Aperio eIHCClinical Decision Support for ER/PR/HER2 Breast IHC

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AperioePathology Solutions

USA-IVD

Report Analysis Automated AutomatedImage Data Screen Interpretation Calculator Calculator

3. ReportGenerate customized PDF reports including tissue images, analysis data, and automatically-generated scores. You have full control over the final output, with manual score override.

1. ScanWhether your laboratory generates a high or low volume of slides, Aperio scanners offer crisp, clear images for analysis and viewing.

2. AnalyzeRun ER/PR/HER2 analysis in seconds, with fully automated algorithm settings.

Aperio CS2 – 5 slide compact footprint scanner.

Aperio AT Turbo – 400 slide high-throughput scanner.

Easily run an eIHC algorithm on a selected region or field of view.

Create your PDF report, ready to email or print.

Quickly analyze thousands of cells to provide quantitative and standardized IHC data.

Open slides in Aperio ImageScope to view and analyze.

Automatically save scoring data and mark-up in Aperio eSlide Manager.

*Aperio eIHC consists of a scanner (Aperio CS2 or Aperio AT Turbo), Aperio ImageScope viewer, and Aperio eIHC algorithms. Individual components of the Aperio eIHC system are not cleared for IVD use.

Fast, Data-Driven Support for Breast IHC Analysis–Aperio eIHCBehind every slide a patient is waiting. You want to provide the most accurate results for an informed treatment decision.

Aperio eIHC is a complete in vitro diagnostic solution*, offering reproducible and quantitative data to aid your review of ER, PR, and HER2 breast IHC.

Discover the three simple steps to powerful clinical decision support:

LeicaBiosystems.com

Copyright © 2017 Leica Biosystems Imaging, Inc. All Rights Reserved. LEICA and the Leica logo are registered trademarks of Leica Microsystems IR GmbH. Aperio is a trademark of the Leica Biosystems group of companies in the USA and optionally in other countries. Other logos, product and/or company names might be trademarks of their respective owners.

95.14658 Rev. A . IMC-1123-REV-A 5/2017LeicaBiosystems.com/AperioeIHC

Indications for Use:

The Aperio ePathology eIHC IVD System is an automated digital slide creation, management, viewing and analysis system. It is indicated for use as an aid in the management, prognosis, and prediction of therapy outcomes of breast cancer.

The IHC HER2 Image Analysis application is intended for use as an accessory to the Dako HercepTest™ to aid in the detection and semi-quantitative measurement of Her2/neu (c-erbB-2) in formalin-fixed, paraffin-embedded neoplastic tissue. When used with the Dako HercepTest™, it is indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN® (Trastuzumab) treatment is being considered.

The IHC ER Image Analysis application is intended for in vitro diagnostic use as an aid to the pathologist in the detection and quantitative measurement of ER (Estrogen Receptor) in formalin-fixed paraffin-embedded neoplastic tissue.

The IHC PR Image Analysis application is intended for in vitro diagnostic use as an aid to the pathologist in the detection and quantitation measurement of PR (Progesterone Receptor) in formalin-fixed, paraffin-embedded neoplastic tissue.

For full indications for use visit LeicaBiosystems.com.

eIHC1+eIHC 0 eIHC 2+ eIHC 3+

PR

Prog

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rone

Rec

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None Weak Moderate Intense

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ER

Estr

ogen

Rec

epto

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None Weak Moderate Intense

Area

of I

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est

Anal

ysis

Mas

k

HER

2

None Weak and partial Moderate and complete Intense and complete

Area

of I

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Anal

ysis

Mas

k