Making a difference

To survive in this rapidly changing environment, clinical laboratories need a high level of flexibility to quickly adapt to constant shifts and unpredictable new terrains.

The SARS-CoV-2 pandemic’s extreme disruption was by no means limited to the medical device industry; virtually every industry floundered as they struggled to cope with travel restrictions, social distancing guidelines, skeleton crews of employees on site, and anxiety about how long the pandemic would rage on.

The medical device industry, however, was uniquely impacted for a number of reasons. Procedures considered elective were cancelled or postponed to free up critical hospital beds. MedTech makers who provided technologies used in elective procedures – orthopedic manufacturers, for example – watched their revenue plummet as hospitals purchased far less of their products.

Though some sectors were handcuffed, the pandemic has also spurred the mission-critical diagnostics industry into action. A race promptly began to develop novel and rapid diagnostics kits to detect coronavirus. The US Food and Drug Administration (FDA), recognizing the crisis, approved integral pharmaceuticals, MedTech, and diagnostic tests under its far less stringent emergency use authorization (EUA).

According to Grand View Research, the infectious disease segment dominated the in-vitro diagnostics (IVD) global market and accounted for the lion’s share of revenue – 41.8 percent – in 2020. This was attributable to increasing COVID-19, HIV, AIDS, tuberculosis, and pneumonia incidence.

The staggering demand for COVID-19 diagnostic tests sent shockwaves through the IVD industry. Once a test had been developed and evaluated, even prior to EUA, test makers had to immediately ramp up production to astronomical levels. As a result, they likely leaned heavily on their manufacturing partners. Manufacturers of RT-PCR tests, antigen tests, next-generation sequencing (NGS) tests, and antibody tests felt the squeeze as demand ballooned.

A cadre of diagnostic test manufacturers – LabCorp, Quest, Thermo Fisher, Roche, Abbott Laboratories, Becton Dickinson, and a slew of others – have secured FDA EUA for their own COVID-19 PCR tests. As a result, IVD component manufacturers serving this sector have witnessed projects surge to assist their diagnostic test manufacturing partners.

Major assays used for COVID-19 detection employ the RT-PCR technique. Although the conventional test takes 5 to 6 hours for result output, point-of-care (POC) assays have reduced the duration significantly.

Antigen tests commonly used to diagnose respiratory pathogens like flu and respiratory syntactical virus also gained relevance for COVID-19. They detect the presence of a viral antigen in a sample, implying current viral infection. Administered via nasopharyngeal or nasal swab, specimens are placed directly into the assay’s extraction buffer or reagent. They are relatively inexpensive, and most can be used at the point of care.

The pace of innovation in medical science is accelerating but are the labs able to keep up with the rapid transformation? Perhaps no! The need of the hour is digitally empowering the labs to use state-of-the-art research and make them globally connected powerhouses, capable of breakthrough innovation at scale.

According to an Accenture study, life sciences companies, in particular, are applying digital to R&D or quality-control labs. Around 60 percent companies are deploying digital, as 37 percent are piloting, 13 percent are scaling up, and 10 percent already have digital technologies in widespread use.

The modern lab will dramatically transform how tests are conducted and biopharma products are created. With a broad focus on validation, knowledge management, new assay development, contract research, new technology evaluation, and R&D services in the field of genomics and proteomics, these labs will bring latest innovations, advanced concepts, and technologies for the benefit of clinicians and patients. In R&D, it will make previously inaccessible, miniaturized, and complex assays routine and fully automated. Further, quality-control wise, the use of extended reality (XR) will become commonplace to ensure tech transfer, train, and provide technical support on new methods.

As technology continues to revolutionize life and work, there is an escalating need to provide a modern, quality-driven digital approach to laboratory operations that offer consumers unprecedented convenience, impactful innovations, and reliability.

The future is at home diagnostics which would allow phlebotomists to conduct testing and deliver results instantly. The purpose is to enable a new generation of medicines where the operations can extend into peoples’ homes and the diagnostic continuum can empower a truly connected, accessible, and omnipresent vision of health.

One shall foresee state-of-the-art, harmonized system for clinical diagnostics that facilitates testing ability for immunoassay, serology, clinical chemistry, POC, clinical microbiology, clinical microscopy, hematology, cytopathology, transfusion, and molecular diagnostics. A series of advancements are poised to change the industry’s testing paradigm through speed, quality, efficiency, and scalability to help guide care for patients. Healthcare system is increasingly recognizing the added value the laboratories can play in becoming more of a clinical decision engine, helping patients perform tests at home, and physicians interpret results, and diagnose and monitor patients accurately and faster.

Diagnostic tests for COVID-19 will likely capture significant share of the IVD market for months to come. But the pandemic will eventually subside – soon, everyone hopes – and other applications will take center stage again. Development of automated IVD systems for labs and hospitals to provide efficient, accurate, and error-free diagnosis is expected to fuel market growth, reiterates Grand View Research. The prevalence of diseases like cancer, autoimmune diseases, and inflammatory conditions is also increasing worldwide and is expected to drive the demand for IVD testing.

