Category: Hybridization and UV Crosslinking
This Boekel Programmable Slide Moat includes 12-slide capacity, a friction hinged lid, a calibration mode and four leveling feet to accommodate any bench.
The Boekel Scientific programmable slide hybridization system offers researchers a compact 12 position Slide Hybridization system capable of performing complex IHC and InSitu Hybridization reactions. The digital microprocessor control offers full programmability of up to three time controlled temperature set points. The precision temperature control and sealed chamber offer the ideal environment for controlled IHC and InSitu Hybridization reactions. The Boekel Scientific Programmable Slide Hybridization system offers greater functionality with a compact footprint that compliments our complete line of Hybridization and Slide Hybridization systems.
Molecular diagnostics is the fastest growing segment of the diagnostics market. Flourescent In Situ Hybridization or FISH analysis comprises 700 Million of this 5 Billion dollar market. The FISH market is projected to grow at 11% year over year for the next five years. 400 to 500 million of this market is generated in the United States. FISH testing is used to identify biological markers in the form of DNA/ RNA. It is well-known method for genetic mapping and gene expression profiling. This technique uses fluorescent dye-labeled probes and a nucleotide sequence that is mapped to a chromosome or intra-nuclear DNA to generate a fluorescence signal which is visualized in situ by microscopy. It is performed on fresh preparations such as cytospins(cell suspensions) and touch preps or formalin-fixed, paraffin-embedded (FFPE) tissues may be used. It is used for research and clinical diagnostics in the areas of:
• Prenatal diagnosis
• Cancer diagnosis
• Molecular cytogenetic of birth defects and mental retardation
• Chromosomal abnormalities
• Clinical genetics
• Neuroscience
• Reproductive medicine
• Toxicology
• Microbial ecology
• Evolutionary biology
• Comparative genomics
• Cellular genomics
• Differentiation between benign and malignant tumors
The majority of this market is for reagents including FDA approved tests, companion diagnostics, research use only probes, custom probes and support reagents and supplies. There is a need for hybridization equipment to perform these labor intensive tests. To understand the need for hybridization equipment the process requirements must clearly be defined.
The equipment necessary is as follows:
- pH meter
- Balance
- Stir plate
- Micro-centrifuge
- Refrigerator
- Freezer
Tissue preparation will require:
- Microtome
- Water bath
- Oven
Performing the FISH procedure will require the following equipment and materials in addition to reagents:
- Slide dryer
- Water baths
- Hybridization Oven
- Coplin jars
- Coverslips
- Staining dishes
- Rubber cement (Optional: depends on equipment used)
- Fluorescent microscopes DAPI filter (blue), FITC filter (green), and a Texas red filter capable of photography
The FISH Process - Simplified
Sample prep – depariffinization, dehydrate, air dry, pretreatment(95C @ 30 min, Coplin Jar), protease treatment(37°C 10 – 20 min, Coplin jar), Dehydrate, Air Dry, Mark, apply fish probe,
Place Cover glass with cement
Denature - 5 minutes @ 75°C (45 – 50°C for metaphase spread + additional step to denature probe) Hybridization - 37°C 16hr – 72hr
Labeling Process
Direct Labeling – label is bound to the probe and it is less sensitive
- Or -
Indirect Labeling – Additional step before detection, probe detected using antibodies, results in amplified single
Storage – 4 – 8°C for up to two months, in dark area – light sensitive
Crucial Process Steps
Two steps in the FISH process require equipment for heating the slides; the denaturing step and the hybridization. These steps are similar for most FFPE FISH procedures.
Denature: Denaturing the probes and double stranded DNA
Average Time: 5 Minutes
Standard Temperature: 75°C
Hybridization: Hybridization of the probes to the target nucleic acids
Time Range: 16 – 72 Hours
Standard Temperature: 37°C
Developed slides must be stored at 4 – 8°C until they are evaluated under a microscope and photographed. They can be store for months at these temperatures.
