2 O N C O LO G Y What EU/UK deals may mean Post-Brexit and future cancer research Creating robust scientif Mark Nicholls reports on an online experts debate focused on how Brexit could affect research Despite Brexit uncertainties, four leading UK cancer research experts expressed optimism for continued pan-Europe- an collaboration and innovation dur- ing the online panel debate ‘Brexit deal: What it really means for cancer research and innovation’ hosted by the National Cancer Research Institute (NCRI). The experts, Dr Sheuli Porkess, Professor Richard Sullivan, Emlyn Samuel, and Jim Elliott, were chaired by Professor Pam Kearns, Chair of Clinical Paediatric Oncology at the University of Birmingham. Steep challenges Having reviewed the current UK research and innovation landscape, the panellists discussed the outlook from the perspective of key UK organ- isations. Also considered was the potential impact of the coronavirus pandemic on cancer research, science, innovation, funding and treatment in the future, and also the long-term economic effect of Covid-19 interna- tionally. Porkess noted that Brexit and the pandemic had brought disruption to global R&D and healthcare systems, but had motivated the Association of the Britisch Pharmaceutical Industry (ABPI) to be even more focused on being internationally competitive with commercial clinical trials. Concerns include continued partici- pation in EU programmes, data ade- quacy, clinical trial supplies, moving products for research and additional hurdles for equipment and consuma- bles imports, regulation of trials, and immigration factors. ‘It’s tough at the moment with the effects of Covid-19 and we also know some practicali- ties of Brexit have not been worked through,’ Porkess said. ‘But, we have a recovery resilience and growth pro- gramme in place that gives us oppor- tunities we’ve not had before to get through those changes, to ensure Research in a laboratory recovery from the pandemic and drive that growth in research that we all want to see.’ The Cancer Research UK (CRUK) has worked with the UK government, and across Europe, on the implica- tions of Brexit since the 2016 referen- dum to ensure, whatever the outcome, that ‘cancer patients and research is protected as far as possible’, Samuel pointed out. Continuity across borders Key topics were the regulatory envi- ronment for clinical trials, immigration and movement, as almost a third of CRUK trials involve patients from EU member states. ‘We’ve also been working to ensure that patients can continue to access new and innovative medicines as well as the supply of existing medicine across borders, and also working on monitoring broader research envi- ronment with the Horizon Europe Association – one of the real posi- tives to come out of the deal,’ Samuel added. ‘There was a huge relief that there was a deal; it provides a plat- form for further development and negotiation of the UK relationship with the EU.’ Sullivan said his team had examined the effect of Brexit on cancer research with regards to the socio-economic impact; the mechanistic aspects of collaboration and partnership, such as policy changes around the ability for people to move freely across borders; and the political attitude to collabora- tions. While the UK had previously enjoyed an enormous amount of EU funding, he feared it now risked no longer being centre stage in major initiatives. Elliott commented that it still remained difficult to see clearly what the issues may be because of the pan- demic, but added: ‘The characteristic of the cancer patient movement is a “can-do” attitude, so I’m reasonably confident that the UK research com- K U R C : t h g i r y p o C Professor Pam Kearns is Chair of Clinical Paediatric Oncology at the University of Birmingham, an Honorary Consultant Paediatric Oncologist at Birmingham Women and Children’s Hospital, and Director of the University of Birmingham’s Institute of Cancer and Genomic Sciences and Director of the Cancer Research UK Clinical Trials Unit (CRCTU). Emlyn Samuel leads the policy depart- ment at Cancer Research UK and a team of policy, public affairs and campaigning experts who work to drive policy change up to international levels. Jim Elliott is a member of the National Cancer Research Institute (NCRI) Consumer Forum and is part of the NCRI Consumer Involvement Advisory Group. munity will find ways to carry on and collaborate across Europe, as we do in the rest of the world.’ A new relationship Pre-Brexit free movement, ‘a sig- nificant enabler of collaboration’, has gone, causing Elliott concern over paediatric oncology and rarer cancers, and the possibility that UK patients may not be eligible to take part in trials being run in the EU. He warned of continuing uncertainty as a new relationship is developed with the EU on immigration and regula- tory status ‘…and how we will con- tinue to partner with the EU on clini- cal trials and research going forward’. Discussion flowed on. Question: Might the UK, being outside the European Medicines Agency (EMA), offer speedier approval of drugs and therapies from the Medical and Healthcare products Regulatory Agency (MHRA), making it an attrac- tive test bed for innovation? Sullivan said the new Horizon Europe programme remains impor- tant, with the Erasmus programme no longer accessible to the UK and replaced by a ‘global talent visa’, with concerns that movement between the UK and Europe for research would become more complex and costly. How will Brexit affect funding that enables cross border research? While Covid has impacted on charitable income, the panel felt UK participation in the Horizon Europe research and innovation framework programme was important. ‘The UK has some of the best early phase clinical trial activ- ity, not just in Europe but probably in the world,’ Sullivan said, pointing out the UK’s ‘amazing infrastructure for Pharmaceutical physician Dr Sheuli Porkess is Interim Medical Director at the British Pharmaceutical Industry Association. She began her career in the NHS and has held numerous medical leadership roles in companies at a nation- al, regional and international level. Richard Sullivan is Professor of Cancer and Global Health at King’s College London, Director of the Institute of Cancer Policy, and co-Director of the Conflict and Health Research Group. clinical research’ to run complex trials. Data protection and exchange of personal data with GDPR regula- tions is still an issue, but confidence remains over an agreement on data adequacy for data flow. CRUK funds 30% of research fellows, and 43% of post-doctoral researchers from the European Economic Area (EEA) who will hopefully be able to ‘work around Brexit’. On the upside, the Brexit deal provides 90-day visa-free visits. In conclusion, Kearns questioned the panel’s optimism about post-Brex- it cancer research. Porkess is optimis- tic about UK-EU research collabora- tions, and Sullivan believes research relationships built up over years will remain strong. Elliott added that patient anxiety could be eased with good communication and engage- ment, while Samuel feels positive about conversations over ‘moves to bolster’ the UK’s life sciences and clini- cal trial environment. n a e l c M k i r E / h s a l p s n U : e c r u o s e g a m I Due to compromised immune systems, cancer patients are at higher risk of contracting infec- tions. How does cancer impact on patients who also contract Covid-19? To collect this data, four cancer registries, one in the EU, one in the UK, two in the USA, have been established. Report: Cynthia E. Keen The first large, multi-institution study of the impact of Covid-19 was conducted in Wuhan, China, and presented at the virtual American Association for Cancer Research (AACR) Annual Meeting 2020 in April. The study included 105 can- cer patients and 536 age-matched patients without cancer, and showed that Covid-19 patients with cancer had higher risk in intensive care unit (ICU) admissions and mortality. However, at the same conference, researchers from Gustave Roussy Cancer Campus in Villejuif, France, reported that 137 cancer patients diagnosed with the coronavirus in March did not have more lethal or aggressive disease than patients without cancer in the global popu- lation. Such conflicting reports sup- ported the urgent need to acquire long-term global data. The UK Coronavirus Cancer Monitoring Project The UK Coronavirus Cancer Monitoring Project (UKCCMP) (www.ukcoronaviruscancermonitor- ing.com), established in mid-March 2020, was the first Covid-19 clinical registry to enable near real-time reports to frontline physicians about the effects of Covid-19 on cancer patients. Its objective is to monitor the impact of Covid-19 and enable oncologists to gain crucial insights and inform clinical- and infrastruc- ture-based decision making. A live clinical data dissemination system provides a daily update to an inter- active website; weekly reports are sent to individual UK cancer centres and clinicians. In its first five weeks EUROPEAN HOSPITAL Vol 30 Issue 1/21

