IQFISH pharmDx™ - Accurate and Non-toxic

FAST AND NON-TOXIC ASSAY WITH ACCURATE RESULTS

  • 1 hour hybridization, 3-and-a-half hours to results
  • Non-toxic solution means no need for fume hoods
  • Crisp and clear dual color signals make it faster and easier to identify gene status
  • An increased nuclear background staining helps visualize tissue morphology
  • No need for blocking or removal of repeat sequences
  • Simple and straightforward protocol
  • Optional batch pepsin treatment for high throughput and increased robustness


98.7% CONCORDANCE TO STANDARD FISH*

Specificity

No cross-hybridization to other chromosome targets or interference with closely related substances

 

Sensitivity

HER2/CEN-17 ratio between 0.97-1.08 in normal human breast epithelium

 

Reproducibility

Average coefficient of variation (CV) for observer-to-observer reproducibility of 3.2% for non-amplified specimens and 2.8% for amplified specimens. Lot-to-lot reproducibility of 5% for non-amplified specimens and 7.8% for amplified specimens

 

Robustness

Tested by varying type, time and temperature of the different steps in the assay. Robustness studies showed overall agreement with reference stain of 100%.

*Dako HER2 IQFISH pharmDx™ (Code K5731) has been compared with Dako HER2 FISH pharmDx™ Kit (Code K5331) in a comparative study. Cross tabulation of HER2 status obtained by the two assays gave an overall agreement of 98.7%. For more details, please refer to the current version of the package insert provided with the HER2 IQFISH pharmDx™ and TOP2A IQFISH pharmDx™ kits.

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