While we might like to think we know ourselves and what we are made of, looking into the components that make up our bodies tells a different story. While estimates vary, it is clear that microorganisms make up a significant portion of our bodies, likely outnumbering human cells [1]. While “microbiome” has become a buzzword used in settings ranging from academic research to the probiotic section of the grocery store, this wasn’t always the case. When Antoine van Leeuwenhoek first observed microbiota under his handcrafted microscopes in the 17th century, he discovered what he called “little living animalcule”[2]. Little did he know, he would set the stage for the great advances in our understanding of the microscopic world of bacteria, viruses, archaea, and fungi now known as the microbiome.
In recent years, the microbiome has become intimately implicated in human health, associated with many of the chronic diseases that pose the greatest burden to society. For this reason, it has become a hub of innovation, with several universities creating centers for microbiome innovation and the White House creating the National Microbiome Initiative in 2016 to advance research and translation. There is also a growing list of companies that seek to harness the role of the microbiome as it relates to human health, such as Pendulum Therapeutics in the realms of diabetes and weight loss and veMico in the field of skincare. AI, machine learning, and deep learning are being applied as tools to further fuel innovation, as they can help to derive insights from the trillions of microbial cells in the body [3]. The ability to harness the vast amounts of data available has also led to exciting possibilities for making comparisons between individuals that can be used to tailor precision medicine approaches.
Just as advances in genetic sequencing technology fueled the rise of direct-to-consumer (DTC) DNA testing companies like 23andMe, a multitude of companies offering DTC microbiome analysis have sprung up in recent years. As of January 2024, the University of Maryland, Baltimore identified 31 microbiome-based DTC companies in existence, with most operating according to a model where customers send in a biospecimen which is then analyzed to generate a report with personalized recommendations and health insights [4]. Similar to the case of DTC genetic testing, these DTC microbiome-based companies offer consumers the promise of unlocking important knowledge about their health that would otherwise be hidden and inaccessible.
While the microbiome offers an exciting arena for innovation and insight into human health, the rise of the DTC landscape has brought up many of the same ethical and regulatory issues associated with DTC genetic testing. One important aspect is ensuring that the tests are analytically and clinically valid, which refers to the fact that the tests measure what they intend to measure and that the results are accurately indicative of healthy versus disease states [4]. Calls for regulation of these DTC companies cite the fact that there is not yet consensus among researchers about what constitutes a healthy versus an unhealthy microbiome, leading DTC companies to market their results as “recommendations” rather than “diagnostic”, a distinction that the average consumer may not understand [4]. In addition to these quality concerns, there have also been flags raised around consumer data privacy, possible psychological impacts of results delivered without the counsel of a healthcare provider, and the difficulty of delivering enough information to consumers to obtain true informed consent [5]. While all of the previous concerns apply to both DTC genetic and microbiome testing, there are also additional ethical issues uniquely related to the microbiome, as it opens up a new philosophical conversation on the relative importance of microorganisms in our conception of self [6]. Given the popularity of DTC genetic testing, it is likely that microbiome-based DTC testing will continue to expand and gain attention over the coming years. Because regulation continues to lag behind innovation in this space, it will be up to consumers to do the work of informing themselves about the possible risks and benefits before choosing whether to have their microbiomes analyzed before this type of analysis becomes integrated into clinical care.
Reviewed By: Connor Barritt
Designed By: Allison Chin
References
[1] Abbott, A. (2016). Scientists bust myth that our bodies have more bacteria than human cells. Nature. https://doi.org/10.1038/nature.2016.19136
[2] Pariente, N. (2019). A field is born. Nature Portfolio. https://www.nature.com/articles/d42859-019-00006-2
[3] Abavisani, M., Khoshrou, A., Foroushan, S. K., Ebadpour, N., & Sahebkar, A. (2024). Deciphering the gut microbiome: The revolution of artificial intelligence in microbiota analysis and intervention. Current Research in Biotechnology, 7. https://doi.org/10.1016/j.crbiot.2024.100211
[4] Hoffmann, D.E., Von Rosenvinge, E. C., Roghmann, M. C., Palumbo, F. B., Mcdonald, D., & Ravel, J. (2024). The DTC microbiome testing industry needs more regulation. Science, 383(6688), 1176-1179. https://doi.org/10.1126/science.adk4271
[5] Panacer K. S. (2023). Ethical Issues Associated With Direct-to-Consumer Genetic Testing. Cureus, 15(6), e39918. https://doi.org/10.7759/cureus.39918
[6] Ma, Y., Chen, H., Lan, C., & Ren, J. (2018). Help, hope and hype: ethical considerations of human microbiome research and applications. Protein & cell, 9(5), 404–415. https://doi.org/10.1007/s13238-018-0537-4
Σχόλια