Red Thread Verge, part of the Red Thread solution, accelerates anti-drug antibody (ADA) assay workflows by automating the statistical analysis required to determine cut point, sensitivity, and low positive control (LPC).
Built on FDA and EMA immunogenicity guidance, Verge automates complex and often subjective manual calculations, reducing variability and delivering consistent, validated results in minutes.
Learn how Red Thread can help you
“I’ve been working with Red Thread for about a year now and their cut point tool [Verge] is incredibly easy and intuitive to use; no Stats degree required! As a CRO, calculating immunogenicity cut points require some flexibility to match client specific requests or adjustments based on the data. Red Thread quickly added key variables allowing us to use the software for most of our clients. Additionally, Red Thread, in combination with Watson LIMS, cut down on the duration to complete ADA validations by about one month. Draft statistical reports are now generated within 24 hours!”
Robert Kernstock, PhD, MBA
Former Director, ICON Bioanalytical Laboratories
Red Thread Verge Features & Functionalities for Immunogenicity Analysis
Cut Point
- Screening, Confirmatory, and Titer CPs
- Outlier removal or Random Effects Model approach
- Adjustable IQRs to fit the workflow
Sensitivity
- Screening and Confirmatory Sensitivity
- Calculated using linear, 4-PL, or 5-PL regression for both confirmatory and screening sensitivity
Low Positive Control (LPC)
- LPC determination for both screening and confirmatory sensitivity
- 99% upper confidence level using t-distribution
How Red Thread Verge Delivers Value Through Bioanalytical Automation
Validated. Compliant. Fast. Accurate.
By standardizing ADA data interpretation, Red Thread Verge enhances compliance, improves reproducibility, and supports faster decision-making in regulated and non-regulated bioanalytical environments.
34x
ROI
Through time and cost savings and achieving mandatory compliance, increased throughput, and reduced findings/warnings
97%
TIME SAVINGS
Time savings resulting from automation of data compilation and review can enhance turnaround times and improve resource management
79%
COST SAVINGS
Better allocate your human resources to critical, decision-making, and troubleshooting tasks
Objectivity + Consistency + Increased Throughput
Automation of manual, error-prone, bias-prone tasks brings consistency and results in improved resource allocation toward tasks that generate revenue
Key Resources for Cut Point Analysis
How does Red Thread work?
Red Thread follows a simple 3-step process and provides results within minutes to bioanalysts. For a more in-depth explanation, reach out to us to speak with one of our experienced analysts and see a demo of our product.
Contact us today and let us know what challenges you are facing.
Frequently Asked Questions about Red Thread Verge and Bioanalytical Automation
Does Red Thread Verge calculate immunogenicity cut points?
Yes, Red Thread Verge can calculate immunogenicity cut point, sensitivity, and low positive control (LPC) as part of its validated bioanalytical workflows. Red Thread Verge provides a validated, auditable workflow for cut point determination, statistical modeling with visualizations, and tables suitable for regulatory submission. Statistical report templates can be made available to further speed up the report writing process.
Is Red Thread Verge secure and/or validated?
Yes, Red Thread Verge is validated, and BioData can provide Operational Qualification / Performance Qualification for user validation. To ensure the security of your data, Red Thread is ISO 27001 certified and SOC 2 Type 2 attested. Red Thread complies with 21 CFR Part 11, CSV, GxP, FDA, and EMA regulations, and GDPR. The software provides access control, audit trails, data encryption, and numerous other features to ensure your data remains secure.
For further details, please visit our “Security and Compliance” page.
What are the input and output files required for Red Thread Verge?
The input file is directly exported from Watson (PK or Immunogenicity module) or simplified Excel tables from other sources, such as SoftMax Pro. The output file is a locked Excel file containing summary tables, reportable data tables, and visualizations (box plots, histograms, scatter plots, etc.) that are automatically generated in under 1 minute.
How can Red Thread Verge help with my ADA cut point data?
Red Thread Verge addresses significant challenges in bioanalytical workflows, notably the manual and subjective processes that often lead to long waiting times as bioanalysts first process data and then sometimes delayed further by short-staffed biostatistics teams. By automating key steps, standardizing workflows, and utilizing validated statistical modeling, Red Thread Verge reduces bias and minimizes reliance on manual intervention in bioanalysis, particularly for ADA assays, allowing a team to obtain a cut point and move forward with their process quickly. This comprehensive approach streamlines data analysis, accelerates turnaround, and supports more objective and reproducible results.
If I’m interested in Verge or other Red Thread modules, how can I get in touch?
Schedule a demo or connect with a Red Thread specialist to explore solutions tailored to your lab.
