BioSpyder’s TempO-Seq Platform Supports FDA’s Expanding New Approach Methodologies Framework for Nonclinical Safety Assessment
BioSpyder, a leader in transcriptomic sequencing, highlights the role of its TempO-Seq® platform in supporting New Approach Methodologies (NAMs) for modern toxicology, drug development, and nonclinical safety assessment.
As regulatory agencies continue to advance strategies that reduce reliance on traditional animal testing, BioSpyder’s TempO-Seq platform provides researchers with a scalable transcriptomic approach for generating high-throughput gene expression data from in vitro and other biologically relevant model systems.
The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research has recently emphasized streamlined nonclinical study approaches and acceptable use of NAMs, including fit-for-purpose methods that may support weight-of-evidence assessments, mechanistic understanding, and improved human relevance in drug development. TempO-Seq aligns with this direction by enabling researchers to measure broad transcriptomic responses, characterize biological pathway activity, and generate data that can support toxicological interpretation across a range of experimental models.
TempO-Seq has also been applied in high-throughput transcriptomics programs led by the U.S. Environmental Protection Agency, where transcriptomic data are increasingly being used to evaluate chemical bioactivity, derive transcriptomic points of departure, and support next-generation approaches to chemical safety assessment. By combining scalable targeted RNA sequencing with flexible panel design and robust bioinformatics support, BioSpyder enables organizations to generate NAM-aligned transcriptomic data with greater speed, consistency, and cost efficiency.
BioSpyder provides a full-service workflow to support NAM-focused toxicogenomic studies, including sample processing, sequencing-ready library preparation, gene count tables, FASTQ files, service reports, and bioinformatics support services such as:
• Differential Gene Expression Analysis
• Pathway Analysis
• Machine Learning-Based Classification Analysis
• Transcriptomic Point-of-Departure Support
• Mechanistic and Toxicogenomic Interpretation
Garrett McComb, Director of Commercial Operations BioSpyder, commented, “As the regulatory landscape continues to move toward human-relevant, mechanism-based alternatives to traditional animal testing, TempO-Seq is well positioned to help researchers generate the transcriptomic evidence needed for modern safety assessment. Our platform provides a practical and scalable way to support NAM-based strategies across toxicology, drug development, and environmental health.”
BioSpyder remains committed to advancing transcriptomic technologies that support regulatory science, toxicogenomics, and the broader adoption of New Approach Methodologies. Through TempO-Seq, BioSpyder continues to help researchers generate high-quality molecular data that can inform safety assessment, chemical evaluation, and translational research.
For more information about FDA’s New Approach Methodologies initiative, visit: https://www.fda.gov/science-research/science-and-research-special-topics/new-approach-methodologies-nams
For more information about BioSpyder and TempO-Seq, visit: https://www.biospyder.com