Roche uPath IVD User manual

Brand: Roche

Model: uPath IVD

Type: User manual

Roche uPath IVD offers powerful capabilities for pathology laboratories. It enables comprehensive digital pathology workflows, from image acquisition and analysis to case management and reporting. With advanced image analysis algorithms, it assists pathologists in making accurate and efficient diagnoses. The system facilitates collaboration among pathologists, enabling remote consultations and second opinions. Additionally, uPath IVD complies with strict data security standards, ensuring the confidentiality and integrity of patient information.

uPath HER2 Dual ISH image analysis

for Breast Algorithm Guide

Table of Contents

Introduction 1

Algorithm Summary and Explanation 2

Clinical Signiﬁcance 3

Intended Use 4

Intended Use of product 4

Purpose of Algorithm Guide 4

Test Principles 5

Limitations 6

Data Security 7

Workﬂow for using the uPath HER2 Dual ISH

image analysis for Breast algorithm 8

Pathologist Workﬂow 10

Staining Characteristics 19

Performance Characteristics 31

Method Comparison 31

Pathologist Reproducibility Studies 32

Scanner Reproducibility Studies 33

Troubleshooting 34

References 38

Introduction

The Roche uPath enterprise software (uPath enterprise

software) with the uPath HER2 Dual ISH image analysis for

Breast algorithm is a software system designed to assist in

the quantitative assessment of HER2 gene status using two-

color chromogenic in situ hybridization (ISH) in formalin-ﬁxed,

parafﬁn-embedded (FFPE) normal and neoplastic tissues.

The uPath enterprise software is an end-to-end digital pathology

software solution that allows pathology laboratories to acquire,

manage, view, analyze, share, and report on digital images of

pathology specimens. Using the uPath enterprise software, the

pathologist can view digital images at various magniﬁcations,

add annotations, make tissue section measurements, perform

image analysis, and generate reports.

NOTE: The uPath HER2 Dual ISH image analysis for Breast

algorithm is an adjunctive computer-assisted methodology to aid

in the acquisition and measurement of images from microscope

slides of tissue specimens ISH-stained to determine HER2 gene

status. To assure the validity of image analysis scores, it is the

responsibility of the pathologist to verify agreement by employing

appropriate controls as speciﬁed in the VENTANA HER2 Dual

ISH DNA Probe Cocktail (VENTANA HER2 Dual ISH) method

sheet (available at www.ventana.com).

1 uPath HER2 Dual ISH image analysis for Breast Algorithm Guide

Algorithm Summary and Explanation

For image analysis applications, the pathologist may use the

uPath enterprise software to select and outline one or two (if

necessary) regions of interest (ROIs), using the Quick ROI tool.

Each ROI may be viewed at various magniﬁcations and then

analyzed by the uPath HER2 Dual ISH image analysis for Breast

algorithm. The Heatmap guides pathologists to the areas

the algorithm has identiﬁed as having high ampliﬁcation of

HER2 signals.

When the pathologist draws an ROI using the Quick ROI tool

(Quick ROI must be used to run analysis) the uPath HER2

Dual ISH image analysis for Breast algorithm ﬁrst identiﬁes

20 representative tumor cells. Cells are ranked based on: cell

size, presence of at least one HER2 and one Ch17 signal and

segmentation conﬁdence. The total number of HER2 and Chr17

signals for the 20 representative tumor cells is computed.

Through the quantiﬁcation of HER2 and Chr17 signals the uPath

HER2 Dual ISH image analysis for Breast algorithm generates a

HER2/Ch17 ratio. The pathologist can accept the cells selected

and the score provided by the uPath Dual ISH image analysis for

Breast algorithm, or may manually replace cells and override the

score with a different score. The pathologist can also delete the

initial ROI and replace it with a new ROI on a more suitable region

of tissue.

The uPath HER2 Dual ISH image analysis for Breast algorithm

makes no independent interpretations of the data and therefore

should only be used by a qualiﬁed pathologist in conjunction with

histological examination, relevant clinical information and proper

controls. It is designed and indicated as an aid to the pathologist

for the assessment of HER2 gene status.

2 uPath HER2 Dual ISH image analysis for Breast Algorithm Guide

Clinical Signiﬁcance

Breast cancer is the most common carcinoma occurring in

women, and the second leading cause of cancer related death.

Overall prognosis can be signiﬁcantly improved with early

detection and appropriate treatment therapies.

