The Changing Landscape in Molecular Testing

Transcript:John R. Gosney, MD, FRCPath: It’s very important that the central reference laboratory and the central unit where lung cancer is managed in the context of a multidisciplinary team, or a tumor board, communicates very well with the community hospitals. It is still the case, certainly in the UK, that the majority of lung cancer is diagnosed in district general hospitals, community hospitals. And the biopsy, therefore, will be obtained by clinicians in those community hospitals, and the initial pathological analysis will be by pathologists in those community hospitals. And it’s very important that those practitioners need to feel a part of the entire enterprise.

And education of those clinicians is very important, because it’s very easy to forget when you’re working in a specialist center that when you get outside into the wider world, there is not that intensity of experience and that level of knowledge. And it’s important to maintain those links, because ultimately it’s engagement of these very important practitioners at the start of the process that determines the quality of the specimen, the way it’s handled by the pathologist, and ultimately what we in the center can do in terms of making the very best of that in profiling the tumor so that the patient could be managed appropriately. So education is very important.

One of the major changes that is about to occur in England is the centralization of genomic testing of all solid tumors into 7 genomics laboratory hubs, GLHs. And this is driven by NHS [National Health Service] England and is a very ambitious, laudable plan. Because of course it will bring economies of scale; it will bring uniformed technology; it will bring uniformity of standards and quality assurance. And there are clearly advantages. However, it will inevitably dismantle some of the very well-established and very efficient more local networks, which have been developed over the last decade since we first started profiling non—small cell lung cancer and which actually work very efficiently. They might not use the latest NGS [next-generation sequencing] technology. They might use single-gene testing as we do in Liverpool, but they are very efficient and very quick, and they’re very flexible.

And I’m concerned that when this change takes place, at least for a while, there will be quite severe disruptions to the smooth running of these local networks. And now of course that’s sort of a local organization. It’s not present everywhere across England; it’s very patchy. And centralization in some areas will bring enormous advantages, where there have been problems over the last 10 years, because there has not been an integrated system for testing.

But we have to be careful that we don’t throw the baby out with the bathwater here, if I can put it that way. And there are other problems. For example, NGS technology tends to require more tissue than single-gene testing, and we all are aware that the specimens that we often get to test as pathologists are very small. And the advances in the techniques used to get them, like EBUS [endobronchial ultrasound], radiological sounds, bronchoscopy, and even aspiration of lymph nodes, that have developed over the last decade tend to get small specimens.

Therefore, we have to try to manage that. And inevitably, because of centralization and large-panel testing, the turnaround time will increase. It will be less efficient. So there are disadvantages to this. And currently this change, this transition, is projected to take place on April 1, 2020. This is imminent, and I’m not entirely sure there’s a general awareness about what’s happening here. It’s a laudable plan, and it’s extremely ambitious. But I think we have to be aware that for a while, at least, this might cause some quite significant disruptions with the well-organized, more local testing that’s established in large parts of England.

Transcript Edited for Clarity