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Table 1 Inclusion criteria for the Idylla™ test

From: Clinical performance evaluation of the Idylla™ EGFR Mutation Test on formalin-fixed paraffin-embedded tissue of non-small cell lung cancer

 

Inclusion criteria

1

Male or female patients ≥18 years of age

2

Samples can be used for investigational purposes according to the applicable laws

3

Histological confirmed primary or metastatic NSCLC with known EGFR status (valid result with the version 2 of the comparator test)

4

For Idylla™ testing: one slice or slide with a minimum of 10% tumor cells of the total tissue used (if this is not obtained, macro-dissection is to be performed to reach at least 10% tumor cells in total tissue area used)

5

FFPE blocks from the institute, which preferably had a maximum fixation time of 48 h (routine procedure) and are preferably not older than 5 years after the date of collection, stored at ambient conditions