Precision testing – leica bond-max system – Leica Biosystems HER2 FISH System - 30 Test User Manual

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Leica Biosystems Leica HER2 FISH System - 30 Test Instructions for Use TA9217 EN-CE-Rev_D 08/04/2013

English

Precision Testing – Leica BOND-MAX System

A. Within Run Precision Study

The within run precision study was performed in a randomized and blinded fashion. Within

run precision testing of the Leica HER2 FISH System - 30 Test was evaluated at a single

investigational site on 540 previously HER2 characterized TMA samples containing formalin-

fixed paraffin-embedded breast cancer cases. The use of TMAs for the determination of

within run precision enabled a larger volume of cases covering a wider range of HER2

expression within a single run on a single instrument.
On enumeration of the slides stained in the Within Run Precision Study, 532/540 cases

evaluated demonstrated a concordant result giving an overall concordance of 98.52% with

a lower 95% CI of 97.10%.

B. Within Instrument Precision Study

The within instrument precision study was performed in a randomized and blinded fashion.

Within instrument precision testing of the Leica HER2 FISH System - 30 Test was evaluated

at a single investigational site on 1620 previously HER2 characterized TMA samples

containing formalin-fixed paraffin-embedded breast cancer cases. The use of TMAs for the

determination of within instrument precision enabled a larger volume of cases covering a

wider range of HER2 expression within multiple runs on a single instrument.
On enumeration of the slides stained in the Within Instrument Precision Study, 1620/1620

cases evaluated demonstrated a concordant result giving an overall concordance of 100%

with a lower 95% CI of 99.82%.

C. Between Run Precision Study

The between run precision study was performed in a randomized and blinded fashion.

Between run precision testing of the Leica HER2 FISH System - 30 Test was evaluated

at a single investigational site on 900 previously HER2 characterized TMA samples

containing formalin -fixed paraffin-embedded breast cancer cases. The use of TMAs for the

determination of between run, day-to-day precision testing enabled a larger volume of cases

covering a wider range of HER2 expression to be tested between runs on different days.
On enumeration of the slides stained in the Between Run Precision Study, 894/900 cases

evaluated demonstrated a concordant result giving an overall concordance of 99.33% with

a lower 95% CI of 98.55%.

D. Between Laboratory Precision Study

The between laboratory precision study was performed in a randomized and blinded

fashion. Between laboratory precision testing of the Leica HER2 FISH System - 30 Test

was evaluated between three investigational sites on 513 previously HER2 characterized

TMA samples containing formalin-fixed paraffin-embedded breast cancer cases. The use of

TMAs for the determination of between laboratory precision testing enabled a larger volume

of cases covering a wider range of HER2 expression to be tested between runs on multiple

instruments.
On enumeration of the slides stained in the Between Laboratory Precision Study, 510/513

cases evaluated demonstrated a concordant result giving an overall concordance of 99.42%

with a lower 95% CI of 98.30%.

E. Between Observer Precision Study

The between observer precision study was performed in a randomized and blinded fashion.

Between observer reproducibility testing of the Leica HER2 FISH System - 30 Test was

evaluated between three investigational sites. A single experienced observer at each

investigational site was used. Eighteen whole section breast cancer cases were used for

between observer precision, reflecting samples types used in the clinical setting.
On enumeration of the slides stained in the Between Observer Precision Study, 53/54 cases

evaluated demonstrated a concordant result giving an overall concordance of 98.15% with

a lower 95% CI of 90.11%

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