Personalized medicine
While the tailoring of treatment to patients dates back at least to the time of Hippocrates, the usage of the term has risen in recent years thanks to the development of new diagnostic and informatics approaches that provide an understanding of the molecular basis of disease, particularly genomics.
[4][5] In personalised medicine, diagnostic testing is often employed for selecting appropriate and optimal therapies based on the patient's genetics or their other molecular or cellular characteristics.
[9][10] In precision medicine, diagnostic testing is often employed for selecting appropriate and optimal therapies based on the context of a patient's genetic content or other molecular or cellular analysis.
For example, personalised techniques such as genome sequencing can reveal mutations in DNA that influence diseases ranging from cystic fibrosis to cancer.
[citation needed] The ability to provide precision medicine to patients in routine clinical settings depends on the availability of molecular profiling tests, e.g. individual germline DNA sequencing.
[36] While precision medicine currently individualizes treatment mainly on the basis of genomic tests (e.g. Oncotype DX[37]), several promising technology modalities are being developed, from techniques combining spectrometry and computational power to real-time imaging of drug effects in the body.
[38] Many different aspects of precision medicine are tested in research settings (e.g., proteome, microbiome), but in routine practice not all available inputs are used.
[39][40][41] Early studies applying omics-based precision medicine to cohorts of individuals with undiagnosed disease has yielded a diagnosis rate ~35% with ~1 in 5 of newly diagnosed receiving recommendations regarding changes in therapy.
[49] Machine learning algorithms are used for genomic sequence and to analyze and draw inferences from the vast amounts of data patients and healthcare institutions recorded in every moment.
[50] AI techniques are used in precision cardiovascular medicine to understand genotypes and phenotypes in existing diseases, improve the quality of patient care, enable cost-effectiveness, and reduce readmission and mortality rates.
In addition, benefits are to:[citation needed] Advances in personalised medicine will create a more unified treatment approach specific to the individual and their genome.
The detailed account of genetic information from the individual will help prevent adverse events, allow for appropriate dosages, and create maximum efficacy with drug prescriptions.
Due to warfarin's significant interindividual variability in pharmacokinetics and pharmacodynamics, its rate of adverse events is among the highest of all commonly prescribed drugs.
[72] These companion diagnostics have incorporated the pharmacogenomic information related to the drug into their prescription label in an effort to assist in making the most optimal treatment decision possible for the patient.
Having a detailed account of an individual's genetic make-up can be a major asset in deciding if a patient can be chosen for inclusion or exclusion in the final stages of a clinical trial.
Several drug discovery and pharmaceutical companies are currently utilizing these technologies to not only advance the study of personalised medicine, but also to amplify genetic research.
Though not necessarily using genetic information, the customized production of a drug whose various properties (e.g. dose level, ingredient selection, route of administration, etc.)
are selected and crafted for an individual patient is accepted as an area of personalised medicine (in contrast to mass-produced unit doses or fixed-dose combinations).
[citation needed] One active area of research is efficiently delivering personalized drugs generated from pharmacy compounding to the disease sites of the body.
[5] For instance, researchers are trying to engineer nanocarriers that can precisely target the specific site by using real-time imaging and analyzing the pharmacodynamics of the drug delivery.
[8] Alteration of surface chemistry allows these nanoparticles to be loaded with drugs, as well as to avoid the body's immune response, making nanoparticle-based theranostics possible.
[78] Despite the great potential of this nanoparticle-based drug delivery system, the significant progress in the field is yet to be made, and the nanocarriers are still being investigated and modified to meet clinical standards.
For example, in a study conducted by Lazzari et al. in 2012, the proteomics-based approach has made substantial improvement in identifying multiple biomarkers of lung cancer that can be used in tailoring personalized treatments for individual patients.
Examples of this include: Through the use of genomics (microarray), proteomics (tissue array), and imaging (fMRI, micro-CT) technologies, molecular-scale information about patients can be easily obtained.
[94] Combining molecular scale information with macro-scale clinical data, such as patients' tumor type and other risk factors, significantly improves prognosis.
[100] Additionally, while polygenic scores have some predictive accuracy, their interpretations are limited to estimating an individual's percentile and translational research is needed for clinical use.
The current approaches to intellectual property rights, reimbursement policies, patient privacy, data biases and confidentiality as well as regulatory oversight will have to be redefined and restructured to accommodate the changes personalised medicine will bring to healthcare.
[citation needed] The U.S. Food and Drug Administration (FDA) has started taking initiatives to integrate personalised medicine into their regulatory policies.
This is because the sample was tested only on white people and when applied to the non-white population, the results were biased with overestimation and underestimation risks of cardiovascular disease.
This is not only due to the infrastructure and technology required for a centralized database of genome data, but also the physicians that would have access to these tools would likely be unable to fully take advantage of them.