4 L A B O R AT O RY Wako ß-glucan test Better detection and diagnosis of fungal infections Beta-glucan tests are proving to be pivotal in the better detection and diagnosis of fungal infections. As a robust compli- mentary test for traditional testing techniques and biomarkers, it is helping clinicians deliver rapid results and offering greater reassurance in more accurately identifying such infections. ß-glucan testing, which is an in vitro diagnostic test, is regularly used at University Hospitals Leuven in Belgium. ‘Although it is not a specific test for a particular fungal disease, the value is its use in conjunction with other conventional tests, such as microscopy and culture, and biomarker detections,’ explained Professor Katrien Lagrou, head of the Molecular Diagnostics department at the university. Report: Mark Nicholls fungal diseases are a Invasive major worldwide health problem and affect immunocompromised patients, such as those undergoing intensive-care treatment, and people with chronic disorders – particu- larly lung diseases. Most infections are caused by Aspergillus, Candida and Pneumocystis jirovecii, with early recognition and diagnosis cru- cial to improve patient outcomes. Guidelines the European Confederation of Medical Mycology for Candida – which will be updated imminently – and Aspergillosis, rec- ommend the use of a ß-glucan test for their detection. from In addition, PCR (polymerase chain reaction) is the first line test in non-HIV Pneumocystis jirovecii Pneumonia but it has drawbacks that the ß-glucan test can help overcome. ‘It’s not always possible to have a bronchoalveolar fluid sample to perform a PCR test and Toxinometer MT-6500 system by FUJIFILM Wako Chemicals Europe GmbH for the kinetic turbidimetric measurement of ß-D-glucan have their own value and they do provide complimentary information, and the ß-glucan test is one of those tests.’ The Wako ß-glucan test – evalu- ated at the Leuven centre – is an in vitro diagnostic test for the quantitative determination of (1 3)-ß-D-glucan in serum or plasma and a marker of invasive fungal infections. The assay is performed on the Toxinometer MT-6500 device developed by FUJIFILM Wako Pure Chemical Corporation. The test may also have a role with Covid-19, where invasive aspergil- losis is a complication in Covid patients and also a known compli- cation with influenza patients. But, Lagrou added, ‘The diagnosis with Covid patients is not easy and it’s good to combine different tests. These patients might also have an invasive Candida infection, especial- ly among those in the ICU. As yet, we are in the learning phase about the incidence, disease characteris- tics, and still evaluating these tests. It is too early to say what the exact value of the ß-glucan test is in this instance.’ However, there are aspects of the Wako ß-glucan test that make it an appealing option for clinicians. The single sample test: a real advantage ‘One of the things that appeal is the fact that you can run it as a single sample test,’ Lagrou said. ‘That’s a real advantage because we are in a setting of several life-threatening infections where it is important to Professor Katrien Lagrou is Head of the Department of Microbiology, Immunology and Transplantation at the University of Leuven and also heads the National Reference Centre for Mycosis. She is also Professor at the Faculty of Medicine of the Catholic University of Leuven. Her major interest is the diagnosis of fungal and viral infections in severely immunocompromised patients, with a focus on invasive pulmo- nary aspergillosis. Lagrou also presides over the Belgian Society of Human and Animal Mycology and is former General Secretary of the European Confederation of Medical Mycology. get the information as soon as pos- sible and to be able to put together the results of different tests we are conducting. It’s also a robust test and the reproducibility is very high.’ Other advantages, she pointed out, are that the test adds additional information, is not difficult to imple- ment or execute, and staff can be trained to use it relatively easily, and it also delivers rapid results with clear benefits for prompt patient care. Lagrou believes there will be future areas where the Wako ß-glu- can test can be of value and this will evolve as the sensitivity can be improved by lowering the cut-off value, with high sensitivity of par- ticular importance when diagnosing invasive fungal infections. Patients with an impaired immune system are at risk of invasive fungal infections we also know the PCR test is super- sensitive and may detect colonisa- tion and not infection, said Lagrou, who also heads the Department of Microbiology, Immunology and Transplantation and also heads the National Reference Centre for Mycosis at University Hospitals of Leuven. ‘If it’s not possible to conduct bronchoalveolar lavage, the ß-glu- can test may be used to evaluate the likeness of Pneumocystis infection. In addition, this test may also be of value in the discrimination between infection and colonisation.’ What it offers as a complimentary test, she added, is an extra level of reassur- ance – either to support a diagnosis or exclude the diagnosis. In vitro diagnostic test ‘The diagnosis of fungal infection is complicated and you need to put together different tests and they all Stabilisation from the start Precise glucose testing Diabetes mellitus is one of the most common metabolic disorders in the world, and plasma glucose levels are essential for its evaluation, as well as gestational diabetes. The breakdown of glucose (glycolysis) in venous blood samples is of great significance in pre-analytics, par- ticularly in relation to the diagnosis of diabetes mellitus and gestational diabetes. Effective glycolysis inhibition: determining in vivo blood sugar content precisely with the Vacuette FC Mix Tube Greiner Bio-One produces the Vacuette FC Mix Tube. This special additive mixture not only reduces the pH value and blocks the pH- dependent enzymes which would be active in the initial stage of the glycolysis cascade. The tube can also stabilise the sample immediate- ly after collection for up to 48 hours. The time from collection until separation of plasma and cells, temperature as well as cell count strongly affect glucose levels, pos- sibly leading to false low results. Unfortunately, fluoride alone cannot stabilise the real in-vivo glucose level completely. Vacuette FC Mix Tubes are citrat- ed and therefore can help to prevent the initial loss of glucose within the first few hours from collection until fluoride shows its effect. Buffered Na2EDTA, citric acid, sodium citrate and sodium fluo- ride are used to decrease the pH and block the pH depend- ent enzymes, which would be active in the ini- tial stage of the glycolysis cascade. The shatter-proof tube is made of polyethylene terephthalate (PET). PET is important for the stability of the vacuum, Greiner Bio-One points out, adding that the safety cap is particularly easy to open and facilitates hygienic working. The transparent plastic label provides an optimum view of the tube contents. Powder additive ‘The powder additive in the Vacuette FC Mix Tube has no dilution effect. There is no need to take a con- version factor into consideration. Inverting ten times ensures that the tube additive is completely dis- solved and well mixed with the sample. than ‘Should the stored tubes be longer 24 hours at room tem- perature, samples should be centrifuged after blood collection. Centrifuged aliquots from FC Mix Tubes can be stored for up to 48 hours at room tempera- ture. Tubes should be centrifuged within 20 minutes after blood col- lection. Cooling of the samples is also suitable for 48 hours glucose stabilisation.’ Details: www.gbo.com EUROPEAN HOSPITAL Vol 30 Issue 1/21

