Webinar Overview:
Date: Wednesday, April 23rd, 2025
Time: 09:00 AM PT
Biomarker standardization is crucial for regulatory-compliant clinical trials and drug development. This webinar will explore how intelligent automation enhances biomarker data quality, streamlines regulatory submission, and improves patient outcomes.
Key Takeaways:
• Standardizing biomarker data for compliant submissions
• Automating cell phenotype characterization using marker expression
• Addressing standardization challenges in flow cytometry assays
• Developing a Metadata Repository for future-proof biomarker data
Get a free Demo from our team, mail us to: hello@pointcross.com
View Webinar Recording:
Learn more about: Standardization of Flow Cytometry Assay Data
Questions asked during webinar:
Could you describe how you work with the sponsor to receive the central lab data exports?
Does this mean that you work to define the data transfer specifications, or does it not matter what kind of export file is received?
There is no specific format required, as Xbiom’s Smart Transformer tool can support and accept various data formats. However, if the sponsor provides a specific Data Request Template (DRT), full automation can be achieved.
Could you describe what some of the conformance rules look like that PointCross has defined?
PointCross had defined 14 rules to validate the marker string from vendor and output generated from Xbiom tool. These rules validate the data is standardized as per CDISC definitions and data represented in line with CDISC guidelines
Here are a few examples:
Input marker validation: Checking marker expression consistency (markers with both positive and negative expressions).
Parent lineage checks: If subpopulation markers are reported without the parent lineage, it is not possible to recommend the cell type without additional input from the validation report or the scientific lead.
Paired variable rules: If one variable exists (like a Gate), its pair (e.g., Gate Definition) must exist too.
Data Representation checks: Depending on the measurement type (e.g., absolute, relative, or fluorescence), the test name and marker string should be represented accordingly
Do we have the ability to handle receptor occupancy assays?
Yes, the tool supports receptor occupancy assays as part of the CP domain. The webinar is focused more on Immunophenotyping category of data.
How does the tool standardize test names that are not defined in the CDISC standard?
CDISC terminologies are frequently updated, particularly with changes to submission values. Standardizing data using the Global registry enables seamless generation of CDISC outputs aligned to any specific version—without disruption. When new cell types not yet included in the CDISC Controlled Terminology are measured, the Global registry ensures continued standardization. These entries can later be managed as Extended Terms by peer review by Subject Matter Experts.
Do you handle results data only, or can standardization be managed at the metadata level too?
Standardization of markers can be achieved with metadata and when reported along with Subject results.
Is AI/ML used in the process of standardization?
Yes, the biomarker standardization process leverages machine learning techniques to predict the most likely lineage, as per the definitions of cell markers defined in Xbiom MDR, for a given marker string.
What are the other biomarker types supported by Xbiom tool for standardization?
Xbiom standardizes a wide range of biomarker data, including Genomics, IHC, ADA, and lab biomarkers.