Assay Validation and Interdisciplinary Communication

Transcript: John R. Gosney, MD, FRCPath: Quality assurance and validation of assays is, of course, absolutely crucial. We have to know that the same mutations or gene rearrangements will be found in the same tumor by any laboratory anywhere that does the test. I also need to know when I’m looking at immunochemistry that the features in the sections I’m looking at will be exactly the same, whether that section is prepared in my laboratory, or the one in the next town, or the one in a different country.

And it’s very important to maintain that quality. Firstly, it’s very important to use an approved assay system. FDA approval in the US is very important. And European approval throughout Europe, CE [European Confornmity] marking, is very important. Because that essentially is a mark of quality of the assay.

Over and above that, every laboratory has to validate the test they’re using. There has to be validation between laboratories. The different assays for PD-L1 [programmed death-ligand 1] expression, for example, are a very good illustration of how this works. There has been quite a lot of harmonization now among the different assays available. But that doesn’t necessarily mean you can move from one to the other without validating your new platform, your new antibody against the old one. So in France, intralaboratory comparisons are very important.

And there are organizations that monitor and advise on maintaining that quality. Naquasone in the UK, for example; Nordic IQ in Europe; and there is now a global organization, IQN PATH, which oversees quality-assurance schemes, technical-quality-assurance schemes, really throughout the world. And it’s very important to embrace these regulatory and quality-assurance standards. It’s crucial in order to know that what we have, eventually concluding, is the right answer.

Communication among colleagues is absolutely crucial. And the obvious form for that is the tumor board in the United States, the multidisciplinary team meetings [MDT] in the UK, and similar groupings throughout Europe. And in the room when patients are being discussed, you will have, or you should have, everyone who has contributed. So you will have not only the clinician who’s taken the biopsy but also the pathologist, the radiation oncologist, the medical oncologist, the surgeon, a physician. You will have lung cancer specialists and nurses. Everybody plays a role. And this is very important.

For example, in Liverpool, I attend 2 large MDT meetings every week, which cover the city. And that gives me an opportunity, for example, to constantly remind my clinical colleagues, who are obtaining the biopsies that I am crucially dependent on, to please keep getting as much as you can for me—this is important. And it’s important, for example, if I have specimens that are inadequate to feed that back. And that sort of communication is very important.

A problem that we are beginning to see with more centralization of testing, especially when specimens are sent to stand-alone laboratories where they don’t have a presence is that communication is lost, and that crucial link among the person who obtains a specimen, the clinician; the pathologist who analyzes it; and indeed the users of that information—the oncologists, the surgeon, whatever—and ultimately the patient indirectly is lost. It’s very important to keep that integration.

Transcript Edited for Clarity