While protein

expression varies by breast carcinoma subtype, c-erbB-2

oncoprotein (HER2) is an important marker in breast cancer.

HER2 is a transmembrane protein present in the cellular

membrane. It is expressed in breast carcinomas at differing

levels and with different patterns of expression.

Being closely related to EGFR, it has tyrosine kinase activity

suggesting it may be involved in signal transduction and

stimulation of mutagenic activity.

The HER2 gene, located on

Chr17 in humans, encodes the HER2 protein. Overexpression of

the HER2 protein, ampliﬁcation of the HER2 gene, or both, occur

in approximately 15 to 25 percent of breast cancers and are

associated with aggressive tumor behavior.

3-7

In situ hybridization can be used to detect ampliﬁcation of

the HER2 gene in invasive breast carcinoma, making it an

effective tool for pathologists in their diagnosis and prognosis of

carcinomas. The VENTANA HER2 Dual ISH assay is intended for

laboratory use for the quantitative detection and enumeration of

the HER2 gene in sections of formalin-ﬁxed, parafﬁn-embedded

normal and neoplastic tissue. An advantage of histological tissue

preparations is that intact tissue allows morphology to aid in the

interpretation of the HER2 positivity of the patient sample. All

histological tests should be interpreted by a specialist in breast

cancer morphology, and/or pathology. The results should be

complemented by morphological studies, proper controls and

used in conjunction with other clinical and laboratory data.

3 uPath HER2 Dual ISH image analysis for Breast Algorithm Guide

Intended Use of product

The uPath HER2 Dual ISH image analysis for Breast algorithm

is intended for use as an aid to the pathologist to determine

HER2 gene status by enumeration of the ratio of the HER2

gene to Chromosome 17, in formalin-ﬁxed, parafﬁn-embedded

neoplastic breast tissue specimens. When used with the

VENTANA HER2 Dual ISH Assay, it is indicated as an aid in the

assessment of breast cancer patients for whom Herceptin

(trastuzumab) treatment is being considered.

Note: The uPath HER2 Dual ISH image analysis for Breast

algorithm is an adjunctive computer-assisted methodology to aid

in the acquisition and measurement of images from microscope

glass slides of tissue specimens that have undergone color

chromogenic in situ hybridization (ISH) to determine HER2 gene

status. To assure the validity of Image Analysis scores, it is the

responsibility of the pathologist to verify agreement by employing

appropriate controls as speciﬁed in the VENTANA HER2 Dual

ISH Assay method sheet (PN 1018383EN).

This algorithm is intended for in vitro diagnostic (IVD) use.

Intended Use

Purpose of Algorithm Guide

This uPath HER2 Dual ISH image analysis for Breast algorithm

Guide (Algorithm Guide) is intended to:

• Provide background information on the intended use of the

uPath HER2 Dual ISH image analysis for Breast algorithm,

test principles and limitations.

• Deﬁne the necessary materials, IT, data security and

network requirements.

• Show step-wise directions for running the uPath HER2 Dual ISH

image analysis for Breast algorithm.

• Provide photographic images that illustrate how the uPath HER2

Dual ISH image analysis for Breast algorithm should be used.

• Provide pathologists with a tool to facilitate the use of the

uPath HER2 Dual ISH image analysis for Breast algorithm on

FFPE breast sections stained with the VENTANA HER2 Dual

ISH assay.

• Provide example images of challenging cases to provide

guidance on how to use the uPath HER2 Dual ISH image

analysis for Breast algorithm in their evaluation.

• Show performance characteristics of the uPath HER2 Dual ISH

image analysis for Breast algorithm.

4 uPath HER2 Dual ISH image analysis for Breast Algorithm Guide

Test Principles

Quantitative Scoring Algorithm for the VENTANA HER2 Dual

ISH assay:

The VENTANA HER2 Dual ISH DNA assay uses quantitative

scoring algorithm to determine the HER2/Chr17 ratio. The

uPath HER2 Dual ISH image analysis for Breast algorithm was

designed to adhere to the VENTANA HER2 Dual ISH assay

scoring algorithm (provided below) and workﬂow detailed in

the VENTANA HER2 Dual ISH assay method sheet.

The uPath enterprise software with the uPath HER2 Dual ISH

image analysis for Breast algorithm employs image analysis

techniques to obtain a HER2 gene status.

The uPath HER2 Dual ISH image analysis for Breast algorithm

uses pre-deﬁned parameters to score images of tissue stained

with the VENTANA HER2 Dual ISH assay.

