As digital pathologies take centre stage, pathologists, clinical experts and technology providers look for untapped opportunities. But, this also calls for standardisation and accreditation of digital pathologies
Clinical pathology has played a significant role in maximising the effectiveness of healthcare delivery for several decades. While pathologies in the past have relied on the conventional microscopic methods, there is a sudden change in its methodology and processes. These changes are driven mainly by the emergence and advancements in digital technologies, pushing the field into becoming more efficient and scalable. The benefits of which can be mainly characterised by improvements in patient safety mechanisms, up-gradation of diagnostic workflow and enhancement in over-all service quality. It also makes the field more business-like, the specimen more reproducible and the work of pathologists less cumbersome. Experts call it the era of digital pathologies, wherein simple image acquisitions have now advanced to whole slide imaging (WSI) also referred to as virtual microscopy. The clinical usage of WSI ranges from telepathology for primary diagnosis to second opinions, remote interpretations of frozen sections and viewing immunostains for showing slides at tumour boards. Various publications have shown a good diagnostic concordance between WSI and glass slides. Moreover, these technologies have demonstrated an increase in productivity of pathologists by 10 to 15 per cent, thereby improving the overall efficiency of healthcare providers. So let’s understand the significance of digital pathologies in today’s healthcare clinical environments.
Digital pathologies changing the status quo
Interestingly, the momentum for the clinical deployment of digital pathology has reached a level where primary diagnostic use of whole slide imaging is no longer a distant future. The global digital pathology market size is expected to reach $ 1.67 billion by 2026, according to a report by Grand View Research. It is anticipated to expand at a CAGR of 11.7 per cent during the forecast period. Therefore, driven by the need for more accurate testing and efficiencies in workflows, shortage of pathologists in the country and the demand for faster diagnostic tools for chronic diseases such as cancer, digital pathologies will soon become the new norm in India too.
In India, the pathologist-patient ratio is highly skewed, doctors face enormous time pressure and have to examine a staggering amount of information to make treatment decisions, for every single cancer patient. Also, being a complex area, the skill and experience of the pathologists make a noticeable difference to the interpretation and patient results. The relevance of such pathologies is, hence, determined.
Speaking about the transition in India, Dr Ajay Phadke, Centre Head, Dr Avinash Phadke Pathology Labs, explains, “India’s deep affinity for technology reflects in the rampant use of screens and mobile devices across the country. It is no wonder that there is a positive connotation associated with technology in medicine as well. Moreover, as the years pass, the cost of manpower will increase, leading to higher company expenditure to attract and retain employees. With time, there will be more pressure on smaller laboratory ventures to increase productivity by acquiring technology to stay competitive. The most important side of technology adoption is to deliver a faster and advanced diagnosis. With around 70 per cent of medical treatment dependent on diagnostics, it becomes imperative for the industry players to consistently provide accuracy in a timely manner. And technology will serve as a critical enabler to deliver quality healthcare support to patients as well as clinicians. Consolidation of healthcare larger metro cities and tier 1 cities is inevitable. This will be fuelled by more automation, point of care devices and higher accessibility by providing services in the patient’s home environment.”
Adding to this, Dr Rajesh Kewalramani, Consultant – Medical Microbiology and STIs/HIV, expresses, “One of the opportunities is to improve turnaround time to results—a challenging goal. Microbiology professionals often recount stories of distressed point-of-care providers urgently requesting STAT culture results. It is nearly impossible to grow bacteria faster, and with diminishing resources and increased volume, there may not be enough eyes to read plates when they are ready. However, a new technology may be able to help improve the turnaround time, and thus, patient outcomes, when used in conjunction with the highly specialised analytical skills in a clinical laboratory.”
Likewise, Dr Shravan Subramanyam, Managing Director, Roche Diagnostics India, says, “With the majority of clinical decisions being dependent on pathology findings, digital pathology empowers the pathologists in such scenarios and many more. It helps them analyse a patient sample from a remote area without either of the patient travelling or the sample being transported. It opens door to telemedicine, which enables patients to get access to top clinicians without having to travel hundreds of kilometres. It enables pathologist and other specialists to collaborate and analyse complex patient cases. These solutions can bring consistency and accuracy to the pathologist by enabling them to analyse most complex cancers using approved artificial intelligence-based algorithms.”
