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HER2-CONNECT™



Visiopharm's HER2-CONNECT module assists the pathologist in the scoring of HER2 IHC stained breast cancer specimens by providing continuous readouts of membrane connectivity which are readily translated into classical diagnostic scores. The algorithm can be applied to digital images acquired from any type of whole slide scanner.

Intended use

HER2-CONNECT is intended for use with digital images as an accessory to in vitro diagnostic test for analysis of HER2 receptor protein for the detection and semi-quantitative measurement of HER2/neu (c-erbB-2) in formalin-fixed, paraffin-embedded normal and neoplastic breast tissue.

It is indicated as an aid to the pathologist in the assessment of breast cancer patients for whom treatment with trastuzumab is being considered.

Principle of Procedure

HER2-CONNECT is a software module which may assist pathologist in the scoring of breast tissue sections stained for the presence of HER2 protein by immunohistochemistry (IHC). The algorithm determines the membrane connectivity, a single dynamic measure (between 0 and 1) of the size distribution of HER2-stained membrane fragments within a user-defined region of interest (ROI), which is readily translated into a classical diagnostic score (0, 1+, 2+ or 3+) in accordance with the ASCO/CAP-guidelines.

The algorithm can be applied to digital images acquired by whole slide scanner. For images of breast tissue sections stained by HER2 IHC, the algorithm will determine the connectivity for the entire image in one or more preferred ROI outlined by the user. The manual outlining of ROI is simple, since the algorithm is insensitive to unstained stromal tissue, and these regions therefore do not have to be manually excluded. Thus, the two major reasons for outlining are to include relevant invasive cancer, and to exclude possible ductal carcinoma in situ (DCIS) regions, which may have a clinically irrelevant high HER2 score, and tissue folds or other artifacts, which may appear as positively stained membrane.

Clinical Performance

The clinical performance of HER2-CONNECT has been determined by three studies comprising 796 cores prepared from breast carcinomas from 222 patients, using 6 expert reviewers/pathologists and representing 178 clinical pathology laboratories. Results were calculated and summarized below using her2/neu gene amplification determined by HER2 FISH pharmDx™ kit (Dako) as reference in accordance with the ASCO/CAP-guideline criteria. Performance data from manual reading, where available, is provided in grey for comparison.

Sensitivity Specificity Inconclusive HER2 IHC Test Scanner Study
100% (77/77)
100% (73/73)
100% (127/127)
97.3% (100/113)
5.11% (11/215)
13.5% (29/215)
HercepTest NanoZoomer 1
100% (71/71)
100% (75/75)
100% (134/134)
100% (125/125)
4.65% (10/215)
6.98% (15/215)
Pathway HER2 NanoZoomer 1
97.5% (39/40)
100% (39/39)
97.4% (75/77)
97.0% (64/66)
2.50% (3/120)
12.50% (15/120)
HercepTest VL4 2
90.7% (39/43)
100% (39/39)
100% (68/68)
96.9% (63/65)
0.89% (1/112)
7.14% (8/112)
Pathway HER2 VL4 2
63.9% (53/83)
65.4% (51/78)
98.1% (405/413)
98.3% (393/400)
1.59% (8/504)
5.35% (27/505)
Pathway HER2 ScanScope 3
98.2% (333/339) 99.4% (505/508) 3.75% (33/880) Multiple NanoZoomer 4
93.7%
(612/653)
99.0%
(1314/1327)
3.23%
(66/2046)
All studies combined


In summary, HER2-CONNECT showed 93% agreement with manual scoring, 94% diagnostic sensitivity and 99% diagnostic specificity.

For further information please see HER2-CONNECT Package Insert, see the webinar Towards a robust automated scoring of HER2 IHC or contact Visiopharm.

References (external links)

Stereology
There is currently no Webinars planned.

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Digital Pathology
Ductal Carcinoma in Situ (DCIS): Revealing the Hidden Layers
Presented by invited key-speaker and Martin Kristensson, MSc
December 10, 2014
Read Abstract

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Digital Pathology Congress
London Heathrow, Uk
December 4-5, 2014

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Centralized Training Course
May 4-7, 2015
Copenhagen, Denmark

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