Steps involved in image analysis:

• Detection of cells across the entire image.

• Identiﬁcation of scorable cells and selection of 20 representative

tumor cells based on: cell size, number of red

and black signals and segmentation conﬁdence.

• Computation of the HER gene status by dividing the total

number of HER2 signals by the total number of Chr17 signals

according to the VENTANA HER2 Dual ISH assay method sheet.

How uPath HER2 Dual ISH image analysis for Breast

algorithm identiﬁes tumor cells and how the score

is calculated:

• The uPath HER2 Dual ISH image analysis for Breast

algorithm identiﬁes tumor cells using color, intensity,

size and morphological features.

• Identiﬁed tumor cells are stratiﬁed using pre-set thresholds

that are in line with the VENTANA HER2 Dual ISH assay

method sheet.

• To calculate the HER2 gene status, the uPath HER2 Dual ISH

image analysis for Breast algorithm quantiﬁes the identiﬁed

HER2 (black) and Chr 17 (Red) signals and generates a HER2/

Chr17 ratio according to the VENTANA HER2 Dual ISH assay

method sheet.

Calculate HER2/Chr17 ratio by dividing

the total number of HER2 signals

from Target Area 1 by total number

of Ch17 signals from Target Area 1

Count HER2 and Chr17

signals in 20 nuclei

Identify and select target area

Count additional

20 nuclei

Report Results

Non-Ampliﬁed

HER2/Chr17<2.0

Ampliﬁed

HER2/Chr17 ≥ 2.0

Calculate HER2/Chr17 ratio by

dividing the total number of

HER2 signals from Target

Areas 1 and 2 by the total

number of Chr17 signals

from Target Areas 1 and 2

Inadequate

Start

HER2/Chr17

stained slide

Slide

adequate?

Is HER2/Chr17

1.8-2.2?

Yes

5 uPath HER2 Dual ISH image analysis for Breast Algorithm Guide

The uPath HER2 Dual ISH image analysis for Breast algorithm is

designed to work for the VENTANA HER2 Dual assay. The test

results are only as good as the quality and accuracy of the ISH

slide that is imaged, and the subsequent image that is analyzed.

The pathologist must validate the VENTANA HER2 Dual ISH

assay staining by examining the slide on the uPath enterprise

software and using internal controls to verify that the expected

results have been obtained before images of slides are analyzed.

Use the manufacturer’s recommendations for the VENTANA HER2

Dual ISH assay including using all positive and negative quality

control materials for each staining run. If the internal controls is not

acceptable, restain the tissue with acceptable results.

The pathologist must follow the recommendations for VENTANA

HER2 Dual ISH assay interpretation.

Refer to the VENTANA HER2 Dual ISH assay method sheet

(P/N 1018383EN ) and interpretation guide (P/N 1018386EN)

(available at www.ventana.com).

The uPath HER2 Dual ISH image analysis for Breast algorithm

is designed to be used by a qualiﬁed pathologist in conjunction

with histological examination, relevant clinical information and

proper controls. It is not designed to be a standalone tool,

and requires competent human intervention throughout the

analysis process.

The uPath HER2 Dual ISH image analysis for Breast algorithm

may generate incorrect scores if the captured images have:

abnormal staining (non-target staining, overstaining of counter

stain, etc.)

The uPath HER2 Dual ISH image analysis for Breast algorithm

may reject tumor nuclei that are elongated regardless of the

overall shape of the cell. For this reason, tumors containing large

numbers of cells with elongated tumor nuclei may need to be

evaluated manually.

The uPath HER2 Dual ISH image analysis for Breast algorithm

has been trained, developed, and validated on invasive

carcinoma tissue samples.

The uPath HER2 Dual ISH image analysis for Breast algorithm

has not been tested, or its safety and effectiveness validated,

when used with a personal computer (PC) from home.

The uPath HER2 Dual ISH image analysis for Breast algorithm

may mischaracterize lymphocytes as a tumor cell. The

pathologist should visually inspect the tissue carefully and,

if possible, avoid regions of tissue where immune cells

compose more than 30% of all cells.

The uPath HER2 Dual ISH image analysis for breast algorithm

is indicated for use as an aid in identifying patients for treatment

with Herceptin based on HER2 gene ampliﬁcation in accordance

with the approved therapeutic product labeling.

Limitations

6 uPath HER2 Dual ISH image analysis for Breast Algorithm Guide

Malicious software or unauthorized instrument access can

result in data loss or instrument unavailability.

