Inform Her2 DUAL ISH

2,921 views
2,736 views

Published on

What is it? The INFORM HER2 Dual ISH DNA Probe Cocktail is a laboratory test that uses DNA probes, with color-forming (chromogenic) dyes attached, to count how many copies of the HER2 gene, located on chromosome 17, are present in a tissue sample. This test, which uses a variation of fluorescence in situ hybridization (ISH), is based on color detection, rather than fluorescence, and is used with samples of tumor tissue removed from breast cancer patients. This test is used by a doctor (pathologist) trained to identify diseases by studying slices of cells and tissues placed on microscope slides. If the test result indicates that too many copies of the HER2 gene (gene amplification) are present in the cancer cell, then a breast cancer patient may be eligible for treatment with the anti-cancer drug Herceptin® (Trastuzumab).

Published in: Technology
0 Comments
1 Like
Statistics
Notes
  • Be the first to comment

No Downloads
Views
Total views
2,921
On SlideShare
0
From Embeds
0
Number of Embeds
7
Actions
Shares
0
Downloads
27
Comments
0
Likes
1
Embeds 0
No embeds

No notes for slide

Inform Her2 DUAL ISH

  1. 1. INFORM HER2 Dual ISH DNA Probe Cocktail assay Image Here 1
  2. 2. INFORM HER2 Dual ISH DNA Probe Cocktail assay INFORM HER2 Dual ISH is a fully automated assay for determining HER2 gene status in breast and gastric cancer tissue specimensFully Automated• Provides a rapid time to result and reduces resource requirements – ~12 hour run time – Baking Through Staining • Code, Load and GoEasily Interpreted Using Brightfield Microscopy• Allows for review of the entire tissue specimen and not just a selected area – See the HER2 gene status in the context of the tumour morphology – Ensure scoring of invasive carcinoma versus ductal carcinoma in situ – Identify tumour heterogeneity• Produces an archivable result – Staining results do not fade over timeRobust and Reproducible• Flexible protocol to address variations in preanalytical conditions• Highly concordant with FISH• Highly reproducible between laboratories and pathologists HER2 (black) and Chr17 (red) 60X 2
  3. 3. INFORM HER2 Dual ISH DNA Probe Cocktail assayOverview of the INFORM HER2 Dual ISH assay + cohybridisationIn the INFORM HER2 Dual ISH DNA Probe Cocktail assay the cocktail (A) of the DNP labeled HER2probe and DIG labeled Chr17 probe are cohybridised on the tissue sample. The HER2 gene is detectedby a dinitrophenyl (DNP) labeled probe (A) and visualised utilising ultraView Silver ISH DNP (SISH)detection (B). The Chromosome 17 centromere is targeted with a digoxigenin (DIG) labeled probe (A)and detected using ultraView Red ISH DIG detection (C). Dual ISH staining utilising this Dual Detectionresults in visualisation via light microscopy in which HER2 appears as discrete black signals (SISH) andChr17 as red signals (Red ISH). 3
  4. 4. INFORM HER2 Dual ISH DNA Probe Cocktail assay INFORM HER2 DUAL ISH DNA Probe CocktailIntended UseVentana Medical Systems (Ventana) INFORM HER2 Dual ISH DNA Probe Cocktail is designed to quantitatively detect amplification of the HER2 gene via two-color chromogenic ISH in formalin-fixed, paraffin-embedded human breast and gastric cancer, including the gastroesophageal junction, tissue specimens by light microscopyThe INFORM HER2 Dual ISH DNA Probe Cocktail is indicated as an aid in the assessment of patients for whom Herceptin® (trastuzumab) treatment is being consideredThis product should be interpreted by a qualified reader in conjunction with histological examination, relevant clinical information, and proper controlsThis reagent is intended for in vitro diagnostic (IVD) use 4
