclinical Research, in ALTEX. ALTEX is the offical journal of CAAT (the Johns Hopkins Center for Alternatives to Animal Testing), EUSAAT (the European Society for Alternatives to Animal Testing), the Transatlantic Think Tank for Toxicology (Baltimore, Utrecht, Konstanz), and the Doerenkamp chairs in Germany, India,
Stemina to Sponsor Session at 2013 SOT Annual Meeting
Mar 6, 2013Stemina will sponsor a session at the 2013 SOT Annual Meeting titled “Human Embryonic Stem (hES) Cells for Predictive Toxicology.” The session is Wednesday from 10:30 to 11:30 in Room 007B. Stemina’s poster titled “A Metabolite-Based Biomarker Approach to Predict Developmental Toxicity Using Human Embryonic Stem Cells” will be on display Tuesday from 9:00 to
Stemina featured in InBusiness Magazine
Dec 7, 2012Stemina’s Beth Donley is featured in the December issue of InBusiness Magazine.
Stemina to Present Poster at ACT Annual Meeting
Nov 1, 2012Stemina is presenting its stem cell and metabolomics based developmental toxicity assay at the American College of Toxicology Annual Meeting in Orlando on November 5, 2012.
Stemina to Present at Eurotox 2012
May 7, 2012Stemina is presenting its stem cell and metabolomics based assays at EuroTox in Stockholm in the Agilent sponsored session on June 19, 2012.
Stemina and ILS to Exhibit at Annual Teratology Meeting
Apr 18, 2012Stemina and its North American partner, ILS, will exhibit at the 52nd annual meeting of the Teratology Society in Baltimore June 23-27.
Stemina awarded third Phase I SBIR
Feb 24, 2012Stemina was awarded its third Phase I SBIR today. The study, entitled “Identification of Biomarkers of Cardiotoxicity Using Metabolomics Analysis on Human Pluripotent Stem Cell-Derived Cardiomyocytes,” was funded by the National Institute of General Medical Sciences. The purpose of this study is to alleviate the financial burden of compound attrition due to cardiotoxicity and to
Stemina’s Paper Published in Toxicology and Applied Pharmacology
Nov 28, 2011Metabolomics analysis was performed on the supernatant of human embryonic stem (hES) cell cultures exposed to a blinded subset of 11 chemicals selected from the chemical library of EPA’s ToxCast™ chemical screening and prioritization research project. Metabolites from hES cultures were evaluated for known and novel signatures that may be indicative of developmental toxicity.
ILS and Stemina announce exclusive partnership for human stem cell based toxicology testing.
Nov 2, 2011ILS and Stemina Biomarker Discovery, Inc. announced today that the two companies have entered into a strategic partnership to advance Stemina’s stem cell based toxicology testing platform, beginning with devTOX. ILS will exclusively distribute Stemina’s platform in North America and the two companies will work jointly to further develop the platform.
CIT and Stemina Ink Deal in Europe
Nov 2, 2011Stemina announces the recent strategic partnership between Stemina and CIT in Evreux, France. Under this partnership, CIT will distribute Stemina’s assays in Europe leveraging CIT’s considerable reputation and expertise to bring Stemina’s cutting edge technology for predictive toxicology to the market.
Stemina Awarded Second Phase II SBIR
Feb 7, 2011Stemina received a 2 year contract to study biomarkers of teratogenicity and is a Phase II continuation of the original Phase I work performed for the National Science Foundation in 2010.
Stem cell scientists stress need for continued support of human embryonic stem cell research
Oct 26, 2010Concerned by election rhetoric that portrays adult stem cells as adequate substitutes for human embryonic stem cells, several leading scientists joined with a patient advocate and the founders of a growing biotechnology company Tuesday to set the record straight before voters head to the polls next week.
