Navigation Links
Leica Biosystems Receives FDA Approval for the Fully Automated Bond Oracle™ HER2 IHC System on the Leica BOND-MAX
Date:4/25/2012

NEWCASTLE UPON TYNE, England, April 25, 2012 /PRNewswire/ --

Leica Biosystems, a division of Leica Microsystems, announced that it has received Pre-Market Approval from the U.S. Food and Drug Administration for the Leica Bond Oracle HER2 IHC System (Product Code TA9147) with the Leica BOND-MAX, establishing their commitment to developing quality companion diagnostic products. The Leica Bond Oracle HER2 IHC System is a complete solution of ready-to-use reagents, HER2 control slides and Leica BOND-MAX instrumentation, designed to deliver increased diagnostic confidence and drive laboratory efficiency in HER2 IHC testing.

"The Leica Bond Oracle HER2 IHC System demonstrates high concordance to HER2 FISH," comments Arnd Kaldowski, President of Leica Biosystems. "The Leica Bond Oracle HER2 IHC System is validated as a fully-automated HER2 IHC test, and delivers the diagnostic confidence that comes with proven HER2 FISH concordance. With the Oracle system, laboratories also obtain the speed and efficiencies of Leica BOND-MAX instrumentation, delivering more effective workflow management."

The Leica Bond Oracle HER2 IHC System is intended for use on formalin-fixed, paraffin-embedded tissue, and can be used simultaneously with all other BOND protocols allowing unparalleled flexibility and workflow efficiency.

In clinical trials the Leica Bond Oracle HER2 IHC System achieved 2x2 concordance of 87.6% and a positive agreement of 93.8% with the Abbott Molecular PathVysion HER2 DNA Probe kit, considered the gold standard for assessment of HER2 status.

Full automation of HER2 IHC testing facilitates decreased process variation, increased protocol standardization and the delivery of consistent results. Confidence is further enhanced by the use of HER2 Control Slides demonstrating 0, 1+, 2+ and 3+ staining. "Use of the 2+ (equivocal) cell line, has the potential to improve assay performance, as this is a sensitive indicator of problems associate
'/>"/>