“Pathology laboratory has shifted in status from being an ancillary unit to its current role as an active partner in healthcare delivery. Digital pathology has added a new dimension to diagnostics with a paradigm shift from conventional to digital microscopy. It has opened new opportunities not only for day-to-day reporting of blood and other smears and biopsies but also for an expert consultation, incorporation of artificial intelligence and teaching purposes. With digital pathology, it is easy for two pathologists, to view the same slide at the same time without sitting together in front of one microscope. They can do this from their own offices wherever they are. This reduces the time taken for the pathologist to provide a diagnosis in a difficult case,” opines, Dr Jayaram Iyengar, Head – Histopathology Services, Neuberg Diagnostics.
Talking about the current scenario in India, Satkam Divya, CEO, Klinic App informs, “Consolidation of technology with diagnostic centres have resulted in online bookings being carried out by the customers to avail any type of blood test. Now, well trained phlebotomists reach their doorstep to collect the samples and transfer it to the labs. Followed by receiving of online reports as well through their email id’s which they can directly be shared with doctors without visiting them at their clinic. This has reduced the waiting turn-around time of a patient to conduct a test and seamless collection of report. On a positive note it has increased the potential of collecting more information to form a clinical database of any patient who came online to book an appointment. With this came the storage of large sets of digitised data that can be used for cross reference in the future. It has increased the chances of a more data-driven profession for the pathologists while allowing patients to receive faster diagnosis with more accuracy. Even the labs’ workflow systems are now managed through software for better efficiency and error-free work. The blood test results have more chances of accuracy with less involvement of human interaction for most of the test. This automatically changes the status quo with wide acceptance by all type of customers from various cities across India. ”
An array of new technologies ushering growth of digital pathlabs
A digital pathology enables cellular, molecular, and genetic-imaging at high efficiency and accuracy to facilitate clinical screening and diagnosis. Dr Iyengar spells out, “Digital microscopy involves converting a glass slide that contains either a tissue section or a smear from blood or other body fluids, into a digital file that can be studied as a virtual file in a manner like what we do when we see the slide under a microscope. Various fields can be examined with zoom-in and zoom-out of areas of interest which can then be annotated and captured as still images if needed. The processes followed for preparing stained slides remains unchanged. The difference is that the stained slide is digitised and the digital file is viewed by the pathologist on their computer monitors instead of the microscope before making the final diagnosis and report.”
Explaining further, Subramanyam adds, “They effectively replicate the way a pathologist would manually score a slide. An objectively quantified analysis result of the entire slide is instantly available after a pathologist selects the entire tumour area they want to analyse. This allows the pathologist to more quickly and effectively diagnose marginal, difficult, or hard to read cases. WSA algorithms allow pathologists to work as they would under a glass microscope while providing fast and accurate results that are validated for clinical use. The new digital solutions are also supported with enterprise software’s that enhance the efficiency of pathology laboratory workflow with connectivity and automation. They
provide a universal platform that seamlessly enables communication between pathologists and technicians via usability, innovation, and digitisation.”
Hence, the use of digital technologies could help make the field of in-vitro diagnostics more robust, producible, and it could push the field from a purely qualitative function to perform a multi-pronged role of focussing on improving quality and quantity as well as reducing cost facts. Additionally, technologies such as AI, machine learning and automation can support pathlabs in multiple ways.
“The latest technologies like web technology, Internet of Things (IoT), Artificial Intelligence, Machine Learning, predictive analysis have shown an exceptional impact on the way the labs and diagnostic centres are conducting their tests. Internet of Things (IoT) has introduced the temperature check on a blood test sample that is conducted through the software while earlier it was done manually. Web technology has proved beneficial for both the patients and the physicians to connect easily. Artificial Intelligence and machine learning have improved the accuracy rate of the reports, ease of navigation are helping the pathologists to work on imaging. In short, the array of vast technology has driven more centralised information stored in one set of database and image archives as well. This will automatically increase the patient’s reliability more on those tech-enabled platforms to opt for their test centres”, says Divya.
Dr Iyengar chips in,“ Apart from automation of existing processes and testing platforms we have moved into the era of precision medicine. This is achieved with technologies like immunohistochemistry, cytogenetics, genomics, proteomics and metabolomics. Microarray and film array technology are being used to rapidly diagnose a wide range of life-threatening bacterial, viral and fungal infections giving the critical time advantage for effective treatment without complications. Mass spectrometry is being used for accurate quantification of medications, hormones, vitamins and steroids. These are only a few examples.”
Digitised workflow – from electronic microscopes to cloud to big data analytics
Turning microscopic slides into digital files has enabled labs to generate big data analytics and more. It opens several avenues for unlocking medical breakthroughs, solving complex healthcare problems, enhance medical education, and foster clinical research.