Even once COVID-19 comes under control, the IVD market is excpected to grow exponentially in the fields of genetics, disease treatment, and detection. This is Moore’s Law on steroids, with new mNRA technology leapfrogging itself in speed seemingly monthly. The stalwarts of the business (Bio-Rad, Thermo-Fisher, Becton Dickinson, and the like) will certainly prosper, but there are some upstarts that will have the old guard looking over their shoulders. The consumables aspects of these devices will be a massive market for injection molders and assemblers.

To better prepare for unprecedented infectious diseases, public, private, and global government entities are anticipated to increase funding for improved patient care. This will likely encourage development of new disease test platforms, discrete and multiplexed. Investments of this nature may also accelerate development of new diagnostic technologies, such as NGS and CRISPR.

NGS methods – combined with increasing adoption in clinical diagnosis, genomic research, and personalized treatment of a number of diseases – are fueling demand for precise and rapid sequencing interpretation tools and algorithms to expedite data analysis. High genetic data output and a concurrent drop in sequencing prices expect to augment the scope of sequencing projects.

The NGS market size is forecasted to reach about USD 6.9 billion in 2023, according to life sciences strategy consulting firm DeciBio. SARS-CoV-2 NGS testing will represent a small fraction of the industry – about USD 500 million this year – and taper off in the coming years. But other applications for NGS will likely increase as the technology becomes more widely adopted.

CRISPR is a technology used to edit genes. Its essence is simple – It is a way to find a specific bit of DNA inside of a cell. After that, the next step in CRISPR gene editing usually alters that piece of DNA.

CRISPR has been adapted for numerous applications. Last February, Cepheid and Sherlock Biosciences began a research collaboration to develop cutting-edge molecular diagnostics tests leveraging Sherlock, a CRISPR-based technology that can purportedly identify virtually any target. The new tests will run on Cepheid’s GeneXpert systems. At the time of announcement, the collaboration intended to focus on molecular diagnostic tests for infectious diseases and oncology, beginning with a proof-of-concept project focused on coronavirus detection.

Moreover, expedited market introduction and the ability to accommodate faster and higher testing volumes will continue, if not increase. Lastly, POC testing has become more popular amid the pandemic. Continued growth is expected for this method, along with patient self-testing formats that use minimally invasive sampling methods and affordable consumables.

Rising demand for POC IVD devices has been a major driver for growth. Recently launched POD IVD instruments and devices are convenient to use and efficient, increasing adoption. The trend of self-monitoring conditions in a proactive healthcare approach is also on the rise, necessitating smaller, more functional, and user-friendly platforms.

Over the next several years, traditional tests based on clinical chemistry, immunoassays, hematology, and conventional microbiology will account for the largest share of global procedural volume, or more than 83.3 percent of non-glucose tests in 2025. These older technologies will continue to build up patient volume, based on low cost, broad applications, improving methods, and increasing availability in POC laboratories.

The IVD space is moving more into miniaturized implantable devices – CGM sensors, bio-integrated sensors, and microelectromechanical systems that enable sophisticated diagnostic techniques as well as monitoring and managing glucose levels. Terminal sterilization of these devices is a vital step in manufacturing to ensure patient safety. It is imperative to determine optimal sterilization modality early in product development. E-beam has emerged as the preferred terminal sterilization method for these devices because it offers flexibility to optimize post-sterilized performance functionality and performance with continuous temperature control, split-dose processing, and intelligent shielding.

The world of diagnostics, like so many other industries, is entering what leaders in the World Economic Forum refer to as fourth industrial revolution. Digitization, robotization, and automation have given rise to highly flexible smart factories as well as laboratories that can handle both routine/high-volume analyses and highly customized analyses at competitive prices. This is coupled with an ongoing integration of the entire value chain – from subcontractor to customer.

As this wave of integration expands to encompass different fields of science, such as biotechnology, genetics, and nanotechnology, it is leading to an accelerated rate of change that generates new and very disruptive technologies. To survive in this rapidly changing environment, clinical laboratories need a high level of flexibility to quickly adapt to constant shifts and unpredictable new terrains.

Disruptive advances in science like genomics and personalized medicine are shaping the future of clinical diagnostics.

Here are four major trends that are transforming clinical diagnostics.

Rapid advances in genomics powered by automation technologies. The accuracy of genome sequencing has improved dramatically over the last years. Additionally, sequencing platforms have become more affordable, as have platforms for library preparation, both of which are making the technology more widely available. Furthermore, advances in data analytics have improved the understanding of genomics by revealing hidden patterns, unknown correlations, and other insights, particularly when examining large-scale data sets. At the core of this development are automation technologies that enable much higher throughputs, flexibility, and low-cost solutions. Furthermore, decreased costs of DNA genotyping and sequencing have made DNA testing available to consumers, resulting in an unexpectedly strong growth rate of the number of consumers who want genetic testing. A vast majority of consumers consent to making their samples available for research; the sheer volume of biological data that is generated is growing exponentially.

