"Reproducibility study of HercepTest? mAb pharmDx on breast cancer specimens: Evaluation of between-day/run and between-laboratory reproducibility."
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- STATUS
- Not Recruiting
Summary
The study is a blinded reproducibility study of HercepTest mAb pharmDx on formalin-fixed and paraffin-embedded (FFPE) breast cancer tissue specimens, conducted at three individual testing laboratories. Each laboratory will perform five automated staining runs of sections from 40 breast cancer specimens on five non-consecutive days. The staining must be performed by one operator over a period of at least 20 days using reagents from one HercepTest mAb pharmDx device lot on one Dako Omnis instrument at each laboratory. One independent observer at each laboratory will evaluate the sections stained at the respective laboratory.
Description
The study is a blinded reproducibility study of HercepTest mAb pharmDx on formalin-fixed and paraffin-embedded (FFPE) breast cancer tissue specimens, conducted at three individual testing laboratories. Each laboratory will perform five automated staining runs of sections from 40 breast cancer specimens on five non-consecutive days. The staining must be performed by one operator over a period of at least 20 days using reagents from one HercepTest mAb pharmDx device lot on one Dako Omnis instrument at each laboratory. One independent observer at each laboratory will evaluate the sections stained at the respective laboratory.
Details
| Age | 100years or below |
|---|---|
| Clinical Study Identifier | TX9393 |
| Last Modified on | 19 February 2024 |
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