To avoid infection by malicious software or unauthorized access

and misuse of the instrument, the following recommendations

are essential:

• Do not install or run any other software on the instrument.

• Make sure that other computers and services on the network

are properly secured and protected against malicious software

and unauthorized access. For example, the laboratory

information system (LIS), archiving share, backup share,

or service.

• Customers are responsible for the security of their local area

network, especially in protecting it against malicious software

and attacks. This protection might include measures, such as

a ﬁrewall, to separate the device from uncontrolled networks.

This protection might also include measures that ensure that

the connected network is free of malicious code.

• Restrict physical access to the instrument and all attached

IT infrastructure (computers, cables, network equipment,

and so on).

• Make sure that instrument backup and archive ﬁles are

protected from any unauthorized access and disaster. This

list includes the remote storage location, disaster discovery

sites, and the secure transfer of backup ﬁles.

• If possible, use a ﬁrewall to restrict network trafﬁc.

• USB ﬂash drives can be used for several kinds of backups

and restores. Wrong handling of a USB ﬂash drive may result

in data loss or malfunction of the instrument.

• Use only USB ﬂash drives that are tested and installed by

your local Roche service representative.

• At any one time only one USB device can be in use. Before

inserting a USB ﬂash drive, check that no other USB device

is inserted.

• Before removing a USB ﬂash drive, choose the Eject button

in Windows.

• The default operating system (OS) conﬁguration provided

with the server should not be altered as this has implications

on the hardened OS conﬁgurations.

• To prevent a virus from infecting the uPath enterprise software,

use the USB ﬂash drive exclusively on the instrument. Do not

store other data on this USB ﬂash drive.

Data Security

7 uPath HER2 Dual ISH image analysis for Breast Algorithm Guide

Workﬂow for using the uPath HER2 Dual ISH image analysis for Breast algorithm

Materials needed

• uPath enterprise software

• uPath HER2 Dual ISH image analysis for Breast algorithm

• Breast tissue slides stained with the VENTANA HER2 Dual ISH assay (using the VENTANA Silver ISH DNP

and VENTANA Red ISH DIG Detection Kits) stained on the BenchMark ULTRA instrument

• VENTANA DP 200 slide scanner

Workﬂow

1. A breast tissue sample on a glass slide is stained with the VENTANA HER2 Dual ISH assay using a BenchMark ULTRA instrument.

2. Image acquisition (whole slide scanning) is performed with the VENTANA DP 200 slide scanner at 40x magniﬁcation at one z-plane.

3. Once digital images are acquired, these images are transferred from the computer associated with the VENTANA DP 200 slide

scanner to the image management system (IMS) on a centralized server.

4. Following transfer to the server, a case will be created in the uPath enterprise software. Case creation can occur automatically

through communication with the laboratory information system (LIS) using identiﬁcation information (i.e., tissue type and assay)

contained in the barcode label of the glass slide or entered manually into the uPath enterprise software (refer to uPath enterprise

software User Guide (PN 1018943EN).

5. If the uPath HER2 Dual ISH image analysis for Breast algorithm is installed (must be installed on a separate server from the uPath

enterprise software and the IMS) and a 40x image is accessioned with the appropriate stain and tissue type, the uPath enterprise

software then automatically triggers Whole Slide Analysis (WSA).

6. WSA automatically analyzes the entire scanned image.

7. Once WSA is completed, the pathologist is notiﬁed within the software that “analysis is complete.”

8. When the pathologist accesses the image they will have the ability to toggle a heat map that will highlight areas suitable for scoring

based on the presence of HER2 signals.

9. Once a suitable area is identiﬁed, the pathologist can select an ROI using the Quick ROI tool, which will automatically generate

a 0.4 mm x 0.4 mm square to score 20 representative tumor cells selected by the uPath HER2 Dual ISH image analysis for Breast

algorithm based on: cell size, number of HER2 and Chr17 signals and segmentation conﬁdence. If the pathologist does not agree

with the cell selection, they can remove and add cells by selecting cells on the ROI Details panel or within the ROI. The pathologist

can also delete the initial ROI and replace it with a new ROI on a more suitable region of tissue.

10. If the HER2/Chr17 ratio is between 1.8 and 2.2 the pathologist will be able to use the Quick ROI to draw a second ROI and analyze

a second set of 20 cells according to the VENTANA HER2 Dual ISH assay method sheet. However, if the score for the ﬁrst ROI is

>1.8 or <2.2 the quick ROI tool will be disabled and the HER2 gene status will be based only on the ﬁrst ROI. If the pathologist

does not agree with the score, they can manually override the algorithm.