Personalized medicines and patient-centric approaches. A major driver in society is changing consumer expectations. The ageing population worldwide, especially in the Western world, expects not only to live longer but also to enjoy healthier lives. With this expectation comes a demand for more individualized solutions. The last decades have seen a growing interest in personalized diets and training programs as well as tailor-made cosmetic procedures and products. Inevitably, the natural development is personalized medicine, which has become all the more feasible with genomics and by applying automation to healthcare. While medicine so far has centered around standardized procedures, based on a statistically average person who does not really exist, automation and robotization of clinical diagnostics have implied that medical treatment can now be tailor-made according to a person’s own genetic makeup. These advances mean that healthcare is moving fast toward truly patient-centered approaches.

Groundbreaking research increases need for flexibility. New market opportunities are on the rise due to groundbreaking research in areas, such as cancer immunotherapy, stem cell technology, gene editing, and regenerative medicine. These paradigm-changing breakthroughs open up new markets and business opportunities for clinical laboratories, given that they can simultaneously meet the corresponding safety requirements and quality standards. This means that IVD companies and clinical laboratories need advanced equipment, with a high degree of flexibility and automation, to be able to continuously adjust their workflow for brand new applications.

Greater complexity in clinical diagnostics. More samples, more data and more experimental variations – as well as the advancement of genetics and the demand for new innovative therapies – have implied an increasing complexity of clinical diagnostics. This will necessitate sophisticated systems with a high level of automation and robotics that can be adapted to different processes and workflows. Emerging technologies, such as cloud computing and machine learning, will be a great aid for tomorrow’s laboratories, making it easier to analyze and share data. Cloud computing enables research groups to collaborate and access huge volumes of data in real time. Machine learning uses algorithms to learn from data and to get more insights and make predictions.

These trends not only bring new exciting possibilities for clinical diagnostics, but also present new challenges – an array of heterogeneous technologies, concerns regarding safety issues and the integrity of individuals, and an ever-changing environment that needs to be dealt with. With the fourth industrial revolution, constant change is becoming the new normal. There is no gold standard technology or solution to these challenges. Instead, those who can adapt to a constantly changing environment will be the winners of the game.

To tap into new potential business opportunities, clinical laboratories will need to adjust and change their processes on a continual basis. This necessitates built-in flexibility in clinical diagnostics applications to, for example, switch between customized and generic services or to switch to new market segments – immunoassay, mass spectrometry, molecular testing, and so forth – in other words, to be able to move rapidly wherever the market is going.

The development of innovation in healthcare depends on a number of key factors including the available infrastructure, the knowledge base, the available strength of evidence; and the flexibility and creativity of systems where innovations are composed, tested, and eventually adopted and incorporated into routine practice. Especially, in fields, such as medical research where creativity is a key feature, the role of the knowledge base is further enhanced as a critical precondition for the development of highly adopted innovations.

However, accumulating a critical mass of innovations, such that the result is to widen a transformation of the healthcare system, is a rather rare event and is often comparable to the systemic transformations of economic systems. One of the reasons that such innovation-driven, systemic transformations are rare is because they also necessitate social alignment for their success.

The pandemic constitutes perhaps the defining moment at which healthcare information is not simply available at high volumes and speed but is also expected to be interpretable as an integral part of any innovation.

One reason systems transform in long waves is because prior frameworks of operation establish firmly committed procedures that are not easily disrupted. Thus, it takes the exhaustion of existing systems before innovative approaches are considered and even adopted. This might explain why innovations that have been available for years or decades, but not widely implemented, have suddenly become the norm during this pandemic.

The COVID-19 pandemic, as such, has exposed the deficiencies within different clinical care systems, and highlighted the need for innovative approaches. The urgency of the response has also mitigated or completely removed any potential financial and social barriers.

However, it is important to note that although the pandemic has heightened interest and accelerated development in medical technologies, as well as provided the ground for the rise in technological innovation within medical research, it does not as yet constitute a systemic transformation. To do so, introduced innovations need to become widely adopted and integrated across a range of settings, from affluent to resource restricted.

Therefore, there remains a very real risk that the innovations introduced in the last few years – and the knowledge base that they embody – will not be effectively institutionalized once the crisis subsides, and there will be a return to the pre-COVID-19 status quo. Perhaps the most transformative legacy of the pandemic in healthcare would be the acceleration of the innovation pipeline, allowing new approaches to emerge and be tested more rapidly than ever before.

The next critical step would be to focus on applying these innovative technologies where they add value, while widening their reach and eventual adoption globally.