List of Specific FISH Tests
There are thousands of FISH probes used for research supplied by dozens of companies. These do not have FDA approval. The FDA approved test that use the FISH procedure are listed below.
Herceptin (trastuzumab) |
BLA 103792 |
INFORM HER-2/NEU |
P940004S001 |
Ventana Medical Systems, Inc. |
The Inform Her-2/Neu gene detection system is a fluorescence in situ hybridization (FISH) DNA probe assay that determines the qualitative presence of Her-2/Neu gene amplification on formalin-fixed, paraffin embedded human breast tissue as an aid to stratify breast cancer patients according to risk for recurrence or disease-related death. It is indicated for use as an adjunct to existing clinical and pathologic information currently used as prognostic indicators in the risk stratification of breast cancer in patients who have had a priori invasive, localized breast carcinoma and who are lymph node-negative. |
Herceptin (trastuzumab) |
BLA 103792 |
PATHVYSION HER-2 DNA Probe Kit |
P980024S001-S012 |
Abbott Molecular Inc. |
The PathVysion HER-2 DNA Probe Kit (PathVysion Kit) is designed to detect amplification of the HER-2/neu gene via fluorescence in situ hybridization (FISH) in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Results from the PathVysion Kit are intended for use as an adjunct to existing clinical and pathologic information currently used as prognostic factors in stage II, node-positive breast cancer patients. The PathVysion Kit is further indicated as an aid to predict disease-free and overall survival in patients with stage II, node positive breast cancer treated with adjuvant cyclophosphamide, doxorubicin, and 5-fluorouracil (CAF) chemotherapy. The Pathvysion Kit is indicated as an aid in the assessment of patients for whom herceptin (trastuzumab) treatment is being considered (see herceptin package insert). |
Herceptin (trastuzumab) |
BLA 103792 |
PATHWAY ANTI-HER-2/NEU (4B5) Rabbit Monoclonal Primary Antibody |
P990081S001-S028 |
Ventana Medical Systems, Inc. |
Ventana Medical Systems’ PATHWAY Her2 (clone CB11) is a mouse monoclonal antibody intended for laboratory use for the semi-quantitative detection of c-erbB-2 antigen in sections of formalin-fixed, paraffin-embedded normal and neoplastic tissue on a Ventana automated immunohistochemistry slide staining device. |
Disease |
Trade Name |
Manufacturer |
Submission |
Acute Myeloid Leukemia |
Vysis D7S486/CEP 7 FISH Probe Kit |
Abbott Molecular Inc. |
|
|
Vysis EGR1 FISH Probe Kit |
Abbott Molecular Inc. |
|
B-cell chronic lymphocytic leukemia |
Vysis CLL FISH Probe Kit |
Vysis |
|
Prosigna Breast Cancer Prognostic Gene Signature Assay |
Nanostring Technologies |
|
|
MammaPrint |
Agendia BV |
|
|
INFORM HER2 Dual ISH DNA Probe Cocktail |
Ventana Medical Systems, Inc. |
|
|
HER2 CISH pharmDxTM Kit |
Dako Denmark A/S |
|
|
GeneSearch Breast Lymph Node (BLN) Test Kit |
Veridex, LLC. |
|
P060017 S001-S004 |
Dako TOP2A FISH PharmDx Kit |
Dako Denmark A/S |
|
P050045 S001-S004 |
DakoCytomation Her2 FISH pharmDx™ Kit |