Staining

• Tissue preparation and staining should follow the recommendations provided in the VENTANA HER2 Dual ISH assay method sheet.

• All proper controls should be reviewed and slides should be re-stained if the staining does not meet the guidelines outlined in the

VENTANA HER2 Dual ISH assay method sheet.

• The uPath HER2 Dual ISH image analysis for Breast algorithm requires use of the VENTANA HER2 Dual ISH assay, and any

additional material or supplies listed in the VENTANA HER2 Dual ISH assay method sheet, to stain tissues prior to analysis.

The VENTANA HER2 Dual ISH assay determines HER2 gene status in FFPE breast tissue stained with the VENTANA Silver ISH DNP

and VENTANA Red ISH DIG Detection Kits on a BenchMark ULTRA instrument.

8 uPath HER2 Dual ISH image analysis for Breast Algorithm Guide

Image Capture

The VENTANA DP 200 slide scanner is required for scanning of the slides. Images are required to be scanned at 40x magniﬁcation.

It is recommended that the tissue be free of folds and ink. If large sections of the image are out of focus, it is recommended that

the slides be rescanned. For further information on scanning, please refer to the VENTANA DP 200 slide scanner User Guide

(PN 1017149EN).

General Navigation: uPath enterprise software

The uPath enterprise software is meant to be customizable to individual and site needs including but not limited to report

conﬁguration and user interface. This Algorithm Guide will focus on the tools necessary for using the uPath HER2 Dual ISH

image analysis for Breast algorithm only. For further information on the uPath enterprise software please refer to the uPath

enterprise software User Guide.

9 uPath HER2 Dual ISH image analysis for Breast Algorithm Guide

Pathologist Workﬂow

Opening a Case

Images of Breast tissue stained with VENTANA HER2 Dual ISH DNA assay can be accessed by double-clicking on a case

or by selecting a case and pressing the viewer tab within the uPath enterprise software (Figure 1).

A screen with all images associated with a case will appear (Figure 2).

Figure 2

Figure 1

10 uPath HER2 Dual ISH image analysis for Breast Algorithm Guide

Once a glass slide stained with the VENTANA HER2 Dual ISH assay is scanned on a VENTANA DP 200 slide scanner at 40x, the

image is imported into the uPath enterprise software and associated with a case. The uPath HER2 Dual ISH image analysis for Breast

algorithm will automatically trigger WSA. Times to complete the WSA precomputing step depend on server speciﬁcations, image sizes

and number of images in the queue. When displayed, “waiting to start auto-analysis” speciﬁes the images are in queue and yet to be

analyzed and “analyzing” is used when WSA is being performed (Figures 3 and 4). Once the image is completely analyzed via WSA

in the uPath enterprise software, “analysis successful” will be displayed underneath the slide image within the viewer in the uPath

enterprise software (Figure 5). Images cannot be scored prior to successful WSA completion.

Heatmap

The WSA precomputing step allows for the uPath HER2 Dual ISH for Breast algorithm to generate a Heatmap available in the Slide

Navigator panel (Figure 6). The Heatmap can be toggled on and off using the Hide Heatmap button and Show Heatmap button on

the lower right hand corner of the Slide Navigator panel (Figure 6). The Heatmap is intended to identify areas with increased HER2

signals, deemed ideal for scoring based on the in the VENTANA HER2 Dual ISH assay Interpretation Guide. It ranges from yellow (low

HER2/Chr17 ratio) to red (high HER2/Chr17 ratio). No overlay will appear for areas (and cases) where the algorithm does not detect

ampliﬁcation. Despite what the Heatmap shows, it is necessary for the user to review the image as would be done in a manual read.

Figure 5

Figure 3

Figure 4

Figure 6

NOTE: In this example, a large portion of the tissue sample has a high HER2/Chr17 ratio as depicted by the dark red

regions in the Heatmap.

11 uPath HER2 Dual ISH image analysis for Breast Algorithm Guide

Scorable Cells Overlay

An overlay outlining scorable cells in red will appear when the image is at 20x magniﬁcation or greater (Figure 7). The uPath HER2

Dual ISH image analysis for Breast algorithm selects scorable cells based on the following criteria: size, presence of at least one

HER2 and one Chr17 signal, and segmentation conﬁdence (cell is clearly separated from neighboring cells). If any of the three

criteria are not met, the cell will be deemed not scorable and no overlay will appear. The overlay identiﬁes scorable cells allowing

the user to determine areas with a sufﬁcient number of scorable tumor cells.

