HER2 CISH PharmDx Kit
by Dako Denmark A/S Denmark PMA
PMA P100024
Product code NYQ
Overview
The HER2 CISH PharmDx Kit is a chromogenic in situ hybridization (CISH) assay for nucleic acid amplification, designed to evaluate the HER2/NEU gene status in breast cancer. It employs dual-color chromogenic signals—red for HER2 and blue for the centromeric region of chromosome 17—to enable quantitative assessment of HER2 gene amplification in formalin-fixed, paraffin-embedded tissue sections under bright-field microscopy.
This kit is intended for use in pathology laboratories with automated processing via Dako Autostainer instruments. Supplied as a single-use diagnostic tool, it requires no additional regulatory approval beyond its FDA_PMA (P100024) designation. Results serve as an adjunct to clinical and pathologic data for guiding treatment decisions, particularly in stage II, node-positive breast cancer patients under consideration for trastuzumab (Herceptin) therapy.
Regulatory status
Withdrawn since 30 Nov 2011. The authorization below is no longer in force.
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPWD | NumberP100024 | Date30 Nov 2011 | StatusWithdrawn |
Coverage
- Withdrawn
- Not covered
United States — FDA PMA Withdrawn
Recalls
-
- Terminated Z-1093-2014
Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed.
Specification
- Generic Name
- Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer
- PMA Number
- FDA Product Code
- NYQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.1890
- Advisory Committee
- Pathology
- FDA Decision
- APWD Approval withdrawn
Other devices from Dako Denmark A/S
Questions
What types of breast cancer tissue samples can the HER2 CISH PharmDx Kit analyze, and how is the testing process automated?
The HER2 CISH PharmDx Kit is designed specifically for formalin-fixed, paraffin-embedded breast cancer tissue sections. The testing process is fully automated using Dako Autostainer instruments, which streamline the chromogenic in situ hybridization (CISH) procedure for detecting HER2/NEU gene status. This automation reduces manual handling and enhances consistency in signal detection (red for HER2, blue for chromosome 17) under bright-field microscopy.
Is the HER2 CISH PharmDx Kit intended for single-use only, and if so, how does this affect workflow in pathology labs?
Yes, the HER2 CISH PharmDx Kit is supplied as a single-use diagnostic tool, meaning each kit is intended for one analysis per tissue section. This design minimizes cross-contamination risks and ensures accurate, reproducible results. Pathology labs must account for this in their workflow by allocating one kit per patient sample, particularly when processing multiple cases simultaneously.
What clinical context is the HER2 CISH PharmDx Kit primarily used for, and how does it complement existing diagnostic tools?
The kit is primarily used as an adjunct to clinical and pathologic data to guide treatment decisions for stage II, node-positive breast cancer patients who may be candidates for trastuzumab (Herceptin) therapy. It provides quantitative assessment of HER2 gene amplification via dual-color signals, offering a complementary diagnostic approach alongside immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH) methods. Results aid in refining prognosis estimates beyond traditional clinicopathologic criteria.
How does the dual-color chromogenic signal system (red for HER2, blue for chromosome 17) improve accuracy in HER2 gene status evaluation?
The dual-color system allows pathologists to visually compare HER2 gene copy number (red signals) against the centromeric region of chromosome 17 (blue signals) on the same tissue section under bright-field microscopy. This direct, side-by-side visualization simplifies the quantitative assessment of gene amplification, reducing subjective interpretation errors common in single-probe assays. The clear distinction between signals enhances diagnostic confidence in determining HER2 status.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA PMA P100024