Stemina Receives $1 million Contract from NCI
Sep 30, 2010Stemina received a 2 year $1 million contract to study biomarkers of cancer stem cells and is a Phase II continuation of the original Phase I work performed for NCI in 2008 and 2009. This project will be conducted in collaboration with Mayo Clinic and the University of Wisconsin’s McArdle Cancer Center. Stemina will be
Stemina CEO Responds to Stem Cell Ruling and Wisconsin State Journal Article
Aug 25, 2010I wanted to take a minute to send you some accurate information about the facts as they relate to Stemina. Having worked on the legal and political aspects of this important technology since Dr. Thomson was the first to isolate hESC in 1998 at the University of Wisconsin while I served as General Counsel for
Stemina and Pioneer Hi-Bred Sign Research Agreement
Jun 1, 2010Under the collaboration, Stemina will use its proprietary metabolomics platform and expertise in discovery and validation of small molecules to identify biomarkers associated with specific plant traits.
Stemina Partners with Bristol-Myers Squibb
May 27, 2010A partnership with Bristol-Myers Squibb Co. will use Stemina’s products to evaluate whether drugs the New York pharmaceutical company is developing might be toxic to the heart.
Stemina Featured in GenomeWeb’s Startup Focus
May 27, 2010Leveraging one of the newer ‘omics fields along with stem cell technology, start-up firm Stemina Biomarker Discovery is looking to accelerate its work at developing metabolomic biomarkers for drug screening and efficacy and the detection of diseases.
Agilent Technologies Announces Collaboration with Stemina
May 24, 2010Agilent Technologies Inc. and Stemina Biomarker Discovery, Inc. today announced efforts to accelerate Stemina’s metobolomic research. Agilent is providing a 1290 Infinity UHPLC system to separate stem cellular metabolites, coupled to a 6530 Accurate Mass quadrupole time-of-flight mass spectrometer (Q-TOF MS) to identify those metabolites. Agilent also is providing Mass Profiler Professional software to help
Stemina Paper Accepted for Publication
May 5, 2010Toxicology and Applied Pharmacology accepted Stemina’s manuscript entitled “Predicting human developmental toxicity of pharmaceuticals using human embryonic stem cells and metabolomics” for publication. Read the abstract at the link below:
Stemina and California Stem Cell form Collaboration
Sep 17, 2009California Sem Cell and Stemina Biomarker Discovery announce their collaboration to validate effectiveness of human embryonic stem cell-derived cardiomyocyte progenitors for use in predictive toxicology.
Promega and Stemina Biomarker Discovery Collaborate to Improve Techniques in Stem Cell Research
Sep 16, 2009Promega Corporation, a provider of innovative solutions and technical support, and Stemina Biomarker Discovery, Inc. announced today that they have entered into a collaborative research agreement. The collaboration will combine Stemina’s expertise in human embryonic stem (hES) cells with Promega’s expertise in biological reagents and related instrumentation for use in studying cellular and functional biology.
Stemina Launches Its First Commercial Product
Apr 29, 2009Madison start-up Stemina Biomarker Discovery Inc. has launched its first commercial product, which uses human embryonic stem cells to screen drugs for their likelihood to cause birth defects. The launch comes shortly after President Barack Obama lifted restrictions on stem cell research, opening up opportunities for companies like Stemina, which also this month launched its
Inc. August 2008
Aug 6, 2008EVER SINCE THE economy started slowing last year, business owners have been complaining about a lack of access to capital. Not Elizabeth Donley. The CEO of Stemina Biomarker Discovery and her co-founder, Gabriela Cezar, raised $1.5 million from angel investors in six months after entering their Madison, Wisconsin-based stem-cell-research company in a business plan competition
Forbes June 2008
Jun 25, 2008Gabriela Cezar of biotech startup Stemina is unraveling the chemistry of autism. DRUG DISCOVERY IS A CRUAL BUSINESS. A hundred thousand people die every year because of adverse drug side effects. Millions die too young because drugs just aren’t good enough. The problem is that scientists invent medicines to treat people, but they have to
Wisconsin Woman June 2008
Jun 2, 2008When Gabriela Cezar and Beth Donley are together, there’s a certain electricity in the room. At once they are both excited and serious, moving rapidly and casually from fashion talk to a story about partying with celeb Ben Stiller to yet the more pressing work going on behind the closed doors of their UW Research