Targeted therapies available for the treatment of cancer are increasingly being considered as
standards of care in routine clinical practice. These therapies, such as Crizotinib for non-small cell
lung cancer and Cextuximab for colorectal cancer are recommended for single tumour types.
However, third generation therapies targeting fusion genes have received licensing approval and are
being offered to patients, some of them agnostic of tumour type. This represents a step change in
cancer treatment and the promising response rates observed suggest the potential for considerable
clinical benefits.
There are a variety of testing strategies that could be used to identify fusions across tumour types but
most testing is predicted to use RNA-based NGS as the costs and resources required to implement it
are falling over time. Evidence from EQA schemes shows that the introduction of any new test is
usually accompanied by a high diagnostic error rate (often up to 25%). Incorrectly genotyping patient
samples could result in harm, and consequently there is a need for EQA provision at the point of
regulatory approval and the start of clinical diagnostic testing. This will facilitate early oversight of the
testing process, drive harmonisation, and improve the quality of the testing process.
This year, IQN Path will launch the project and facilitate a single IQN Path badged pilot EQA scheme
for fusion gene testing. The aim is to ensure that the quality of laboratory testing is audited from the
point of clinical test introduction. To this end, it is furthermore proposed that the scheme be free at
the point of access to any laboratory that may wish to participate.
Further information on participating or supporting the study may be obtained from
executive@IQNPath.org
Dr Simon Patton