@ ECR W W W. H E A LT H C A R E - I N - E U R O P E . C O M 2021 S P E C I A L I S S U E F O R T H E E U R O P E A N C O N G R E S S O F R A D I O L O G Y O N L I N E E V E N T V I E N N A A U S T R I A M A R 0 3 - 0 7 2 0 2 1 Awareness is key for breast screening services time,” he said. With 3DQuorum, resolution and detection are better, he pointed out. It is an integrated solution that reduces the number of 3D images to review by two-thirds, improves workflow efficiency and can literally take an hour of work off an eight-hour shift. Educating consumers As a global leader within breast health, he underlined Hologic’s commitment to patients and custom- ers during the pandemic. This has seen Hologic reach out directly to patients with educational resources to raise and maintain awareness of the importance of breast cancer screening. In the United States, Hologic launched a “Back-to-Screening” con- sumer education initiative which focused on reminding women of the importance of mammograms and not missing examinations, and how facilities were working to be Covid- safe. In Europe, a similar breast can- cer awareness campaign addressed women directly, but targeted via social media. The European cam- paign will continue in 2021. Another element supports cus- tomers on tomosynthesis breast can- cer screening and products such as ultrasound technologies, hand-held Daniela Zimmermann speaks to Samir Parikh, Hologic’s Global Vice-President (Research & Development and Clinical Affairs), about the company’s approach to raising post-Covid awareness of breast screening. poned has created an additional burden on health systems as they move out of Covid” said Mr Parikh, who has been with Hologic for 24 years and from the start of the com- pany’s digital journey. Addressing the backlog With early detection a critical part of the breast cancer journey, awareness and access to screening are impor- tant messages for women as ser- vices pick up, but he acknowledged patients need to feel “comfortable” about coming back to screening ser- vices. Healthcare facilities are taking precautions, but that is adding to workload and means procedures will take longer. “The biggest challenge,” he con- tinued, “is how do we address the backlog and get back to that routine of annual screening for everybody, not just breast cancer? We believe this is where Artificial Intelligence will play a significant role.” Mr Parikh highlighted how Hologic’s Genius AI™ technology can improve workflow efficiency by enabling radiologists to read images more efficiently and help reduce backlogs. “AI is core of where we are going,” he said. “We believe AI will continue to help how we improve, not only in cancer detection or operational efficiency, but also affecting clinical outcome across the whole pathway.” Digital breast tomosynthesis (DBT) remains a proven technology within the mammography sphere, but having images sliced into 1mm segments in some systems can lead to fatigue with a 5cm area of breast resulting in 50 slices to scroll through. Hologic’s Genius AI solution sees the company’s 3DQuorum™ Imaging Technology, Powered by Genius AI™, create 6mm SmartSlices where each high-resolution SmartSlice overlaps the previous one by 3mm, ensuring there is no loss of 3D image data and continuity in scroll- ing. HIghlighted regions of interest “This not only overlaps, but with the AI underneath we are making sure regions of interest that are impor- tant to a radiologist – lesion, clas- sification, masses – are highlighted and that helps reduce the workflow Hologic’s 3DQuorum technology The impact of Covid-19 has been dev- astating; countless lives lost, millions of infections worldwide, health sys- tems overwhelmed and economies rapidly shrinking. In addition, rou- tine operations have been cancelled, patients have avoided Emergency Departments for fear of catching coronavirus or hampering health workers, and others have failed to seek help when they should have consulted a physician. Health experts fear this is stor- ing up a negative health legacy for years ahead as patients present with worse symptoms than if they had sought timely help. Screening, such as for breast or cervical cancer, is an area particular- ly affected, with numerous appoint- ments delayed. It is against this backdrop that Hologic is working to pave the way for a return to a degree of normality for when the coronavirus pandemic passes. Raising awareness Central to that is a role in raising awareness among women about the importance of breast cancer screen- ing, alongside helping health sys- tems reduce backlogs and restore screening to pre-Covid-19 levels. Within that are also steps to help clinician workflow and offset any increased workload. Samir Parikh has outlined how the company is raising awareness of breast screening with consumer education campaigns, and develop- ing innovations to support clinicians and health systems deliver effective screening programs post-Covid. At present, global health systems have a realigned focus to cope with Covid-19, which is having a signifi- cant effect on preventive screening and will impact future outcomes. He pointed to evidence in the UK that postponement of clinical cancer diagnostics and treatment may lead to 18,000 more deaths over the next year, while a French study found 38% of people avoided screening over Covid-19 concerns, and 28% did not want to further burden healthcare workers. Studies elsewhere in the world reflect a similar picture. “Breast cancer screening, cervical and other procedures being post- Samir Parikh is the Global Vice President of Research & Development. In this role, he is responsible for leading and driving innovative advanced solutions across the continuum of care to drive sustainable growth of the Breast and Skeletal Health division. Samir joined Hologic in 1997 and held positions of increasing responsibility over the years. and surgical devices, with a medi- cal education team established to deliver an educational and technol- ogy support structure. He said: “For us, the biggest learning point from Covid-19 was that it reinforced our commitment to providing insight- driven innovative solutions through- out the patient pathway. It is at the heart of what we do; it is about how we connect the dots from risk to screening, to diagnosis, biopsy, surgery, pathology, and to treatment and how we integrate our solutions for improving workflow and driving critical patient outcomes in a lifesav- ing way.” AI-led technology, he added, can improve efficiencies, reduce cost and burden, and “the impact of the backlog along the entire pathway.” Commitment for women’s health While Hologic has extended its portfolio with the acquisition of SuperSonic, he explained, that it will continue to see its portfolio evolve over the medical spectrum, with AI playing a crucial role but empha- sized Hologic’s commitment to, and core focus on, women’s health. Having structured the company’s innovation – internally, organically and through acquisitions – under- lines a sharp focus on the global pathway. “But this is just the starting point. Our goal is to impact a billion women in the coming years and we will not be able to do this unless our mission and purpose is very focused,” he concluded. “Hologic remains a leader in breast health and our commitment to that through innovation and technology remains our primary focus.” EUROPEAN HOSPITAL Vol 30 Issue 1/21

