Digital innovations are shifting the role of laboratory medicine from “a hidden champion that saves lives” toward a higher visibility representing a new paradigm in standard of care.
By Amy Meitus, MD
“I think the biggest innovations of the 21st century will be at the intersection of biology and technology. A new era is beginning.” -Steve Jobs
In this (r)evolution, the lab will most definitely play a key role.1 Clinical laboratories are an essential component of the healthcare and medical sector. More than 13 billion clinical lab tests on various specimen types are performed in the U.S. each year2, providing objective data for accurate diagnosis, prognosis, treatment, and monitoring of patients.
In fact, 70% of today’s medical decisions depend on laboratory test results, showing the important role of clinical laboratories in today’s healthcare system.3
The COVID-19 pandemic has put a spotlight on laboratory medicine, showcasing how vital diagnostic testing is for society and the health care system. It has also shown the widespread scarcity of such diagnostic capacity and capability. The scarcity of high-quality diagnostics has serious and even deadly outcomes for patients, and applies equally to all diseases and conditions, not just COVID-19.4
The world’s population today is about 7.8 billion and is predicted to reach 9.0 billion by 2050; 25% of the U.S. population is expected to be over 65 by 2050 with over half of adult Americans suffering from at least one chronic illness.5
The demand for clinical laboratory services will continue to expand, forcing laboratories to rise to this challenge.6 The escalating cost of healthcare, the ever-increasing workload, the critical shortage of lab professionals, and need for improved precision call for continuous optimization of laboratory processes.
Spurring Innovation Through ‘Creative Destruction’
“Creative destruction” was coined by Austrian economist Joseph Schumpeter in 1942. It describes the overthrowing of an existing (and working) system with a new one having the potential to replace it.7
The COVID-19 pandemic has robustly demonstrated that “creative destruction” leads to accelerated innovation.
The healthcare industry—which is usually the last to adopt digital interventions—has responded to the pandemic by rapidly adopting productivity-enhancing technologies.8
Technologies for remote working such as tele-health services, were the most frequently adopted either alone or in conjunction with other technologies.
Modern Laboratory Medicine and Digital Innovations
Recent technological advances have revolutionized modern laboratory medicine and added significant value and visibility to its role in healthcare and clinical decision-making.
There are multiple reasons to encourage disruptive digital innovation in the clinical laboratory, including the escalating cost of health care, the need for better accessibility of diagnostic care, and the increased demand on the laboratory in the era of precision diagnostics.9
Pathology and laboratory medicine are fertile soils for disruptive innovations because they are heavily reliant on technology.
Digitalization and the Rapid Evolution of Diagnostics
Although being one of the most performed laboratory tests, blood tests may be the most sophisticated and revealing diagnostic available, not just about a patient’s current state of health, but also about what their medical future might hold.
Nonetheless, common blood tests like the peripheral blood smear review, are still predominantly conducted manually by an expert looking at a sample under a microscope, classifying and counting cells by type, hunting for abnormalities that could mean cancer, infections, inflammation, or other diseases.
Back in 2010, it was reported that 71% of the researchers were still counting cells through a microscope manually by using devices like a hemocytometer, a chamber with a microscopic grid on its bottom.10
The study concluded that while hemocytometry is inexpensive, it is laborious and subject to user bias and misuse, which results in inaccurate counts.
In the recent decade, clinical chemistry and hematology laboratories have adopted largely automated analyzers that have broadly improved laboratory testing efficiency, costs, and laboratory-driven errors.11
Digital image analyzers of blood smears are indeed constantly improving and expanding. Yet, they are generally used as a preliminary screening method given their limited fields of view of the Peripheral Blood Smear (PBS).12 Consequently, additional manual microscopic examination is required for the identified abnormal samples.
This method is labor intensive, time consuming, requires continuous staff training, and is subject to relatively large inter-observer variability.13
Additionally, the lack of uniformity among experts in the field, originating from a subjective manual review, can lead to inconsistencies in disease diagnosis and classification, and thereby affect treatment and clinical outcomes. A digital transformation can sustain the desired standardization and increase sensitivity and efficiency in routine workflow.15
Digital hematopathology is disruptive because it paves the way for computational photography and artificial intelligence to transform the diagnostic assessment from being qualitative (relying on subjective assessment by a hematologist or hematopathologist) to quantitative assessment through image analysis.16
Digital Innovation and Workflow Efficiency
Scopio Labs has developed a novel AI-based decision-support system that utilizes a full-field approach for blood cell identification, quantification and pre-classification in both normal and abnormal peripheral blood samples.
The X100 and X100HT platforms with the Full-Field Peripheral Blood Smear Application provides a full-field view of all regions of interest, including the monolayer and the feathered edge, at 100X magnification, the highest resolution available for hematological analysis.
