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Diagnostics Oncology, Training and education, Histology, Precision medicine, Biochemistry and molecular biology, Companion diagnostics

Quantifying Quality

What led you and Sarah Wedden to found CADQAS?

My career has been a great grounding for this project – I was very fortunate to be at the heart of the developmental work on immunohistochemistry (IHC) and in-situ hybridization (ISH) back in the 1980s, under the guidance of one of the world’s leading academic researchers in the field at that time, Professor Peter Isaacson. Applying these technologies to cancers previously diagnosed using morphology and tinctorial stains revealed that many of the old diagnostic methods were seriously flawed. Developments like IHC allowed cancers to be more reliably classified, which meant a growing number of tailored treatments could be applied – IHC and ISH testing have underpinned much of the improvement in cancer care today. And in some patients, the response to tailored drugs (for example, giving Herceptin to HER-2 positive breast cancer patients) can be phenomenal.

Since 1985, I have also been involved with external quality control for IHC and ISH, after being invited by those who initially started the activity – Gerry Reynolds (Mount Vernon Hospital), and Brain Mepham (Southampton General Hospital). In 1988, this work was reviewed and was recognized by the Department of Health, and subsequently included as part of the UK National External Quality Assessment Service (UK NEQAS). The scheme oversees the quality of IHC and ISH testing performed in diagnostic laboratories in both the UK and 50 other countries, and supports labs struggling to meet the appropriate standards. As scheme director, part of my remit is to ensure that there are appropriate training programs available for laboratory staff to update their skills. The scheme also has a duty to give staff who are having testing issues somewhere to go in order to discuss their problems, and work to address them. In my opinion, the changing healthcare environment in the UK has caused laboratories to become more and more competitive. This means the “help thy neighbor” approach is quietly disappearing, while at the same time, the cost of running courses in many locations has become prohibitive. These issues make training and QA programs more important than ever.

So, when the opportunity, contributed to in part by a generous donation from Roche, arose to set up an independent, “not for profit” community interest company, to support the education and training of laboratory staff, Sarah Wedden (co-founder of CADQAS) and I grabbed it! Poundbury provides an exceptional environment for our work – and my background in tissue testing and QA gives me a wealth of experience to draw on in this new role.

The changing healthcare environment in the UK has caused laboratories to become more and more competitive.

What role will CADQAS have within the Institute?

Before CADQAS, there was already work going on to support the NEQAS program in the nearby Dorset County Hospital. This was at the invitation of the lead pathologist, Corrado D’Arrigo. It was through funding from Roche Diagnostics that we were able to appoint a very able research scientist, Sarah Wedden. Sarah and Dr D’Arrigo have worked closely together since early 2013 on projects in colorectal cancer (CRC), prostate cancer and melanoma. The information they have produced is very informative, and they have already given presentations both in the UK and overseas. Although not cutting edge science, this educational and supportive work is crucial for labs that are struggling to keep up with the demands of the 21st century.

Improving the approach to cancer testing is also the cornerstone of how CADQAS will work within PCI – a number of vitally important markers, for instance in CRC, are not universally embraced, which can lead to patients failing to receive the right treatment. Adoption of the new and novel diagnostics can often be slow, and there are already examples of potentially life-saving tests which are not being used by a significant number of cancer testing centers, such as EML-4Alk and ROS-1 testing for lung cancer.

CADQAS will help both by offering training and support, and in the future, we aim to help improve the diagnostics themselves. Both our company, and our network have considerable experience in this field. Combined, we can influence change for the better. From a QA angle, we will also be involved in investigating issues with tests – for example, should a batch of reagents fail, we will work to find out why.

Clearly, Dr D’Arrigo, Sarah and I do not have all the necessary know-how to deliver truly comprehensive teaching programs. We hope to bring experts from the UK and beyond to PCI to lend their expertise to our courses. We want to involve industry, too, and are already speaking to a number of pharmaceutical and analytical companies about our work. We aim to create programs that benefit everyone in the field, but above all, lab staff and the patients they serve.

What challenges do you anticipate, and how will you overcome them?

The UK NEQAS Scheme for IHC and ISH has already successfully improved HER-2 testing for breast cancer in the UK, and breast cancer hormonal receptor testing has greatly improved, too. As research and clinical practice evolve, we need to continue to safeguard the quality of the assays being performed, as well as the interpretation of results.

For example, we are currently discussing ways to support the introduction of PDL-1 testing into the community, and how to train and provide robust external quality control systems. PDL-1/PD1 therapy is likely to significantly improve outcomes in a range of cancers, including lung, skin, bladder and breast. The companion diagnostics for these treatments are likely to be provided by just two suppliers, for the four different check-point inhibitor targeted therapies.

Potentially, this means four assays, with four different interpretations. This represents an immense challenge – each assay must be interpreted as accurately as humanly possible, and at the same time we are reliant on the assay providers to provide consistency from batch to batch.

However, our laboratory is now starting to have access to some of these assays, and we are in a position to provide a range of cancer cases that will be stained with the relevant IHC companion diagnostic on glass microscope slides. We can then digitize the slides in high resolution, and create a portable, digital teaching set, and give lab staff, both medical and scientific, the knowledge they need to interpret tests correctly.

I am proud to say that the quality of IHC and ISH performed in UK laboratories is among the highest in the world today. But with new and highly complex diagnostic markers on the way, our external QA system will be severely challenged if we don’t take the necessary steps to support the related companion diagnostic in the field – something that is absolutely imperative if we are to make sure that every patient gets the right therapy for their cancer.

 

Putting Pathology at the Heart

By Corrado D’Arrigo

Poundbury Cancer Institute aims to put pathology at the forefront of cancer research, and bring industry, national healthcare service and quality assurance together to expand the use of companion diagnostics and important biological markers.

Industry Insights

Christopher Hudson is Director of Tissue Diagnostics UK and Ireland at Roche, the multinational life sciences company that supports the Poundbury Cancer Institute through funding and research collaboration.

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About the Author
Roisin McGuigan

I have an extensive academic background in the life sciences, having studied forensic biology and human medical genetics in my time at Strathclyde and Glasgow Universities. My research, data presentation and bioinformatics skills plus my ‘wet lab’ experience have been a superb grounding for my role as an Associate Editor at Texere Publishing. The job allows me to utilize my hard-learned academic skills and experience in my current position within an exciting and contemporary publishing company.

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