8 E H @ E C R The iCAIRD project – evaluation and the route to adoption AI to aid Scottish breast screening Implementation of artificial intelligence into Scotland’s national breast screening service is moving closer following an initial success with a trial project, Mark Nicholls reports While Scotland’s breast screening trial has delivered highs and lows, signif- icant hurdles have been overcome in terms of approvals, governance and patient acceptance. The ongoing process of bringing AI into the mam- mography programme was outlined at the virtual Artificial Intelligence in Practice event organised by the British Institute of Radiology, in association with the Royal College of Radiologists. is also Lip, who In his presentation ‘Experiences with mammography AI evaluation, analysis and route to clinical prac- tice in the iCAIRD (the Industrial Centre for Artificial Intelligence Research in Digital Diagnostics) pro- ject’, Dr Gerald Lip, Clinical Director of the North East of Scotland Breast Screening Service, outlined how AI is being lined up as an independent reader of mammograms in Scotland. the Chief Investigator of the Mammography AI project as part of iCAIRD, explained that the process began in November 2018 with an Innovate UK grant, with contracts signed and data pro- cessing and information agreements set up as the partnership involving Kheiron Medical and Canon, the University of Aberdeen, National Screening Services in Scotland and NHS Grampian took shape. ‘Most of 2019-20 was spent on physical infrastructure, getting permissions, meetings, satisfying information governance and building a virtual workspace for anonymising 80,000 mammograms from over four years in the North East of Scotland,’ Lip explained. With the Scottish breast screening system already paperless, the data Mammography images being viewed as part of the iCAIRD project to implement AI into the Scottish breast screening service. p i L d l a r e G © was readily available in a highly- structured data extract and trans- ferred into the ‘safe haven’ for the project. Work progressed well in 2020 despite Covid, from Phase 1 of establishing feasibility and proto- type, and into Phase 2 of develop- ment and clinical evaluation, clinical efficacy and safety data, with the project expecting to submit its first scientific papers. Entering Phase 3 With the Scottish breast screening sy The project is now set to enter the Phase 3 stage of real-world testing, subject to research grants looking at the feasibility for implementa- tion across multiple sites, regula- tory approval, working through the health economics and subsequently into Phase 4 with initial health sys- tem adoption. ‘Phase 3 is the hard divide,’ Lip pointed out. ‘In a clean retrospective analysis in Phase 2 you can get good results but moving into clinical prac- tice is a different story, especially in screening, because we are looking at evaluating this as an independent first or second reader.’ He also explained that the data used in the evaluation stage was not curated or enriched and covered four years with over 80,000 women, 240,000 images, and 700 cancers. As the project team knew what was there, they were keen to see what conclusions AI came to. 80-90% of women accept AI Patient engagement has been important and positive with patient group surveys on women’s attitudes to AI in screening mammography. ‘In our population, 80-90% of women were very happy to have AI read their mammograms, particu- larly if a radiologist was involved,’ Lip reported. ‘Women who had an understanding of AI were more accepting of AI and if they could get results back faster, but safely, they were very happy with that process.’ Engagement with stakeholders such as the Scottish government Gerald Lip MD MSc is Clinical Director of the North East of Scotland Breast Screening Service, the Chief Investigator of the AI mammography project and an honorary senior clinical lecturer at the University of Aberdeen. He is a graduate of Trinity College Dublin where, along with his medical degree, he gained an MSc in Health Informatics. and national screening services and research, advisory and governance bodies was a critical, yet time-con- suming, step. ‘I’ve probably spoken to or corresponded with 40-50 dif- ferent committees in the last two years, trying to put away miscon- ceptions about AI. You find there are people in a different place to you and not all these groups were in perfect agreement,’ Lip reflected. ‘Covid was also an issue; there was a lot of prioritisation of Covid-based projects and suspension of non- Covid projects. ‘We had ups and downs, but there were some highs: after six months of getting permission to move the anonymised data from 80,000 women into our safe haven, it was done over a weekend with- out affecting the network. Similarly, when we ran our first results trial for the AI project, it was 240,000 images in two days.’ The Scottish government has been supportive, as has NHSX, which has responsibility for setting national policy and developing best practice for NHS technology, digital and data. The project is now checking validation and clinical evaluation of the AI algorithm to ensure there is no bias as they look to moving into real-world practice. Lip explained that, in breast screening, the usual cancer detec- tion for a single reader is 6-8 can- cers in 1,000 mammograms, whilst two radiologists combined may find 10-12 cancers. ‘The idea of AI, when it’s replacing a reader, is not to be the same as the average reader but to be as good as an experienced reader,’ he added. To move this forward into the Scottish breast screening system, the iCAIRD project team is designing a training module with AI integrated into it, that will read opinions and compare with expert readers. This is planned to be rolled out across six centres covering 20,000 mammo- grams a month to deliver ‘granular level of understanding’ of the data in the platform. technology The data training module, he explained, will act as a form of health assessment, rather than a formal randomised controlled trial, which will help the decision-makers and regulatory authorities to determine whether this can be adopted into the breast screening programme. Questions remain about IT, data protection agreements, the use of the cloud and how screening read- ers get feedback on performance, but Lip is optimistic that, over com- ing months, the AI project will move closer towards implementation in the Scottish breast screening pro- gramme. Managing cancer breast lesions Report: Cynthia E. Keen The management of biopsied breast lesions that are diagnosed as abnor- mal but are not definitively malig- nant is challenging and controver- sial. Treatment ranges from diligent follow-up, with imaging and subse- quent biopsy, to surgical excision. Researchers at the Medical University of Vienna (Medizinische Universität Wien), Austria, have developed and validated a software algorithm designed to stratify the risk of a breast lesion of uncertain malignant potential, known as a B3 lesion. This could help define the best treatment or follow-up and pre- vent unnecessary surgeries. Because B3 lesions have an increased risk of malignancy and an increased risk of subsequent development of invasive breast cancer, the practice in many countries is surgical excision. Thus, many women with ulti- mately benign lesions have unnec- essary surgeries. Additionally, with a steadily increasing number of B3 lesions being diagnosed by biopsy, due to improvements in mammog- raphy imaging and the worldwide increase in breast cancer screening programmes, more precise meth- ods of predicting malignancy are needed. Currently, the risk of missing a malignant component in a B3 lesion ranges from 2-58%. Writing in the February 2021 issue of the European Journal of Radiology, the researchers attribute this wide range to characteristics of the type of biopsy performed (core needle or vacuum-assisted); the lesion type; and diverseness of imaging features, which include microcalcifications, masses, and architectural distor- tions. The researchers advise that B3 lesions are identified in 3-11% of stereotactic-guided vacuum-assisted stereotactic biopsies (VABB) per- formed for suspicious microcalci- fications. Their aim was to create a machine learning risk stratifica- tion method for VABB diagnosed B3 lesions using a combination of imaging, pathological, and clini- Two cases that underwent stereotactic vacuum-assisted br calcification. Case A (perimenopausal woman) revealed flat epithelial hyperplasia, histopathological examination, no history of breast cancer to the risk stratification algorithm. Follow-up instead of sur was proven. The postmenopausal woman in case B was r cancer on in the right breast. The microcalcification cluster shown was found and biopsied in the left br revealing atypical ductal hyperplasia. This intermediate risk lesion was discussed in the multidisciplinary meeting and surgery suggested, revealing an invasive ductal cancer G2. EUROPEAN HOSPITAL Vol 30 Issue 1/21 we make it possible

