HHE Pathology and diagnostics supplement 2018 | Page 7

evaluation
71 36 31
20 12 12
10 5 5
89.8 %
98.1%
80.0%
70.4% 94.4% 100.0%
3.4% 0.6% N/A
(24/710) (1/180)
21.1%
2.8% N/A
every subscheme, at least 70% of the participants
were successful according to the pre-defined
criteria. For the EGFR and ROS1 FISH subschemes,
the percentage of successful participants was the
lowest, in concordance with the higher number of
laboratories analysing at least one of the samples
incorrectly. On sample and laboratory levels, more
technical failures were observed for ROS1 compared
with other markers.
Although reporting scores were all above
80% (Table 1), only 43–52% of the participants
were able to correctly include the clinical
interpretation of the analysis result, depending
on the marker of interest.
Discussion
Our results demonstrate decreased error and
technical failure rates on sample level in 2016
compared with previous reported results. 7,8
Average reporting scores were on an upwards
trajectory since 2012. 11 Recently, longitudinal
research of EQA data has indeed confirmed that
obtaining laboratory accreditation 12 and frequent
EQA participation 8 has a positive influence on
a rapid implementation of novel biomarkers in
routine practice. Although evaluated for colon
cancer, EQA data also shows that the methods,
region and estimations for neoplastic cell
estimation are highly variable within Europe. 13
Despite improvement being obvious, assessing
the current state of NSCLC biomarker analysis
in 2016 revealed the importance of additional
research to improve several indispensable
elements, especially in the continuously evolving
field of personalised medicine, where new
biomarkers and technological advances are
key and where incorrect results could lead
to incorrect therapy decisions. 4,10 It has been
hypothesised that marker-specific challenges,
such as the estimation of the neoplastic cell
content for EGFR, and the recent addition of
ROS1 testing to the drug label of crizotinib, 8,14
might be at the base of these findings.
Therefore, we recommend a multi-level research
strategy with the intention to improve and
maintain the quality of biomarker analysis
on the long term.
4.8% 2.8% N/A
(34/710)
(5/180)
29.6% 11.1% N/A
63 28 N/A
88.5% 81.3% N/A
51.9% 47.6% N/A
Molecular diagnostic laboratories
Even though EQA schemes reflect if a sample
outcome was correctly assigned, no information
is available on the exact cause in case of an error
or technical failure. Some errors could be due to
profound problems with laboratory methodology,
while others might include sample mislabelling
or typing errors. Additional research is essential
to evaluate the exact time point (pre-, post-, or
analytical phase) of problem occurrence.
Individual monitoring of EQA participants over
time could reveal such critical time points in
the total testing process. Moreover, this approach
allows to evaluate if problems are inherent to
a specific or the swit ch between two methodologies/
sample types. Additionally, it is useful to map the
laboratories’ processes to prevent incorrect results
and identify an optimal quality framework to
tackle phase-, method- and sample-specific
problems. A first analysis of this kind in 2016
revealed that error causes are indeed biomarker-
specific, with the majority of problems being
situated in the pre-analytical phase for EGFR
7
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