Speaking about how the digital workflow connects labs with patients, “The digitised workflow has now simplified the accessibility for both the diagnostic centres and at the patients’ end. With the usage of AI and machine learning, a value-chain is created right from the web portal of online booking to collection of the sample, to transferring of the blood sample to sharing of e-reports. It has given a better scope of recording patient data which can further be utilised for future reference. While accepting the booking online for an appointment, clinical/health information is retrieved from the customers. Besides, it has given liberty to the customers to conduct their blood test and also collect it at their preferred location and time. The medium of sample collection and report generation has also been changed with the coming in of the technology. The reports are being shared on the respective email id of the patients provided at the time of booking”, informs Divya.
Moreover, this also allow having opportunity to have digital archives of patients’ samples rather than having to rely on preserving a slide or frozen section that requires physical space for storage, makes immediate peer consults challenging, and may be subject to degradation, inform experts.
Dr Iyengar shares his experience of utilising the digital pathology. “Our initial experience with use of digital microscopy using WSI began seven years ago, when we applied this technology in a limited manner to share virtual slides to over 50 laboratories across India as part of a quality assessment programme. The full-fledged utilisation of digital pathology to study and report on biopsies received every day began in November 2014, which was preceded by a series of validation studies. At that time, there were very few pathology centres across the world and none in India to have achieved this. Our pathologists have adapted to the transition from microscope to monitor quite comfortably. Digital technology has also been applied in our lab for routine reporting of blood smears and urine samples by use of dedicated slide scanners that not only digitise the image but also categorise the subtypes of cells, casts and crystals into different classes based on analytical algorithms. Video image analysis is also employed for the study of semen samples in individuals with infertility. In addition to the above, we utilise digital technology for consultation of difficult cases with experts across the globe, for teaching purposes and to conduct quality control programmes in histopathology. Our quality assessment programme (Neu-QAP) conducted by Neuberg Anand Academy of Laboratory Medicine has 138 laboratories that are enrolled for the digital histopathology QA programme. Majority of these are accredited labs. Lastly, digital technology is used to archive the whole-slide scanned files for defined period of time. Storage on the digital platform has inherent advantages of ease of retrieval and preservation of the integrity of staining characters.”
To suits the requirements of the pathology sector, some technology companies are developing solutions that span the entire digital pathology IT environment from high-performance compute and high-resolution displays to servers, networking, storage, and software to multi-cloud and big data analytics platforms. “As an e-diagnostic company, we are serving our customers end to end, right from online bookings to sample collection to reports through our phlebotomists. One can easily book a test or package by either going to our website or by downloading the app or they can also directly call us at our toll-free helpline number. The customer gets to choose where and when they would like to avail the service. One can also pay online as well while booking or pay at the time of the sample collection either through cash or online. Our trained phlebotomists visit at the preferred time of the customer to collect the sample. The sample is then sent to one of our certified partner labs and later on gets delivered at the preferred location mentioned at the time of booking. For most of the tests the reports are usually available in 12-24 hours depending upon the kind of tests which are also available online”, shares Divya.
AI, deep learning and automation: Making a difference
Many technology companies believe that the true value of digital pathologies is in leveraging the data that is collected from digital images to create actionable insights. In a brief interview with Express Healthcare, one of the major diagnostics company had informed about the significance of the big data generated through digital archives. Using AI and deep learning, this data can be thereby converted into valuable insights for drug discoveries and developing therapeutic solutions, the company’s spoke’s person informed. Besides, AI, deep learning and more bring immense business value to the overall functioning of labs as well . “A combination of expertise in the lab can take this field to the next level. AI brings consistency and reliability to the lab. It ensures that the pathologist can spend quality time on diagnosis”, reckons Subramanyam.
From a practitioner’s point of view, Dr Iyengar believes that deep learning in histopathology digital platforms enable accurate and consistent quantification of positive signals required for interpretation of immunohistochemistry. They also help in grading tumours such as prostate cancer. “Deep learning is increasingly being used in precision and predictive medicine, based on volumes of data that are used to build such algorithms. Using this technology, one will be able not only to diagnose cancer but also forecast the probable behaviour and even suggest appropriate treatment modalities” he says.
“Laboratories are evolving rapidly with the introduction of AI, as it helped in managing big sets of clinical data. It has enabled the medical practitioners to gather information on individual patients, right from their daily habits to complex, microscopic information such as their genetic code. The AI system is proving to be the most useful tool for pathologists, as they can now use machine learning for incorporating clinical, genomic and radiologic data of a patient to predict the accuracy in diagnosing a disease. The real value derived by the laboratories through AI and machine learning has yielded the cross-functional integration of patient information in their decision making process in prediction and prognosis with more accurate results than earlier. The pathologist can now invest less amount of time in most of the technology oriented results. It can also be applied to analyse the information collected and predict outcomes with potential remedies” adds Divya.
