The world of medicine continues to expand through groundbreaking advances and the latest mechanisms to cure and treat diseases. An approach that continues to surface is a technique called Precision Medicine, an advancement that aims to treat diseases based on the individual carrier.

According to the Precision Medicine Initiative, this technique is “an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person.” This advancement could allow researchers and other medical professionals to more accurately treat a disease based on the individual, as opposed to the conventional one-size-fits-all form of current interventions.

In 2015, former President Barack Obama announced the Precision Medicine Initiative, intended to revolutionize the improvement of health and research for treating diseases. Precision Medicine combines different fields, like metabolomics, genomics and biomedical data sciences, while also facilitating technologies in the process, such as artificial intelligence (AI), imaging and networking.

The UC Davis Precision Medicine Model summarized this technique’s initiative to be an “intersection between people, their environment, the changes in their markers of health and illness, and their social and behavioral factors over time.”

This form of care will require accurate testing to guide this individualized treatment formality. According to the Food and Drug Administration (FDA), Next Generation Sequencing (NGS) tests are “capable of rapidly identifying or ‘sequencing’ large sections of a person’s genome and are important advances in the clinical applications of precision medicine.” As researchers and physicians utilize these tests to determine genetic variants, it will promote an understanding of diseases and how to best treat them in an individualized scope.

However, the NGS does create regulatory issues for the FDA. The current regulatory mechanisms are meant for conventional diseases, meaning that they can detect a single condition or disease. The FDA describes these tests as “contain[ing] the equivalent of millions of tests in one.” This has caused the FDA to work with laboratories, academia, stakeholders and patient and professional societies to accommodate this expansion of technology.

As of 2018, the FDA has recommended two guidelines for Precision Medicine, including the submission and review of data to analyze the validity of NGS-based tests. Through these recommendations, the FDA aims to provide an “efficient and flexible oversight approach: as technology advances, standards can rapidly evolve and be used to set appropriate metrics for fast growing fields…”

As this form of “personalized medicine” continues to expand, it has already led to discoveries and FDA-approved treatments designed for specific characteristics.

Currently, Precision Medicine has been most effectively used during the COVID-19 pandemic with its various biomarkers, like the c-reactive protein which assesses the severity of the disease while analyzing the efficacy of vaccines. This mechanism is also “finding its place in management of infectious diseases, chronic diseases such as asthma, connective tissue diseases, cardiovascular diseases, diabetes and obesity,” according to PubMed Central.

Precision Medicine in oncology is taking a stance against the conventional methods of chemotherapy and radiation. As the patients normally have negative side effects to these treatments, like the loss of hair follicles or damage to the intestinal tract cells, Precision Medicine may propose a conventional treatment option. “Targeted therapy or precision oncology aims to mitigate the conventional adverse effects of chemotherapy, maintaining the effect on the cancer cell, utilizing target identification at extracellular level, cell membrane level, intracellular level and intranuclear level,” PubMed Central stated.

As this technology continues to evolve, numerous challenges affect its ability to expand further. The issues regarding costs, ethics and the availability of trained professionals to manage the data and algorithms are limited.

As this “new age medicine” progresses, it will hopefully bring more future benefits to patients and their caregivers.