SOURCE Leica Microsystems
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. China Medical Technologies and Leica Microsystems Announce Collaboration
2. Evergreen Eye Center Introduces Groundbreaking Leica M22 Surgical Microscope for Cataract Surgery to the US
3. Incept BioSystems Initiates First Human Clinical Trial of its SMART Embryo Culture System for In Vitro Fertilization (IVF)
4. NEXUS Biosystems Acquires Tecan Groups REMP Sample Management Business
5. NEXUS Biosystems Completes Acquisition of REMP Sample Management Business From Tecan Group
6. Biosystems International Merges With Microbiochips
7. Incept BioSystems Completes First Human Clinical Trial of the SMART Start™ Embryo Culture System and Submits 510(k) Application to the FDA
8. Berg Biosystems and GNS Healthcare Announce Joint Venture - MAP Biosystems
9. Pancreas-targeted siRNA In Vivo Transfection Kit from Altogen Biosystems
10. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
11. Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/19/2014)... Sept. 19, 2014  Alere Inc. (NYSE: ... the following statement today in support of President ... "As the global leader in rapid diagnostics for ... national strategy to address the serious threat of antibiotic ... the Administration on initiatives to promote the development of ...
(Date:9/19/2014)... , Sept. 19, 2014  Lpath, Inc. (NASDAQ: ... bioactive lipid-targeted therapeutics, announced today that it has ... shares of common stock and 3,605,042 unregistered warrants ... price for one registered share of common stock ... share of common stock will be $3.475.  The ...
(Date:9/19/2014)... Fla. , Sept. 19, 2014  The body ... with the publication of two papers this past week.  ... – Head and Neck Surgery , finds that ... and subjective measures of sleep disordered breathing, leading the ... reduction in obstructive sleep apnea severity and improvement of ...
Breaking Medicine Technology:Alere Applauds President's Executive Order Combating Antibiotic-Resistant Bacteria 2Lpath, Inc. Announces $12.5 Million Registered Direct Offering 2Lpath, Inc. Announces $12.5 Million Registered Direct Offering 3New Data shows Reductions in obstructive sleep apnea (OSA) severity and improvement of quality of life with Inspire therapy 2New Data shows Reductions in obstructive sleep apnea (OSA) severity and improvement of quality of life with Inspire therapy 3New Data shows Reductions in obstructive sleep apnea (OSA) severity and improvement of quality of life with Inspire therapy 4
... 2 Medical Services,International Inc. (Pink Sheets: MSITF) is ... Fever Kit is increasing. Dengue Fever is,spreading across Latin ... in decades causing agonizing joint pain for hundreds of ... year. This year so far 630,356 cases have ...
... spans paleogenomics, paired-end mapping, and ... gene expression ... a Roche,company, is the subject of three ground-breaking studies published ... Sequencer(TM),system. The studies, entitled "Paired-End Mapping Reveals Extensive Genomic,Structural Variation ...
Cached Medicine Technology:Demand for VScan Dengue Fever Test Kits Increases 2Versatility of 454 Sequencing(TM) Demonstrated in Three Publications in Science Last Week 2Versatility of 454 Sequencing(TM) Demonstrated in Three Publications in Science Last Week 3Versatility of 454 Sequencing(TM) Demonstrated in Three Publications in Science Last Week 4
(Date:9/19/2014)... Rockville Centre, NY (PRWEB) September 19, 2014 ... 17, the manufacturers of the embattled blood-thinner Xarelto, named ... County Court of Common Pleas, have moved the court ... the cases do not have sufficient connection with Philadelphia.* ... & Development, et al. (No. 140304328; Pa. Comm. Pls., ...
(Date:9/19/2014)... (HealthDay News) -- U.S. military troops deployed to sunny ... according to a new study. Many returning ... In some cases, military personnel developed blisters on their ... or size of their moles since being deployed overseas. ... for skin cancer, the study authors noted. "The ...
(Date:9/19/2014)... 19, 2014 (HealthDay News) -- Pregnant women who live in ... low birth weight babies, a new study suggests. Researchers ... and found that expectant mothers who lived in a neighborhood ... 20 percent lower risk of very preterm birth (before 30 ... birth (30 to 36 weeks). Babies born to mothers ...
(Date:9/19/2014)... News) -- The U.S. Food and Drug Administration approved a ... part of a class of once-a-week injectable drugs that help ... "Trulicity is a new treatment option, which can ... control blood sugar levels in the overall management of type ... Office of Drug Evaluation II, said in an agency news ...
(Date:9/19/2014)... 2014 The Alliance for Bangladesh ... the National Fire Protection Association (NFPA), a recognized ... today in a Memorandum of Understanding signed by ... and other stakeholders with information, guidance and access ... health and safety of workers in ready-made garment ...
Breaking Medicine News(10 mins):Health News:Xarelto Makers Seek Dismissal of Cases Brought in Philadelphia, Notes Rottenstein Law Group LLP 2Health News:Xarelto Makers Seek Dismissal of Cases Brought in Philadelphia, Notes Rottenstein Law Group LLP 3Health News:Some U.S. Troops May Face Greater Skin Cancer Risk 2Health News:Do Greener Neighborhoods Produce Healthier Babies? 2Health News:FDA Approves Another Weekly Injectable Drug for Type 2 Diabetes 2Health News:Alliance for Bangladesh Worker Safety and NFPA Sign Memorandum of Understanding to Strengthen Safety in Bangladesh Garment Factories 2Health News:Alliance for Bangladesh Worker Safety and NFPA Sign Memorandum of Understanding to Strengthen Safety in Bangladesh Garment Factories 3
... of Nursing faculty member Rachel Jones has been selected ... for Community Engagement in Research. This award is for ... in part on data from Newark or Northern New ... Provosts Awards for Community Engagement to acknowledge the valuable ...
... For the first time, researchers have,identified structural ... The results of the study, conducted by ... in Charlottesville and The Children,s Hospital,of Philadelphia in ... the Radiological Society of North America (RSNA)., ...
... Can Learn activities help students identify their unique qualities ... while appreciating those ... All Kids Can, in,partnership with Scholastic, announced today the distribution ... inspire students,to discover their own special abilities and qualities and ...
... University of Pennsylvania School of Medicine and other study ... a non-invasive technique that excites neurons in the brain ... a safe and effective, non-drug treatment with minimal side ... other treatment options without benefit. , This ...
... Women who live in urban areas have denser breasts, ... to a study presented today at the annual meeting ... living in cities need to pay more attention to ... F.R.C.S., F.R.C.R., director of The London Breast Institute at ...
... New Haven, Conn. Bioengineers at Yale and Cornell ... and remains at the site of brain tumors ... according to a report in the November-December issue of ... increase treatment distances to more than a centimeter, which ...
Cached Medicine News:Health News:Rutgers College of Nursing faculty member Rachel Jones awarded Rutgers-Newark Provost Award 2Health News:Novel MRI Technique Shows Secondhand Smoke Damages Lungs 2Health News:Novel MRI Technique Shows Secondhand Smoke Damages Lungs 3Health News:'CVS Caremark All Kids Can' and Scholastic Distribute Free Educational Guides in Schools to Champion Acceptance and Build Self-Esteem among Second Graders 2Health News:'CVS Caremark All Kids Can' and Scholastic Distribute Free Educational Guides in Schools to Champion Acceptance and Build Self-Esteem among Second Graders 3Health News:Penn research shows transcranial magnetic stimulation effective in treating major depression 2Health News:City-dwelling women at greater risk for breast cancer 2Health News:New method of drug delivery more effective at reaching brain tumors 2
... believe that the trocar should be a ... precision and speeding the process. So we ... that meets the needs of the most ... - The only trocar that affords the ...
Operate with confidence. Autosuture is advancing the sate of both open and minimally invasive surgery by providing surgical tools that feel right, function right, and facilitate the right outcome eve...
... Many special order products are offered as ... long lengths. The modular instruments may be ... options such as ratchets, insulation and flush ... Mediflex stock. Customer specifications may affect delivery ...
Operate with confidence. Autosuture is advancing the sate of both open and minimally invasive surgery by providing surgical tools that feel right, function right, and facilitate the right outcome eve...
Medicine Products: