Questions over quality of outsourced molecular testing

At an Executive Committee meeting of the National Cancer Control Programme (NCCP) in June, the minutes of which were seen by MI through Freedom of Information legislation, Chairperson of the Programme’s Cancer Molecular Diagnostics Advisory Group Prof Maeve Lowery reported there are issues in relation to development of capacity for new tests in an “unplanned/uncontrolled way”, across a range of laboratories.

The meeting agreed that funding for new predictive tests should be funnelled early through the NCCP so that capacity is built in a structured way and processes developed for other drugs and companion tests that become available.

The outsourcing of tests was also discussed.

“Feedback has been received from all centres on tests currently being outsourced (except Galway),” according to the minutes.

“There is uncertainty around QA. Capacity would have to be developed to deal with testing internally and the explosion of genetic testing coming down the line. Every drug coming through will have associated test. Currently, the necessary skilled people are not in place.”

The Molecular Diagnostics Working Group has developed a new framework document for predictive molecular diagnostics, which was recently published by the NCCP.

At a meeting of the Executive Committee in September, Prof Lowery commented that the group does not have the ability to allocate resources.

She also noted that “there is a lot of testing coming through (multiple drugs coming through with multiple tests) over the next few years, with little downstream capacity”.

Prof Lowery stated how the group is going to draft a briefing paper on testing resources required for the next five years.

The challenges of testing PDL-1, which is an immune-related biomarker, were noted.

“PDL-1 testing is challenging, with various complexities involved, ie, time taken to read a slide, as well as tumour sensitivities,” according to the minutes. The Executive Committee agreed that a “broad strategic approach” on PDL-1 testing is required, rather than examining the issue on a case-by-case basis.

The September meeting also discussed the suspension of the familial breast screening service in St James’s Hospital, Dublin, due to a mammography capacity issue.

Consultant Medical Oncologist in St James’s Prof David Gallagher stated “he does not have capacity to follow up patients who have not tested positive for a gene”.

It was agreed that follow-up care should be provided by the referring hospital after testing and that the “surveillance population” should be quantified.