Recent breakthroughs in spatial biology technology have transformed biomedical research. This cutting-edge technology equips scientists to dive into the molecular details of human tissues and organs like never before. Seemingly overnight, researchers gained the power to visualize nearly every single gene (we have about 20,000) in every single cell with spatial resolution, a monumental leap from previous methods, which were limited to a few genes in a few cell types.
This revolution is akin to the transformative shift from the Hubble to the James Webb telescope in space science. Recognized as the 2020 “Method of the Year” by Nature Methods, spatial biology technology ushers in a groundbreaking era. It promises to deliver unprecedented insights into complex diseases, from cancer and diabetes to Alzheimer’s and other forms of dementia.
A shift to commercialization
Embarking on this exciting journey of discovery requires significant financial backing. Notable funding from the National Institutes of Health (NIH) has fueled pioneering scientists, turning groundbreaking ideas into commercially available platforms. This funding is crucial for ensuring equitable access to resources by dismantling technological barriers.
The NIH advocates for the transition from discovery to commercialization where innovations reach companies and eventually impact human health. This shift allows for scalability and rigorous standardization, ensuring laboratories worldwide generate comparable high-quality data. As these experiments can influence medical decisions, it is critical that scientists in London or Sydney obtain the same result from a tissue biopsy as scientists in New York City. Biotechnology companies play a key role in making innovative discoveries, commercializing them, and placing them in laboratories globally, thereby advancing scientific frontiers.
A rise in litigiousness
Unfortunately, the promise of spatial biology technologies has become clouded by a troubling reality: the clash of profit, power, and attempted monopolization. What should be headlines of groundbreaking advancements in fatal diseases through the use of spatial biology are now headlines dominated by legal disputes waged by powerful companies. Instead of international collaborations driving biomedical progress, conversations have shifted to technology restrictions and legal battles.
The focus is no longer on impactful discoveries, but on which companies are at risk of succumbing to legal pressures from deep-pocketed powerhouses. It is a concerning twist in a narrative that should be about advancing science for the greater good.
In the scientific arena, litigation has turned a once exciting field into an environment filled with complex and challenging situations. These conflicts are stifling small, innovative companies from advancing new technologies and ideas due to financial constraints, irrespective of eventual legal outcomes. This poses a threat to the progress of even the most promising scientific technologies and the potential discoveries they could enable.
Unfortunately, legal battles have driven the closure of promising companies that were unable to navigate the negative repercussions of these disputes. Additionally, the litigious atmosphere is discouraging emerging companies with groundbreaking solutions in spatial biology from patenting and publicizing their innovations, fearing potential lawsuits. The short-term gains for a few companies come at the cost of losing valuable contributions to long-term advances in biology. The consequence is clear: the legal battles are casting a shadow over scientific innovation and biomedical progress.
This legal behavior undermines fundamental principles of innovation, transparency, access, and diversity. Fear of litigation stifles innovation, leading to a lack of transparent methods. The restricted access to instrumentation, with an increasing number of countries facing bans on use of some spatial biology technologies.
At present, scientists have invested in good faith in spatial biology technology that can no longer be utilized, leaving research projects supported by charitable and governmental funding in limbo. A similar situation is now even threatening the United States. Perhaps most alarming, diversity in technology is waning. Healthy market rivalries are vital for driving innovation and ensuring quality as well as competitive costs for consumers—yet, in this climate, these principles are under threat.
For example, the lack of competition and the ongoing litigation pose a threat to patient care, particularly in laboratory settings where spatial biology analysis is used to select therapies. The Clinical Laboratory Improvement Amendments (CLIA) of 1988 set federal standards for facilities testing human specimens. Only one technology from a smaller company meets the necessary criteria to be implemented in CLIA laboratories, offering patients access to promising precision oncology therapies. However, this technology is facing legal challenges that could potentially block its use.
A call for antitrust action
We are urging spatial biology companies to engage in fair competition, and we are advocating for antitrust measures. The ongoing litigious environment has negatively impacted competitive progress, and we are concerned about the potential emergence of monopolistic behavior that could hinder innovative patient care. It is a troubling state of affairs that demands attention and reform for the sake of biomedical progress.
We stand at a critical crossroads, and scientists are sounding the alarm. The legal battles are casting a dark shadow over the once-thriving collaborative and innovative spirit propelling spatial biology’s rapid progress. These legal challenges are not just courtroom dramas; they are stifling the very momentum of scientific discovery, dimming the beacon of scientific advancement, and delaying clinical impact. It is a moment of concern that demands our attention and a collective effort to safeguard the spirit of exploration and innovation in spatial biology.
Authors and affiliations: Miranda E. Orr, PhD, associate professor, gerontology and geriatric medicine, Wake Forest University School of Medicine. Arutha Kulasinghe, PhD, group leader, Clinical-o-Mx Lab, Faculty of Medicine, University of Queensland. Grant R. Kolar, MD, PhD, professor of pharmacology and physiology, Saint Louis University. Holger Heyn, PhD, team leader, Single Cell Genomics Group, Spanish National Center for Genomic Analysis. Jasmine Plummer, PhD, associate member, St. Jude Faculty, and director, Center for Spatial OMICs. Lasse Sommer Kristensen, PhD, associate professor, Department of Biomedicine, Aarhus University. Jorgen Kjems, PhD, professor, Department of Molecular Biology and Genetics, Aarhus University. Gordon Mills, MD, PhD, professor of cell, developmental and cancer biology and director of precision oncology, Knight Cancer Institute, Oregon Health and Science University. Juan J. Garcia-Vallejo, PhD, associate professor, Molecular Cell Biology and Immunology, Amsterdam University Medical Centers, I.J. Nijman, PhD, manager, Utrecht Sequencing Facility, Bioinformatic Facility, and High Performance Compute Facility. University Medical Center Utrecht (Center for Molecular Medicine) and the Netherlands X-omics Institute. Nicholas P. West, PhD, associate professor, Central Facility for Genomics and School of Pharmacy and Medical Science, Griffith University. Amanda Cox, PhD, senior lecturer, Central Facility for Genomics and School of Pharmacy and Medical Science, Griffith University.
Note: This point-of-view article is based on the opinions of the authors and not their employers.
Editor’s note: See the following links for GEN’s recent coverage of the patent dispute impacting the spatial biology field: story on NanoString filing for Chapter 11 bankruptcy, interview with Serge Saxonov, PhD, CEO of 10x Genomics, interview with Joe Beechem, PhD, CSO of NanoString.