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Boekel RapidFISH Slide Hybridizer

Boekel RapidFISH Slide Hybridizer

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Boekel RapidFISH Slide Hybridizer

Includes:
Boekel RapidFISH Slide Hybridizer, Slide Tray, and Metal Slide Holder

Features:
Self-clamping slide tray, ideal for hybridization
No coverslip glue necessary
Dual heater convection system for excellent temperature control
Process up to twenty (20) 3”x 1” glass microscope slides
Easy to use control system

Applications:
Histology, Pathology, FFPE sample storage, Cancer Research, Cancer Diagnosis, Genetic Research, Genetic Diagnosis

The Boekel RapidFISH Slide Hybridizer was designed to simplify Fluorescent In-Situ Hybridization (FISH) procedures for FFPE (formalin fixed paraffin embedded tissue) samples, cell suspensions, and other tissue preparation procedures. Temperature control and humidity are essential for FISH probes to bind to RNA and DNA. The RapidFISH has a self-clamping slide tray design that maintains the required humidity. Microscope slides in the Boekel RapidFISH Slide Hybridizer do not require coverslips to be glued because the removable tray of the slide incubator traps moisture in the system. Elimination of this step decreases processing time and ensures that the specimens stay hydrated during processing. The Boekel RapidFISH Slide Hybridizer has an easy to use control system for controlling temperature and time. The Boekel RapidFISH Slide Hybridizer has a small footprint and still maintains excellent temperature stability and uniformity because of its dual heater convection system. FISH testing is used worldwide to identify biological markers in the form of DNA/RNA.

Application Overview:

Molecular diagnostics is the fastest growing segment of the diagnostics market.  Fluorescent 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.

The Boekel RapidFISH Slide Hybridizer 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 700 million dollar 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

Microcentrifuge

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

Fluorescent microscope DAPI filter (blue), FITC filter (green), and Texas red filter capable of photography

 

The FISH Process (Simplified):

Sample prep – deparaffinization, 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, and place cover glass with cement.

Denature –  5 minutes at 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 (sensitive to light)

 

Crucial Process Steps:

Two steps in the FISH process require equipment such as the Boekel RapidFISH Slide Hybridizer for heating the slides; the denaturing step and the hybridization step.  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 FDA approved Tests

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.

 

Vysis D7S486/CEP 7 FISH Probe Kit

Abbott Molecular Inc.

K131508

Vysis EGR1 FISH Probe Kit

 

Abbott Molecular Inc.

K123951, K091960

B-cell chronic lymphocytic leukemia

Vysis CLL FISH Probe Kit

Vysis

K100015

Prosigna Breast Cancer Prognostic Gene Signature Assay

 

Nanostring Technologies

K130010

MammaPrint

 

Agendia, BV

K101454, K081092,K080252, K070675,K062694

INFORM HER2 Dual ISH DNA Probe Cocktail

 

Ventana Medical Systems, Inc.

P100027

HER2 CISH pharmDxTM Kit

 

Dako Denmark, A/S

P100024

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

P040005

 

BD Max MRSA Assay

BD Diagnostics (GeneOhm Sciences Canada, Inc.)

K120138

Staphylococcus QuickFISH BC

 

AdvanDx, Inc.

K113371

MRSA/SA ELITe MGB

 

EliTechGroup Epoch Biosciences.

K112937

Verigene Staphylococcus Blood Culture (BC-S) Nucleic Acid Test

 

Nanosphere, Inc.

K112424

NucliSENS EasyQ MRSA Assay

 

bioMerieux, Inc.

K102740

Xpert MRSA/SA Blood Culture Assay

 

Cepheid

K101879, K082140

Xpert MRSA/SA Nasal Complete Assay

 

Cepheid

K100822

LightCycler MRSA Advanced Test

 

Roche Molecular Systems, Inc

K091409

BD GeneOhm MRSA ACP Assay

 

BD Diagnostics (GeneOhm Sciences Canada, Inc.)

K093346

  1. aureus and/or other Staphylococcus species PNA FISH Culture

 

AdvanDx, Inc.

K092166

Xpert MRSA/SA SSTI Assay

Cepheid

K080837

 

BD GeneOhM StaphSR Assay

BD Diagnostics (GeneOhm Sciences Canada, Inc.)

K071026

  1. aureus PNA FISH

 

AdvanDx, Inc.

K091827, K060099

Xpert MRSA

Cepheid

K070462

IDI-MRSA Assay

 

Infection Diagnostic, Inc.

K042357, K033415

 

Adenovirus R-gene US

 

Argene, SA

K121942

ProAdeno+ Assay

 

Gen-Probe Prodesse, Inc.

K102952

Bacillus Anthracis

JBAIDS Anthrax Detection System

 

Idaho Technology, Inc.

K131930, K071188, K051713

Candida tropicalis

Candida albicans

Candida parapsilosis

Candida glabrata

Candida krusei

Affirm VPIII Microbial Identification Test

 

Microprobe Corp.

K931151, K931374

Yeast Traffic Light PNA FISH

 

AdvanDx, Inc.

K093024, K080719

Read more
Manufacturer

Boekel

Category

Miscellaneous

Model

240200

Dimensions (W x D x H)

11.00”w x 15.96”d x 8.09”h

Weight

21 lbs

Condition:

New

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