DakoCytomation Denmark A/S |
|
|
BD Max MRSA Assay |
BD Diagnostics (GeneOhm Sciences Canada, Inc.) |
|
|
Staphylococcus QuickFISH BC |
AdvanDx, Inc. |
|
|
MRSA/SA ELITe MGB |
EliTechGroup Epoch Biosciences. |
|
|
Verigene Staphylococcus Blood Culture (BC-S) Nucleic Acid Test |
Nanosphere, Inc. |
|
|
NucliSENS EasyQ MRSA Assay |
bioMerieux, Inc. |
|
|
Xpert MRSA/SA Blood Culture Assay |
Cepheid |
|
|
Xpert MRSA/SA Nasal Complete Assay |
Cepheid |
|
|
LightCycler MRSA Advanced Test |
Roche Molecular Systems, Inc |
|
|
BD GeneOhm MRSA ACP Assay |
BD Diagnostics (GeneOhm Sciences Canada, Inc.) |
|
|
S. aureus and/or other Staphylococcus species PNA FISH Culture |
AdvanDx, Inc. |
|
|
Xpert MRSA/SA SSTI Assay |
Cepheid |
|
|
BD GeneOhM StaphSR Assay |
BD Diagnostics (GeneOhm Sciences Canada, Inc.) |
|
|
S. aureus PNA FISH |
AdvanDx, Inc. |
|
|
Xpert MRSA |
Cepheid |
|
|
IDI-MRSA Assay |
Infectio Diagnostic, Inc. |
|
Microorganism |
Trade Name |
Manufacturer |
Submission |
Adenovirus |
Adenovirus R-gene US |
Argene SA |
|
|
ProAdeno+ Assay |
Gen-Probe Prodesse, Inc. |
|
Bacillus Anthracis |
JBAIDS Anthrax Detection System |
Idaho Technology, Inc. |
|
Candida tropicalis / Candida albicans / Candida parapsilosis / Candida glabrata / Candida krusei |
Affirm VPIII Microbial Identification Test |
Microprobe Corp. |
|
|
Yeast Traffic Light PNA FISH |
AdvanDx, Inc. |
|
|
C. albicans / C. glabrata PNA FISH |
AdvanDx, Inc. |
|
|
C. albicans PNA FISH |
AdvanDx, Inc. |
|
|
C. Albicans screen |
Carr-Scarborough Microbiologicals, Inc. |
Entercoccus |
IMDx Van R for Abbott m2000 |
Intelligent Medical Devices, Inc. |
|
|
BD GeneOhm VanR Assay |
BD Diagnostics (GeneOhm Sciences, Inc.) |
|
|
Xpert vanA Assay |
Cepheid |
|
|
E. faecalis/OE PNA |
AdvanDx, Inc. |
|
|
GBS PNA FISH |
AdvanDx, Inc. |
|
|
E. faecalis PNA FISH culture identification kit |
AdvanDx, Inc. |
|
Enterovirus |
NucliSens EasyQ Enterovirus vl.1 Assay |
bioMérieux, Inc. |
|
Escherichia coli / Klebsiella pneumoniae / Pseudomonas aeroginosa |
GNR Traffic Light PNA FISH |
AdvanDx, Inc. |
|
|
E. coli/P. aeruginosa PNA FISH |
AdvanDx, Inc. |
|
|
EK/P aeruginosa PNA FISH |
AdvanDx, Inc. |
|
|
E. coli PNA FISH |
AdvanDx, Inc. |
|
Staphylococcus |
BD Max MRSA Assay |
BD Diagnostics (GeneOhm Sciences Canada, Inc.) |
|
|
Staphylococcus QuickFISH BC |
AdvanDx, Inc. |
Catalog Number: | 280001 (115V), 280001-2 (230V) |
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Overall Dimensions W x D x H: | 17'' x 10'' x 4'' |
Slide Capacity: | 12 slides |
Temperature Range: | Ambient +5°C to 99°C |
Stability: | Typically ± 0.2°C |
Heat Up Rate: | Ambient to 65°C in 20 minutes |
Shipping Dimensions W x D x H: | 22'' x 22'' x 12'' |
Shipping Weight: | 14 lbs |
Electrical: |
280001 (115V) 280001-2 (230V) |
Note: We strongly recommend using covered and sealed slides for higher temperatures (>37°C) or prolonged periods (> 1 hour) incubations. *230V units are supplied with continental European plug. |
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