It enables laboratory professionals to view all clinically relevant areas of the blood smear via a modern browser-based application over the hospital’s secure network, accompanied by pre-classification of white blood cells (WBC) and platelets pre-estimation.14
It should be highlighted that the option of full-field specimen viewing during PBS analysis is an unmet need. The full-field capability enables experts to gain general slide context, along with zooming in on the smallest details of a single cell, which is critical for confident laboratory decision-making.14
Scopio’s digital imaging and analysis platform utilizes computational photography to generate a high resolution, full-field image of blood samples, coupled with an AI-powered decision support system that may speed interpretation and reporting of the results.
Such novel platforms will not replace morphologists, but act as a labor-assistance
device to alleviate busy workloads and enhance efficiency. The reduction in slide review time afforded by such AI machine-learning tools and the digital imaging of tens of thousands of cells, eliminates the need for additional manual microscopic examination and would allow hematopathologists to devote more time to abnormal slide examination17 and other valuable tasks.
The clinical study results and accumulated laboratory experience have demonstrated that benefits provided by the Full-Field Peripheral Blood Smear platform:14,15 accelerated PBS analysis, substantially reduced workload, increased workflow efficiency (by 60%), and successfully met the defined levels of repeatability and reproducibility. Two imaging platforms with the Full Field -Peripheral Blood Smear Application have been regulatory-cleared and CE-marked for labs that require high throughput (up to 40 slides/hour) with continuous operation and for labs that need lower throughput (up to 15 slides/hour).
Earlier in 2022, Scopio Labs strategically partnered with Beckman Coulter Diagnostics to accelerate the adoption of its next-generation peripheral blood smear platform globally and augment the digital transformation of hematology laboratories.
Driving Digital Innovations Forward
Laboratory medicine continues to be driven forward by advancements in innovative technologies that represent a new paradigm in diagnostics and hold a great promise of redefining the standard of care.
Such disruptive innovations can transform the future of diagnostics and support laboratory medicine to provide earlier detection and accurate diagnoses of cancers, infections, and other diseases, to expedite access to better care and improve the patient experience.
ABOUT THE AUTHOR
Amit (Amy) Meitus, MD, is chief product officer at Scopio Labs. She is a highly experienced product and strategy executive, with more than 10 years of experience taking large-scale tech projects from ideation to delivery. Prior to her tenure as chief product officer at Scopio Labs, Meitus co-founded and served as COO of Xiom Labs, a biotech startup. She is also the co-founder of SpearHealth and 8200BIO, promoting and accelerating new ventures in the Israeli HealthTech ecosystem. Meitus also volunteers as an emergency medicine physician.
References
- Digital Transformation of the Laboratory: A Practical Guide to the Connected Lab. June 2021 Editors: Klemen Zupancic, Tea Pavlek, Jana Erjavec
- Federal Register Volume 79, Number 25 (Thursday, February 6, 2014)
- Strengthening Clinical Laboratories. The U.S. CDC (Centers for Disease Control and Prevention). https://www.cdc.gov/csels/dls/strengthening-clinical-labs.html
- Fleming KA et al. The Lancet Commission on Diagnostics. Lancet 2021; 398: 1997–2050
- The 2020 World Population Data Sheet. https://interactives.prb.org/2020-wpds/
- Grand View Research; Industry Analysis, Clinical Laboratory Service Market Size Report, 2021-2028
- Michael Neumaier, Diagnostics 4.0. Clin Chem Lab Med 2019; 57(3): 343–348
- Golinelli D. et al. Adoption of Digital Technologies in Health Care During the COVID-19 Pandemic. J Med Internet Res 2020;22(11)
- Khatab Z. et al. Disruptive innovations in the clinical laboratory. Critical Reviews in Clinical Laboratory Sciences 2021, VOL. 58, NO. 8, 546–562
- Ongena K. et al. Journal of Visualized Experiments (45) 2010, pg. 1-5
- Wilson S. et al. Biotechnology & Biotechnological Equipment 2022, VOL. 36, NO. S1, S9–S21
- Kratz A. et al. Digital morphology analyzers in hematology: ICSH review and recommendations. Int J Lab Hematol. 2019;41:437-447
- Eun-Jung Cho et al. Clinical Biochemistry, Vol 56, 2018, pages 70-74.
- Katz B. et al. Int Journal of Lab Hematol. 2021;43:1408–1416.
- Salib C. et al. American Society of Hematology, Blood Journal, Vol 138, Supp 1, Nov 2021
- Hart SN. Will digital pathology be as disruptive as genomics? J Pathol Inform. 2018;9:27.
- Shang Yuin Chai et al. British Journal of Haematology 2022;198:807–811. 2022-10988
