Precision-Medicine Development
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The term precision medicine refers to a medical model in which information about a patient's biological makeup, environment, and lifestyle sees use to enhance medical treatment and disease prevention. Although the field is still in its early stages, precision medicine has the potential to improve patient care substantially while also boosting demand for point-of-care sensing. For physicians and patients, precision medicine promises improved medical outcomes. For pharmaceutical companies, precision medicine has been an important growth driver. For sensing and bioinformatics companies, precision medicine could greatly increase demand for their products and open up many new markets.
Precision medicine takes individual variability into account in both prevention strategies and disease treatments. Indeed, one of precision medicine's early uses was to prescribe drugs for groups of people with certain biological commonalities. For example, in 2005, the US Food and Drug Administration approved a drug (trade name BiDil) that is specifically for African Americans who suffer from congestive heart failure. Since then, advances in synergistic technologies have enabled precision medicine to revolutionize the treatment of some cancers and rare genetic diseases. The following bullets discuss several key technology areas that are helping to drive the advance of precision medicine.
- DNA/RNA sequencing. Having found use in research for many years, DNA sequencing is increasingly active in precision medicine. Genome sequencing can aid medics in developing treatment plans that are likely to be most effective to the individual. Lower costs and smaller benchtop machines have made the use of DNA sequencing in clinical applications viable. Indeed, dramatic improvements in the size, cost, and speed of new sequencing devices have enabled whole-human-genome sequencing for a thousand dollars or less to become routine. Because sequencing is more accessible, science's understanding of genetics is advancing rapidly.
- Bioinformatics. Bioinformatics is key to deciphering and understanding the vast quantities of data that DNA and RNA sequencing create. The development of software tools is an essential part of making sense of these data, fast-tracking the progress of research, and enabling clinicians to put an end to trial-and-error drug prescriptions. Bioinformatics is increasingly embracing big‑data tools to manage large and voluminous data sets. Artificial-intelligence technologies—which are finding integrated use with bioinformatics technologies—may reshape precision medicine by accelerating traditional data-heavy processes, automatically extracting insights from data for researchers, and enabling high-precision medicine that targets patients' individual conditions.
- Protein engineering. Engineered proteins play very significant roles in the development of novel therapeutic approaches. The two main methods of protein engineering are rational design—in which new molecules see design on the basis of predictions about how the structure will determine the molecule's behavior—and directed evolution. Typically, both methods see use together in protein engineering, but directed evolution has produced exciting results by replicating the process of natural selection to evolve proteins for specific purposes. Protein engineering is an important part of the development of synthetic biology and its use in designing personalized treatments.
- Genetic engineering. Understanding genetic data is enabling scientists to identify and manipulate genes of interest. Genetic engineering has existed for decades, beginning with the use of recombinant DNA. In recent years, the development of CRISPR‑Cas9 (clustered regularly interspaced short palindromic repeats-CRISPR associated protein 9) and other CRISPR‑Cas systems has offered an accurate and fast method of adding or removing target genes from the genome.
- Synthetic biology. Advances in genetic engineering and protein engineering are aiding in the creation of synthetic biological systems. Much of synthetic biology's application in precision medicine consists of designing and developing devices that can expand scientists' understanding of disease mechanisms. Cutting-edge research in synthetic biology is also focusing on creating novel diagnostic tools. In a February 2022 interview with Raju Narisetti, McKinsey & Company's director of global publishing, futurist and business advisor Amy Webb highlights that synthetic biology is seeing a massive amount of capital (partly catalyzed by the covid‑19 pandemic) that could lead to significant industry and ecosystem development in the next two to three years.
The clinical availability of precision medicine will likely bring major shifts in the medical-care, pharmaceuticals, insurance, fitness, and other health-related industries. People's increasing awareness of their own genomic information will likely drive companies in these industries to provide new personalized products and services. However, the future is uncertain, and changing conditions could trigger alternative outcomes. Some examples of potential events that could transform the future of precision-medicine development follow:
- Direct-to-consumer genetic testing's becoming pervasive for improving personal health. Services that offer direct-to-consumer (DTC) genetic testing will continue to increase in number, providing consumers with DNA tests concerning their heritage and, more controversially, their risks for certain health issues. DTC genetic tests will likely proliferate outside health care, not only providing consumers with knowledge about their disease risk but also giving them information about their bodies' tolerances to foods and responses to various forms of exercise.
- Policy makers' relaxing of regulations surrounding experimental therapies because of do‑it-yourself gene-editing kits and biohacking. Biohacking could influence right-to‑try laws to extend to individuals who are not terminally ill. Conversely, regulators and authorities could strictly restrict individuals' access to experimental therapies. Authorities' restricting access to experimental therapies in this way could lead to a black market for gene-editing tools and various biohacking therapies. If such clandestine biohacking yields positive results, regulators could feel pressure to investigate and expedite clinical trials of these therapies.
- Wearables' becoming increasingly affordable. Wearables are easier to use than are laboratory-based tests. The increasing affordability of wearables may significantly affect the adoption of other precision-medicine technologies (such as DNA‑sequencing technologies, lab‑on-a‑chip technologies, and nanodiagnostic platforms).