1 0 E H @ E C R Viewing through a ‘window’ empowers management How to shape a blueprint for progress Hospital data from a wide range of disciplines, departments and specialties strongly influences crucial decision-making and planning. Agfa HealthCare’s Business Intelligence solution, for example, uses data to measure, understand and predict developments, and aims to present this information in an accessible and transparent way so that administrators need not even ask for in-house generated reports. Agfa’s Business Intelligence product manager Tommy Vansteenkiste, and Willy Rosé, representing Agfa’s Imaging IT solu- tions marketing division, discussed the firm’s solution with Mark Nicholls. waiting times to see if there are peaks that can be flattened to provide a bet- ter patient experience, and how fast a report is delivered to the ordering physician,’ he added. ‘It’s about ensur- ing the operation runs smoothly, and also keeps a quality of service.’ Benefits can be measured in many ways, such as time efficiency and tracking how long it takes to provide a service, whilst also offering a check- point on a system’s quality. Here, identifying peaks and supporting changes in the scheduling and plan- ning of examinations, for example, can improve treatment delivery. More Agfa HealthCare’s Business Intelligence solution recently, the solution has tracked the growth of coronavirus and associ- ated changing service demands and delivery. ‘What we are seeing is where there are dips in certain procedures and those coming back in again. That can give input on resourcing and what is coming up and what a hos- pital might need to plan and change,’ Vansteenkiste pointed out. facet Diving into something strange A key is how Business Intelligence allows users to explore the data in detail. ‘The end user can explore data and add certain attrib- utes or “slice and dice” the data in a different way,’ he explained. ‘Often, There is a solution that amalgamates all hospital data – e.g. involving per- sonnel, equipment, patients’ waiting times, room occupancy, age groups and regions from which they have been referred, workflows and bot- tlenecks, and the use of an imaging device (e.g. if one CT scanner is used more than another, indicating further equipment investment). The solution reveals multiple aspects of the organi- sation, helping to streamline opera- tions and processes, accreditation, capacity and investment planning. It also monitors trends and helps with billing accuracy and quality improve- ment. Vital assessments during the pandemic This ability has proved particularly important during the coronavirus pandemic, during which assessment of workflow, capacity, and perfor- mance has been and is crucial. As Business Intelligence prod- uct manager Tommy Vansteenkiste observed, ‘The solution brings data to the fingertips of the end user.’ A department head can identify where there is room for improvement, view market information, assess a shift in the use of certain equipment, or where investment is needed. Clinical staff can also assess workflow, perfor- mance and future workloads. ‘It helps with resourcing and planning, patient After a 15-year engineering career at Agfa Gevaert, Willy Rosé transitioned to the role of Head of Marketing IT Europe at Agfa HealthCare. Leading a team of 10 highly skilled professionals, he connects the dots between regional sales organizations, R&D, finance and solution management. you do not know what you are look- ing for until you see it. The whole point of Business Intelligence is that you see something strange and dive into it and look what the issue is. We are not only giving the data more to the end user, but we are enabling them to explore the data.’ Willy Rosé, from Agfa’s Imaging IT solutions marketing arm, confirmed that the tool’s value lies in identify- ing areas that need improvement and where problems lie. ‘You can use it to mine the data, see where a prob- lem is; fix or improve, and measure again.’ He further outlined the solu- tion’s capability to focus on human performance. ‘If you can measure how many duplicate examinations you do, you can investigate if it’s because of equipment, people, or the process and, by doing that, you can Tommy Vansteenkiste joined Agfa HealthCare in 2004 as part of the IT R&D department and has been active in differ- ent roles in both R&D and Global Services. Currently he is Product Manager for Enterprise Imaging’s Business intelligence solution bringing actionable insights to Medical Imaging providers. increase operational efficiency and avoid unnecessary examinations. That is where Business Intelligence comes together with clinical intelligence.’ Identifying staff who need support If the analysis system reveals that some personnel take longer to per- form a task, this may suggest a need for support, or question whether the workload is being effectively distrib- uted across devices – for example, not overloading CT scanners. The Agfa Business Intelligence solution is also a powerful tool in terms of monitor- ing performance; producing reports for accreditation and documenting improvement, and measuring patient and referrer satisfaction. In a nutshell: The solution aims to transforms data into actionable insights leading to more informed decision-making and improved opera- tional efficiency. With easy access to all operational data and reports, it can help to detect productivity gaps, maximise modality utilisation, and optimise resource utilisation and per- formance. As Rosé summed up: ‘The Business Intelligence system is a win- dow on a hospital’s data, workflows, and performance.’ Images and patient data combined Integrated radiogenomics improves clinical outcomes Harnessing radiomics power and adopting an integrated way to com- bine imaging and patient data could improve cancer outcomes. Now, clinicians can explore a non-invasive method to identify the heteroge- neity of a tumour and more accurately target regions for biopsy. During a presentation at ECR 2021 in March, Professor Evis Sala will underline the importance of inte- grating data to build a clear, non- invasive diagnosis and potentially cut down on the need for biopsies, as imaging and radiomics builds up a clear view of a lesion. Her current research focuses on integrated diagnostics through the clinical development and validation of functional imaging biomarkers to rapidly evaluate treatment response using physiologic and metabolic More than just MRI accessories www.allmri.com tumour habitat imaging. Sala’s pres- entation, ‘Linking radiomics features to other omics data in clinical prac- tice’, will review potential applica- tions of emerging radiogenomics, and discuss how to analyse big data. The Cambridge team com- bines multi-layered data – radiomics, clinical, and blood data (CA 125 in the case of ovarian cancer) – with e-genomics, including circulating tumour DNA, and patients’ history, to develop algorithms to predict treatment response. Robust data to create a robust biomarker Underlining the need to have robust data to create a robust biomarker, Sala’s examples will concentrate on CT scan and ovarian cancer. She also emphasises the importance of keeping the research grounded in everyday practice, to ensure the developed biomarkers actually will be useful in the clinic. A challenge lies in making the transition from qualitative research and data to quantitative findings and turning that image data into num- bers. ‘That’s not going to be pretty to the eye,’ she acknowledged. ‘As radi- ologists we are visual, but we have to extract things we don’t see with our bare eye because that’s where the quantitative information is.’ Sala, whose work integrates quan- titative imaging methods for evalua- tion of spatial and temporal tumour heterogeneity with genomics, pro- teomics and metabolomics, points out that the additional features to acquire the quantitative informa- tion rely on heterogeneity, which is imperceptible to the human eye. ‘It might not be exciting to radi- ologists, but it is so crucial to feed that information into the algorithms that can actually predict response and outcome.’ To extract the quantitative features from an image, the first major step is to segment the lesion. Whilst labori- ous in metastatic disease, this has led to the development of automatic segmentation. Once the lesion is segmented and the radiomics data extracted, it is fed into the treatment prediction algorithm with other clin- ical and molecular data. Her team is working on the use of this tool to create a ‘virtual biopsy’ to reduce the number of biopsies needed, by more precisely targeting the optimum site EUROPEAN HOSPITAL Vol 30 Issue 1/21

