Rapid Progress in Systems Biology Predicted to Increase Multiplex Testing by Clinical Pathology Laboratories
Trend from reductionism to holistic biomedicine means clinical laboratories and pathologists should expect increased multiplex testing
Systems biology (SB) is a rapidly-evolving area of research that, by itself, could greatly expand the need for multiplex testing performed by clinical laboratories. But systems biology has yet to catch the full attention of either the media or Wall Street.
That may soon change. Despite the complexity of human metabolic systems, experts in systems biology are making progress in identifying the myriad of metabolic channels that collectively can be used to diagnose disease and identify appropriate therapies. These are auspicious developments for medical laboratory managers and pathologists.
Probably no single individual has done more to advance the field of systems biology than Leroy Hood, M.D., Ph.D. In 2000, he co-founded the Institute for Systems Biology (ISB) in Seattle, Washington and his colleagues engaged scientists across a number of fields to study the metabolic processes of humans and other organisms.
Relative to more widely-publicized concepts like personalized medicine and whole human gene sequencing, systems biology is moving forward with less publicity. Advances in the knowledge of systems biology are being used to develop diagnostic tests, among other purposes. By definition, clinical laboratory test panels built upon a systems biology approach will be multiplex assays because of the myriad of biomarkers which must be evaluated.
“Together with sophisticated analytical methods and computer modeling, multiplexing facilitates a much broader search for meaningful interactions between the components of biological systems,” stated Timothy Galitski, Ph.D., Professor and Head of Science and Technology at EMD Millipore, a division of Merck KGaA, Darmstadt, Germany, and Affiliate Professor at the Institute for Systems Biology. He wrote an article recently published by Genetic Engineering News (GEN). “It enables the analysis of the changing dynamics among these networks between healthy and disease states.
GEN reports that rapid growth in the practice of systems biology among research labs and into medical clinics has led to a new phase of commercial opportunity. Galitski views the field as a growing solution to one of the biggest challenges facing scientists today: navigating biology’s incredible complexity and applying these insights to clinical medicine.
P4 Healthcare Model Shifts Biomedicine from Reductionistic to Holistic
The trend in biomedical science is shifting slowly away from reactive, trial-and-error-based medicine toward P4 medicine. This a concept that has been popularized by Hood and describes an approach to medicine that uses predictive, preventive, personalized, and participatory approaches to maintaining and restoring human wellness.
“The [P4 Medicine Institute] is leveraging systems approaches and pioneering technologies that can… further improve how wellness and illness are managed,” stated Hood, Chairman of P4MI and ISB Co-Founder and President, in a press release announcing the new P4 healthcare model. According to the release, Hood’s discoveries have permanently changed the course of biology and revolutionized the understanding of genetics, life and human health.
“Traditionally, science has taken a reductionist approach,” Galitski wrote in GEN, explaining that this meant dissecting biological systems into their constituent parts and studying them in isolation. The properties of complex biological systems cannot be explained or predicted by studying the individual components. This is because the individual components of biological systems never work alone. Instead, they operate in highly structured and integrated biological networks.
“To gain a true understanding of health and disease will require a more holistic approach, including the integrated analysis at broadly disparate levels, from molecular to organismal, from genetic to environmental,” Galitski wrote.
Multiplex Laboratory Testing Utilizes Developing Technologies
Multiplexing technologies are the technical core of systems biology,” declared Galitski. “At the genetic level, nucleic acid-based multiplexing technologies are becoming standard tools in laboratories as they allow scientists to analyze the structure and expression of many genes in a single experiment quickly and efficiently.”
These technologies are familiar to medical lab managers and pathologists. They include:
- microarray analysis;
- multiplex quantitative polymerase chain reaction (qPCR); and,
- multiplex DNA sequencing.
Galitski pointed out that rapidly-growing fields, such as proteomics, require new tools and technologies that quickly obtain and analyze systems-level datasets that connect numerous biomarkers and pathways to biological states. Traditional detection methods, such as enzyme-linked immunosorbent assays (ELISA) or Western blotting, are impractical in a systems biology setting. This is because they can only detect up to a few analytes at a time. Further, they are semi-quantitative and offer limited throughput.
Other evolving diagnostic technologies that support systems biology approaches and applications include mass spectrometry and microarrays. Both are being used to measure multiple biomarkers simultaneously.
Stories about advances in systems biology and the expected outgrowth of multiplex testing are early evidence for pathologists and clinical laboratory managers that this scientific field is moving steadily toward clinical applications. In turn, this will trigger a need for increase multiplex testing by medical laboratories and pathology groups. Savvy lab leaders will stay alert to opportunities to help clinicians learn about these diagnostic tests and their clinical applications.
—Pamela Scherer McLeod