Speaking about how digital technologies can enhance the functioning of automated labs, Dr Rajeev Gautam President – HORIBA Medical notifies, “A simple procedure of slide review is a time consuming and an error-prone activity in any diagnostic laboratory. When automated systematically using the latest automated digital pathology track systems, can bring numerous additional benefits to the diagnostic laboratories. These benefits may range from saving the time of the pathologist, enhancing the accuracy of results, making progress in their research projects and training future pathologists on unique and rare findings that laboratory experts find during their routine practice.”
While experts examine the future of in-vitro diagnostics backed by digital images and more, they say that if digital imaging methods are powerful enough to analyse individual cells, pathology could become an entirely different branch of medical sciences. There seems to be an immense opportunity for the field to expand further and unlock complex medical puzzles. But some pathologists continue to worry about their future. Answering to some concerns raised by pathologists on whether digital pathologies could make them redundant, Dr Iyengar replies, “The fear of redundancy that haunts some pathologists is unfound. Most pathologists rely rather heavily on their gut feel while studying a slide and with experience they get good at this. One needs to understand and take advantage of what these new tools can offer in adding objectivity to one’s approach. In my view, these tools will serve to reinforce and not to replace the gut feel”. As Dr Iyengar pointed out, digital technologies could transform the job of pathologists into a more creative and data-driven profession.
Need for standardisation in future
Well, the adoption of digital pathology is still at its nascency and the implementation it will indeed come with some challenges. One of the most important concerns expressed by pathologists and clinical experts is standardisation. Processes such acquisition of images, storage and management, image manipulation and editing, image viewing, transmission and sharing will certainly need standardisation. Lack of standardisation can jeopardise the very purpose of building such advanced technologies. Therefore, experts suggest that in future to integrate digital pathology into a clinical setting, rapid and stable scanning must be achieved. An international standard for digital archiving is also required. This includes re-working laboratory protocols and developing new scanning rules to attempt standardisation of digital imaging procedures.
According to NHS England’s National Pathology Programme and the Research Gate study, the benefits of digital pathologies are mentioned below:
- With digitisation, pathology lab can increase organisation, streamline processes, increase caseloads, and reduce turnaround time, thus obviating many day-to-day logistic oriented delays in traditional lab.
- Pathology digitisation facilitates remote communication and collaboration across locations and specialities.
- Cross functional integration and aggregated views of a patient clinical data help better informed decision making.
- As larger sets of clinical data can be archived and tracked by digitisation, access to a larger volume of expert knowledge can lead to advancement in diagnostics and uncover of new insights.
- Digital pathology enables instant sharing of results with multiple departments and colleagues, inclusion of digital images with pathology report, computerised quantitative analysis for prognosis scores, eliminating risk of break of glass slides in transit and so on.
- Digital pathology enables performing automatic case reviews and tracking of slide assessment for completeness In addition to image analysis efficiency, precision and reproducibility, thus substantially improves quality assurance.
- As a teaching aid, digital slides with inherent robustness and longevity are a great advancement over glass slides which may fade, break or get misplaced. Digital scan of a single tissue specimen can provide slides for several teaching classes and enables students to experience a wider range of cases.
- Besides facilitating image sharing and collaboration for a variety of cases, enabling efficiencies in tumour boards, second opinions and access to sub-speciality expertise, automated digital imaging analysis in clinical setting such as diagnostic HER2 assay, enables reproducible and objective stratification of patients into cohorts of likely responses to drug therapies and eliminate inter- and intra-observer interpretation variability.
- With increased sub-specialisation of pathologists, the ability to engage with experts in a given field is greatly enhanced by digital pathology, which helps with difficult evaluations and streamlines access to the right experts, with ultimate improvement in turnaround time for decision support to he benefit of researcher, healthcare provider and patient.
- Digital pathology will enable pathologists and pathology departments to be more efficient. The ability to view images from any location in the world will allow them to be more flexible and to provide specialist or second opinion quickly, thus responding rapidly and accurately, especially with routine cases, which will give more time for dealing with difficult cases.
- As digital pathology enables collaboration between pathologists as well as within cross-disciplinary teams, pathology labs will be able to offer expertise to regions beyond their current scope where experienced or specialised pathologists are scarce.