1 2 E H @ E C R Portable ultrasound demonstrates versatility in all specialties Covid-19 – Testing time for people and devices which is easy to use and is respon- sive, even with gloves and gel. It can also connect seamlessly to the hospital’s electronic patient record (EPR) system. With a wide range of pre-sets to cover all POC exams, the device has full calculation packages included as standard. Three transducers can be connected at once with easy on-screen selection; there are 23 probes available ranging from 1 to 20MHz for high-definition imaging, and the machine boots up in less than 25 seconds, or three seconds from standby. At UMC, the TE7 is used in the recovery ward and to perform echo on patients’ lungs, heart and abdo- men. Also, should a patient need an emergency operation, it can be used to check whether the stomach is empty, or not. ‘We use a mobile machine because we do not have enough ultrasound devices to go around the 23 theatres we have, which are also on separate floors of our hospital,’ de Roos-Baron explained. Careful logging of equipment keeps track of where on site the five Mindray machines are at any time. Another advantage is that the device can last for 1-2 hours on Dr Karina de Roos-Baron at work battery, and then be plugged in or re-started promptly when needed. This is a robust machine – particu- larly important in the Covid envi- ronment where constant disinfec- tion is necessary – and it is easy and straightforward for ICU and theatre staff to cover the machines, the flat screen, and the probe with plastic protection. ‘What’s changed during Covid is that there is a lot more disinfection of machines,’ de Roos- Baron pointed out. This is in addi- tion to the constant use by staff of PPE and the time taken to put that on. While the theatres are working at reduced capacity, the ICU is very busy with Covid patients and, at UMC, additional ICU space has been created, with older wards reopened, re-purposed and re-equipped for coronavirus patients. Covid patients are also being treated on general wards, but can be moved to ICU if their condition deteriorates. In a nutshell, the benefits of the Mindray TE7 have become increas- ingly apparent to UMC staff during the coronavirus pandemic due to their mobility, performance, flexibil- ity and reliability. ‘In the beginning, I was sceptical, but we are pleased to have them,’ the UMC anaesthesi- ologist concluded. ‘As the person in charge of them, I think this is a very good machine.’ Due to the coronavirus, hospitals and medical staff developed new work practices involving, in acute settings, social distancing, rigid use of per- sonal protective equipment (PPE), handwashing, and disinfection of equipment every day. Additionally, portable, highly- mobile and versatile equipment came to the fore in point-of-care (POC) – particularly when wards and operating theatres are spread across several floors and access to specialist devices is at a premium. This proved the case in operat- ing theatres, wards and intensive care units (ICUs) at the Utrecht University Medical Clinic (UMC) in the Netherlands, where port- able ultrasound has supported swift and effective diagnosis of Covid-19 patients and supported treatment pathways. Anaesthesiologist Dr Karina de Roos-Baron, who works across the ICUs and operating theatres at UMC, said that during the second wave of the pandemic cases, and deaths remain high, with extra ICU beds opened up to cope with increasing numbers of Covid-19 patients. Here, ultrasound is playing a vital role. With wards and operating thea- tres spread across two floors at UMC, and not every unit having an ultrasound machine, the five highly portable and versatile Mindray TE7 machines are proving to be real workhorses. Elective surgery has been cut by half as operating theatre staff are redeployed to care for Covid-19 patients, meaning the portable TE7 is playing an increasingly important role. ‘This is a very mobile unit,’ de Roos-Baron confirmed. ‘It’s available at point-of-care, does not need a constant energy supply and is easy Anaesthesiologist Karina M M de Roos- Baron heads the regional anaesthesia working group at University Medical Centre Utrecht (UMC), the Netherlands. After completing medical school in Amsterdam, she gained experience in anaesthesiology and intensive care as a resident and fellow at the UMC and other Dutch hospitals. Keen to educate new staff, Roos-Baron is an instructor for the Acute Trauma Life Support (ATLS) train- ing programme as well as for the Dutch Association of Regional Anaesthesia (DARA). to disinfect. In the operating theatre, we use it for venous and arterial canulation and, in ICU, for vascular access.’ The hospital’s five Mindray TE7 systems are also being used by col- leagues in, for example, neurosur- gery, vascular surgery and urology. Also, with a programme starting for POCUS (point-of-care ultrasound), that role is set to expand further. The TE7 offers superior image quality, simple touchscreen opera- tion and intelligent tools to help speed up ultrasound examinations in demanding POC environments such as critical care, emergency and anaesthetics. It features a 15-inch high-resolu- tion anti-glare touchscreen display EASY ON PATIENTS EASY ON PATIENTS AND THE BUDGET. AND THE BUDGET. Accutron CT-D The diagnostics specialist. Quickly ready The diagnostics specialist. Quickly ready The diagnostics specialist. Quickly ready for use, intuitive to operate and self- for use, intuitive to operate and self- suffi cient thanks to latest battery technology. suffi cient thanks to latest battery technology. Hauptstrasse 255 · 66128 Saarbruecken · www.medtron.com Pan-European lung cancer screening Report: Mark Nicholls Pan-European lung cancer screening is challenged due to the range of approaches in different coun- tries. As attitudes towards smoking and smoking cessation programmes vary, experts are attempting to establish more unified lung cancer screening. The introduction of consistent pan-European lung cancer screen- ing will be outlined at a special session during the online ECR 2021, with presentations highlighting the current position in several countries. The session, entitled ‘Lung can- cer screening implementation in Europe: where are we now?’ will be chaired by Dr Annemiek Snoeckx, from the Department of Radiology at Antwerp University Hospital and the University of Antwerp in Belgium. With lung cancer causing 1.76m deaths a year worldwide (5,726 deaths a day), she will look ini- tially at the pivotal aspects of a lung cancer screening service, focusing on the 10 key points of eligibility criteria (who should be screened), plus shared decision-making; image acquisition; imaging review; good communication; smoking cessation; a multi-disciplinary approach; qual- ity assurance; cost effectiveness; research and Artificial Intelligence. ‘From there,’ Snoeckx said, ‘the session will focus on the strug- gles different countries encounter in the implementation of lung cancer screening. I think the biggest prob- lem now in Europe is that there are not yet any European recommenda- tions.’ Welcoming the recent move to include lung cancer screening in Europe’s Beating Cancer Plan, she gave a prediction. ‘I think one of the conclusions from the session might be that different countries have dif- ferent problems because they have different healthcare systems, but that there also are challenges that EUROPEAN HOSPITAL Vol 30 Issue 1/21

