Human Genomics Projections for the Future

At school science fairs, studies involving the analysis of genome sequences and related phenotypic data for millions of human participants will be regularly featured.

FREMONT, CA: Since the Human Genome Project began 30 years ago, genomics has become profoundly ingrained in research, medicine, and, increasingly, everyday life. In less than 10,000 days, genomics has evolved from a niche discipline synonymous with a moonshot mission to a scientific field that is now critical in areas as diverse as microbiology and oncology.

Noninvasive prenatal genetic testing, DNA-based forensics, direct-to-consumer ancestry sleuthing, genetic disease diagnostics, and SARS-CoV-2 virus surveillance are only a few examples of genomic applications. So, what's next for genomics, especially in terms of human health and disease applications?

Bold Human Genomics Projections By 2030

Fundamentally, the level of validation and formalization required depends on the assay's suitability for its intended intent.  Method validation is a time-consuming process, but if done incorrectly, it may result in a waste of money and energy, as well as incorrect scientific knowledge. Assay methods are designed to measure pharmaceuticals and their metabolites, endogenous compounds, peptides, and proteins in various biological matrices in bioanalysis, including universities, federal agencies, and Contract Research Organizations (CROs), hospitals, and the pharmaceutical industry.

Novel analytical approaches and workflows are investigated in an academic setting to enhance sensitivity, minimize cost, and increase the throughput of analysis or analytical methods  regulate medication quality and track drug misuse or environmental exposure. The FDA guidance's goal is to help sponsors of Investigational New Drug applications (INDs) or applicants of New Drug Applications (NDAs) validate bioanalytical methods used in human or animal research, or biomarker concentration evaluation, by ensuring sound scientific principles and paying close attention to quality assurance and quality control.

Novel analytical approaches and workflows are investigated in an academic setting to enhance sensitivity, minimize cost, and increase the throughput of analysis or analytical methods developed to support research programs. Pharmaceutical companies and CROs validate assays for use in drug discovery and development, while in hospitals, analytical techniques are used to improve drug treatment. Government agencies require assay methods to regulate medication quality and track drug misuse or environmental exposure. The FDA guidance's goal is to help sponsors of Investigational New Drug applications (INDs) or applicants of New Drug Applications (NDAs) validate bioanalytical methods used in human or animal research, or biomarker concentration evaluation, by ensuring sound scientific principles and paying close attention to quality assurance and quality control.