Once the image has been reviewed and an area of interest is identiﬁed (area of tumor cells and appropriate staining internal

controls cells), use the Quick ROI tool to initiate analysis (Figure 8).

Figure 7

Figure 8

12 uPath HER2 Dual ISH image analysis for Breast Algorithm Guide

Upon selecting the Quick ROI tool, the following will occur:

1. A 0.4 mm x 0.4 mm ROI central to the viewer appears (Figure 9).

2. The overlay of all scorable cells will disappear within the ROI.

3. A bolded red overlay will appear, highlighting the 20 representative tumor cells as selected by the uPath HER2 Dual ISH image analysis

for Breast algorithm within this ROI (Figure 9).

4. The HER2 count and Chr17 count for each cell will appear within the ROI Details ﬂip-out Panel (Figure 10).

5. Ratio of HER2/Chr17, Total HER2 Signals and Total Chr17 Signals will be calculated and displayed within the ROI Details ﬂip-out Panel

(Figure 10). The ROI Details can be toggled by pressing the ﬂip-out icon (Figure 11).

Figure 11Figure 9

Figure 10

13 uPath HER2 Dual ISH image analysis for Breast Algorithm Guide

Pathologists can select any one of the 20 representative tumor cells with the red overlay to display the corresponding number

of HER2 and Chr17 signals within that cell as identiﬁed by the uPath HER2 Dual ISH image analysis for Breast algorithm.

The cell will now be outlined in green, and the corresponding count is highlighted in blue in the ROI Details ﬂip-out Panel

(Figure 12). Conversely, selecting one of the 20 cells from the Cell Count list found on the ROI Details ﬂip-out panel will

highlight the corresponding cell in green.

Figure 12

14 uPath HER2 Dual ISH image analysis for Breast Algorithm Guide

Quick ROI: Deletion

If a selected ROI is not optimal, it can be deleted. Select the Quick ROI by clicking anywhere on the ROI and then select the Delete

icon within the Slide Panel (Figure 13) or within the slide image near the ROI (Figure 14). A conﬁrmation window will appear. Select

Conﬁrm to delete the selected ROI. Select Cancel to retain the ROI.

Quick ROI: Replacing Cells

If a selected cell(s) identiﬁed by the uPath HER2 Dual ISH image analysis for Breast algorithm does not meet the guidelines

outlined in the VENTANA HER2 Dual ISH assay method sheet, select the cell by clicking on the center of the cell or selecting

the cell from Cell Count list. Delete the cell by selecting the Delete icon within the ROI Details ﬂip-out panel above the Conﬁrm

button (Figure 15). Upon selection of the Delete icon, the cell HER2 and Chr17 count will be removed from the cell list and the

corresponding highlighted cell will be removed from the ROI (Row 8 in Figure 16). The Add icon will now be activated (Figure 16).

Select the Add button and draw around the new cell that should be scored.

Figure 14Figure 13

Figure 15

Figure 16

15 uPath HER2 Dual ISH image analysis for Breast Algorithm Guide

Internal Control Valid Conﬁrmation

The uPath HER2 Dual ISH image analysis for Breast algorithm requires the user to conﬁrm that valid internal controls are present

within the ROI (Figure 17) before being able to proceed to sign out. The deﬁnition of valid internal control cells can be found within

the VENTANA HER2 Dual ISH assay Interpretation Guide. If the user deems that the internal control within the ROI does not meet

the criteria deﬁned by the VENTANA HER2 Dual ISH assay, the ROI should be deleted and a new Quick ROI selected. The default

selection for Internal Control with the ROI will be Not Valid (Figure 18).

NOTE: In order to proceed to the Conﬁrmation step, 20 representative tumor cells must be scored and the Internal

Controls must be marked as Valid within the ROI Details Panel.

ROI Conﬁrmation

If all the selected cells are acceptable and the user marks Internal Controls as Valid, the HER2/Chr17 Ratio can be conﬁrmed using the

Conﬁrm button (Figure 19).

Figure 17

Figure 18

Figure 19

16 uPath HER2 Dual ISH image analysis for Breast Algorithm Guide

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Roche uPath IVD User manual

Roche uPath IVD User manual

Roche uPath IVD User manual

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