1 4 E H @ E C R Agfa’s SmartXR AI gives the digital radio- graphy workflow a boost · SmartDose uses 3D machine and more consistent projections. vision to determine the thickness of the patient, and then tailors the exposure parameters. This helps the technician to speed up the configuration of exposure settings, reduce retakes, improve image consistency, and ensure the ideal dose for the patient. SmartXR Assistant X-Ray Intelligence at work that are available for use with Agfa’s DR 600 and mobile DR 100s1. Defining what hospitals want from AI “The original ideas for possible features came from my time as an image processing researcher, work- ing with X-ray equipment in the lab. I found that I made a lot of mistakes and realized AI technology could potentially help me to avoid some of them,” Gert Merckx explains. To select which features to include in SmartXR, Agfa went directly to radiology managers and users. “We started by conducting customer workshops and data mining our workstation usage patterns to evalu- ate radiographers’ pains and needs. We found the greatest interest was in AI tools for optimising dose, improving positioning, and avoiding the nuisances that drive inconsistent imaging.” Based on these findings, Agfa developed SmartXR, which current- ly includes four sets of AI features SmartXR at a glance · SmartPositioning augments a live camera stream of the patient by projecting the image area and the AEC X-ray feedback sensor positions onto the patient’s body. This helps the technician speed up positioning, while making it more accurate and consistent to reduce retakes. · SmartRotate uses deep learning to auto-rotate images to their standard orientation based on the image content. Fewer post- processing actions are needed, while image presentation on both workstation and PACS is more consistent. · SmartAlign uses advanced sens- ing to give live feedback on the accuracy of the tube-to-pan- el alignment during bedside or out-of-bucky exams. Alignment is faster and more accurate, with fewer retakes due to grid cutoff Two SmartXR packs are available: the Convenience Pack includes SmartRotate and SmartAlign; and the Performance Pack includes the full set of intelligent features. An assistant, not a replacement The role of the tech- nologist in radiol- ogy is critical, not only from a technical standpoint but also from the perspec- tive of their i n t e r a c t i o n s with patients. “SmartXR is not intended to replace the tasks of the technicians, but rather to assist them in completing those tasks. It can help a less experienced technician to avoid errors, while lightening the workload for a more experi- enced technician. The technician remains in control – all the time,” describes Gert Merckx. “But a ‘help- ing hand’ that supports the work- flow reduces stress for both radiog- rapher and patient.” At ECR 2021, Agfa will introduce SmartXR to NEW: The CL-S1200 colour 30.9-inch monitor the European radiology field. Gert Merckx explains, “With SmartXR, we have given our imaging solutions eyes and a brain, we’ve made them aware of their environment and we have taught them their first skills. We are only bound by the limits of our imagination now.” 1 SmartXR SmartDose and SmartPositioning on DR100s is a work in progress. Contact your local sales representative for more information on the availability on the SmartXR tools in your region. Liv, the friendly face of Agfa’s SmartXR Imaging workflow assistant Control via PACS Another new feature of the CL-S1200 is the ability to control the display directly from the picture archiv- ing control system (PACS). JVC has developed and integrated a special interface to do this. ‘It allows the user to start the Visual Point Mode, for example, from within his famil- iar working environment and with- in the workflow. This darkens the areas outside the region of interest and enhances the contrast within,’ Herrmann points out. In addition, the presets, i.e. the defined default settings of the display for certain images, can also be switched from the PACS. ‘In doing so, the PACS transfers the respective DICOM tag to the MS-S1200, which then selects the appropriate pre-set,’ he explains. If a mammogram is to be found, the monitor would work with a bright- ness of 500cd/m², and with a CT scan with only 250cd/m². Sanitation Additionally, the smooth, flat design of the CL-S1200 ensures that both the monitor and the wide-angle swivel can be disinfected and thus maintain hygiene. Details: http://healthcare.jvc.com EUROPEAN HOSPITAL Vol 30 Issue 1/21 In the move to evidence-based medi- cine, healthcare budgets put more pressure on efficiency, while quality of care has to meet ever increas- ing standards. Agfa has chosen to direct its development of artificial intelligence (AI) solutions towards helping radiology departments meet these challenges. Agfa’s SmartXR AI upgrades for its digital radiography portfolio focus on supporting operational efficiency and clinical consistency, as Gert Merckx, Product Manager Radiology Solutions for Agfa, explains. An ‘intelligent’ approach to doing more with less “Eliminating waste, supporting quality care, and enabling an effi- cient workflow are certainly not new challenges! With our legacy in imaging going back 120 years, we have worked hand-in-hand with our customers to enable continuous improvements. But AI technology allows us to completely rethink the equation,” begins Product Manager Merckx. He continues, “One of the most pressing challenges for managers of imaging departments is a short- age of skilled technicians com- bined with more limited training on radiography. This raises problems that impact departmental quality and efficiency, including avoidable errors, high exam variability, and more.” Agfa is addressing these issues with SmartXR, which adds targeted AI-based features to its DR solu- tions. SmartXR acts as an ‘intelligent assistant’ to the technician, enabling a smoother and more efficient daily imaging workflow and more con- sistent images. Displaying medical images of different modalities, such as CT, CR/DR, MR, ultrasound or mammography and pathology, on one screen? That’s a radiologist’s dream – indeed, many place several medical displays side by side to see several scans at the same time. With its new 30.9-inch CL-S1200 colour monitor ,JVCKenwood has eliminated this awkward practice. With 12 megapixels (4,200 hori- zontal and 2,800 vertical), the device can display a variety of medical images side by side. The windows arrangement can be freely selected, and the large screen, without a cen- tre bar, creates a comfortable envi- ronment for radiological diagnostics. With a maximum brightness of 1200 cd/m² and contrast ratio of 1500:1, the monitor is also suitable for mam- mography. The CL-S1200 colour 30.9- inch monitor Analysing several scans on one screen succeeds even with moving images without any problems, although millions of operations per second are necessary here,’ explains Marcel Herrmann, Marketing Manager of Medical Imaging at JVCKenwood. Latest technology integration The display contains the latest technology. The patented Dynamic Gamma function, for example, analy- ses the entire screen content and selects the correct gamma curve for each individual pixel in real time. This applies to all images, whether ultrasound, endoscope, pathology or nuclear medicine, and always pro- vides an optimal representation. ‘This The innovative Turbo Luminance function can increase the bright- ness and contrast of the screen for a maximum of 30 seconds to magnify recognisable gray scales, the manu- facturer reports. ‘This allows radi- ologists to reliably assess even low- contrast lesions on mammograms. The effect is further enhanced by the Visual Point mode. ‘Luminance and colour tempera- ture are automatically adjusted in real time on the CL-S1200. The built- in colour front sensor on the screen constantly measures colour tempera- ture and adjusts changes over a long period of time,’ Herrmann explains. This is gentle on the examiner’s eyes – as is the built-in illumination on the back of the monitor and the indirect illumination of the keyboard and mouse, the company confirms.