  5. 5. INFORM HER2 Dual ISH DNA Probe Cocktail assayThe INFORM HER2 Dual ISH is fully automated on all BenchMark series instruments Provides a rapid time to result and reduces resource requirements • ~12 hour run time Baking Through Staining • Code, Load and Go On all BenchMark series instruments • BenchMark GX system • BenchMark XT system • BenchMark ULTRA system BenchMark XT BenchMark ULTRA 5
  6. 6. INFORM HER2 Dual ISH DNA Probe Cocktail assay The INFORM HER2 Dual ISH is easily interpreted using brightfield microscopyBreast carcinoma with low level HER2 amplification Allows for review of the entire tissue specimen, not just a selected area – Use 20X, 40X or 60X objectives rather than 100X oil – See the HER2 gene status in the context of the tumour morphology – Ensure scoring of invasive carcinoma versus ductal carcinoma in situ – Identify tumour heterogeneity Produces an archivable result HER2 (black) and Chr17 (red) 60X – Staining results do not fade over time 6
  7. 7. INFORM HER2 Dual ISH DNA Probe Cocktail assayINFORM HER2 Dual ISH has a flexible protocol to address variations in preanalytical conditions• Recommended slide preparation – 10% neutral buffered formalin (NBF) for 6 to 48 hours – Embedded in paraffin – Sectioned at approximately 4 microns• To compensate for tissue variations, the assay has been designed with user selectable protocol steps to allow for optimization• <6% of slides may need to be restained• Recent studies suggest the majority of inconclusive HER2 gene assay results relate to pre-analytical factors – Under fixation – Over fixation – Delay to fixation – Fixative – Tissue thickness 7
  8. 8. INFORM HER2 Dual ISH DNA Probe Cocktail assay HER2 Dual ISH is highly concordant to Vysis PathVysion HER2 FISH on Breast• HER2 Dual ISH vs Vysis PathVysion HER-2 DNA Probe Kit FISH in breast tissue• First pass staining success rate – FISH 60% (80% after second attempt) – Dual ISH >93% 8
  9. 9. INFORM HER2 Dual ISH DNA Probe Cocktail assay HER2 Dual ISH is highly concordant to Dako HER2 FISH PharmDx on Gastric• HER2 Dual ISH vs Dako HER2 FISH PharmDx kit in gastric tissue 9
  10. 10. INFORM HER2 Dual ISH DNA Probe Cocktail assayINFORM HER2 Dual ISH can be combined with the Ventana fully automated IHC breast panel Ventana breast panel antibodies are all Rabbit Monoclonal • PATHWAY HER2 (4B5) • CONFIRM ER (SP1) • CONFIRM PR (1E2) •CONFIRM Ki-67 (30-9) 10
  11. 11. INFORM HER2 Dual ISH DNA Probe Cocktail assay Ventana the only provider of fully automated HER2 ISH and IHC solutions Patient Breast or Gastric Tissue Sample Pathway 4B5 INFORM HER2 DISH 0 1+ 2+ 3+ <2 ≥2Brightfield Negative Negative Reflex Positive Negative Positive INFORM HER2 DISH Report as HER2 positive to Oncologist for Herceptin <2 ≥2 Consideration Negative Positive 11
  12. 12. INFORM HER2 Dual ISH DNA Probe Cocktail assay INFORM HER2 Dual ISH is a fully automated assay for determining HER2 gene status in breast and gastric cancer tissue specimensFully Automated• Provides a rapid time to result and reduces resource requirements – ~12 hour run time – Baking Through Staining • Code, Load and GoEasily Interpreted Using Brightfield Microscopy• Allows for review of the entire tissue specimen and not just a selected area – See the HER2 gene status in the context of the tumour morphology – Ensure scoring of invasive carcinoma versus ductal carcinoma in situ – Identify tumour heterogeneity• Produces an archivable result – Staining results do not fade over timeRobust and Reproducible• Flexible protocol to address variations in preanalytical conditions• Highly concordant with FISH• Highly reproducible between laboratories and pathologists HER2 (black) and Chr17 (red) 60X 12

×