1 6 D I G I TA L PAT H O LO G Y Multiplexing, DNA/RNA sequencing and AI applications An exciting new era for tissue microarrays A new generation of tissue microarrays are delivering more efficient, time-effective solutions to answer complex clinical and scientific questions, digital pathology allows specific and targeted analysis of small areas of tissue. During an online presentation of the 7th Digital Pathology and Artificial Intelligence congress, Professor Inti Zlobec outlined advances ‘From artificial intelligence to multiplexing: exciting avenues for next-generation Tissue Microarrays’. As of Head the Translational Research Unit (TRU) at the Institute of Pathology, University of Bern, Switzerland, Zlobec explored the potential of an approach pioneered through her unit’s development of next-generation Tissue Microarray (ngTMA), and looked at the benefits of coupling with digital pathology in translational research. A virtual goldmine The TRU has assembled a massive repository of pathol- ogist-annotated images through the ngTMA Facility, including whole slide and tissue microarray spots, linked to corresponding clini- cal and histopathological data, to create what the team described as ‘a virtual goldmine for training machine learning algorithms’. ‘Exciting new avenues for inves- tigation using tissue microarrays include multiplexing, DNA/RNA sequencing and artificial intel- ligence applications,’ she said. Underpinning their research at the Institute is the Tissue Bank Bern (TBB), a platform on which their collections of different tissues are used and stored for different stud- ies and analysis. This includes a frozen collection of 12-13,000 differ- ent tissue samples stored at -80°C. Outlining the evolution of TMAs from the late 1990s, Zlobec pointed to the benefits of having tissue cylinders in one block, making it easier to identify an area of focus. ‘It’s an incredible tool because they are easier to evaluate and it’s a research tool lasting years, depend- ing on the quality of the associated clinicopathological data. They create the same experimental conditions TMA of breast cancers with brain metastasis but with less resources and less material.’ Her group has focused on a subgroup of cells in colorectal cancer (CRC), called tumour buds, which are heavily related to CRC prognosis. ‘Tumour budding appears in many, or most, solid cancers and is a route to dissemination and metastasis,’ she added. ‘We wanted to capture these tumour buds and study them in terms of heterogene- ity of biomarkers. This would have been impossible using old TMA techniques because there is no guide to punch out very spe- cific areas. However, the way to do that would be to use a digital slide.’ That enables researchers to mark certain areas of interest and placing annota- tions on an image. ‘It is a digital pathology- based solution and works with annotation of a scan and align- ment with a block and creates beautiful TMAs,’ she pointed out. The ngTMA process is about con- structing a TMA that is very specific for the research project and, by using digital pathology as the basis, more questions can be answered. They can be used for pre- tumour cision medicine, rare dis- heterogeneity, eases/scenarios, to target histological areas, perform animal studies, and establish antibodies and new methods. Identify patients who will benefit most Examples include PD-L1 in colo- rectal cancer, to identify patients who will benefit most from immu- notherapy and the use of ngTMAs to answer the question about PTEN deletion, a known major cause of PTEN protein loss, correlating with aggressive characteristics and worst outcome. In addition, ngTMA has been used to compare the pro- tein expressions for breast, brain and pancreatic cancers. Future trends in ngTMA include multi- Inti Zlobec is professor and head of the Translational Research Unit and the Bern Tissue Bank at the Institute of Pathology, University of Bern, Switzerland. She leads the digital pathology project for rou- tine diagnostics as well as the colorectal research group which develops computa- tional approaches to address clinical questions. plexing, DNA/RNA sequencing and AI. Multiplexing can be expensive; scanning – and analysis – can be time consuming, but can lead to increased precision due to smaller areas/cores on which to concen- trate. ‘Scanning time can be avoided if you have a smaller number of slides,’ Zlobec explained. ‘One of the examples of multiplexing that we have helped to contribute to is CODEX, the application in co- detection by indexing.’ With colon cancer, the researchers plan to look at two different special types of immune cell infiltrates and investigate cellular neighbourhoods to orchestrate antitumoral immu- nity in CRC, processes that would not be possible using regular TMA processes. The ngTMA process also facilitates quality control, traceabil- ity and can support image analysis. With AI, the biobank offers a massive repository of images for machine learning and is a huge resource for training algorithms, though the challenge remains over management and efficient retrieval of the data. ‘TMAs are a highly valuable biobank collective,’ Zlobec con- firmed. ‘While useful for convention- al reasons, such as screening of bio- markers, they have an application in the new areas of multiplexing, genomic analysis and computational pathology.’ (MN) Every operating theatre is different - and we are prepared for it. In addition to technically and hygieni- cally high-quality wall-mounted consoles, operating theatre field monitors and all-in-one computers, we offer a scalable software suite that allows us to implement customized solutions for the medical IT sector. Our team integrates research and development, production and sales, project planning and service under one roof. With over 20 years of experience in the medical market, we stand for quality, innovation and reliable service. reinmedical.com The future of digital pathology is assured techniques, unfortunately, being less equipped with diagnostic the results are delayed diagnoses which, in turn, are associated with increased morbidity and mortality rates. The digitisation of pathology resources opens the door for the use of the massive potential of AI in pathology, which can speed up more accurate and reliable diagnosis. Additionally, integration will help to ease large data storage and predict the future outcome of disease, as well as per- sonalise care plans for each patient, and forecast oncology trends par- ticular to specific geographies. In this way, pathologists could suggest proactive approaches to prevent dis- ease progression. Thus, AI-enabled digital pathol- ogy use will transform the horizon of pathologists’ traditional clinical practice, which has been unchanged for many decades. The rise of the pandemic that penetrated the globe without discrimination, further enhanced the need for telepathol- ogy, which I and other pathologists belonging to my organisation use to send digital images to senior col- leagues in hospitals in Karachi to avoid unnecessary travel and expo- sure. However, the bottleneck in Continued from page 15 most of our setup has been the lack of pathology slide scanners or digital microscopes through which WSI can be sent easily. So, the idea of ‘working from home’ through devices emerged, which resulted in new norms in the thought process of pathologists, even in Pakistan, and will leave its impact even after the pandemic completely resolves. Additionally, an important and serious issue in digital pathology adoption is that a large number of technical, ethical and legal questions still need to be answered, particu- larly in developing countries with a weak monitoring system. A very important issue, which may not be a very big deal for developed coun- tries, is the high cost of scanners and AI-based software – among the reasons for delayed adoption of low resource setups and countries. That accounts for the delayed adoption of this novel technique in our area of the world. We sent the cases for second opinion in the form of digital images that we took through microscope cameras, which cannot produce a detailed image; so a second opinion is not always easy. Many times, senior pathologists ask us to come to their location because digital images are not enough to give a reliable consultation, particu- larly in difficult cases. So, due to the lack of scanners and digital micro- scopes, we have used digital images largely for research and educational purpose, not for routine clinical diagnosis. The role of world leading organi- sations of slide scanners and of AI software could be of great impor- tance. They could participate with pathologists and technical staff in developing countries, which are potential sources of big data, in terms of training, as well as to offer scanners, digital microscopes and software at a relatively affordable price, i.e. to put them within the budgets of low resource organisa- tions. Finally, I will conclude on the note that digital pathology and AI is in the forefront of modern pathology and its emerging use within health- care is now being realised. The novel technology is at our doorstep and it is better to welcome and accept it, otherwise a large proportion of the world population will suffer. EUROPEAN HOSPITAL Vol 30 Issue 1/21