Clinical diagnostics — the testing, analysis, and monitoring of human specimens to detect, diagnose, and manage disease — is one of the largest and fastest-growing segments of the global healthcare market. The field encompasses everything from a standard complete blood count to a next-generation sequencing panel identifying rare mutations in a tumor biopsy. What unifies…
Cancer testing does not work the way most people expect. There is no test a physician orders that comes back with a definitive yes or no — no result that tells a patient, with certainty, whether cancer is present or absent. Instead, diagnosis unfolds across a workflow of accumulating evidence: screening signals that flag elevated…
A companion diagnostic is a test that is developed, validated, and often co-approved alongside a specific therapeutic drug to identify patients who are likely to respond to that drug — and, equally importantly, to identify those who are not. The defining characteristic of a companion diagnostic is that its clinical use is inseparable from a…
A liquid biopsy is a test that analyzes genetic material or cellular components circulating in body fluids — most commonly blood — to detect, characterize, or monitor disease. The term is most closely associated with cancer diagnostics, where it has emerged as a powerful complement and, in certain contexts, an alternative to surgical tissue biopsy….
Exosomes are nanoscale vesicles — tiny membrane-enclosed particles, typically between 30 and 150 nanometers in diameter — that are secreted by virtually every cell type in the human body. They were once dismissed as cellular refuse: vesicles that cells used to expel unwanted material. The scientific consensus has shifted dramatically. Exosomes are now understood to…
Clinical laboratories in the United States operate under a layered regulatory framework that involves two distinct federal agencies with overlapping but non-identical authority over different aspects of laboratory testing. The Centers for Medicare & Medicaid Services (CMS) regulates laboratories themselves — the facilities, personnel, quality systems, and operational standards that govern how tests are performed….
Genomics is the field of study concerned with the complete set of an organism’s genetic material — its genome — and how that genetic information is structured, expressed, and regulated. Where genetics traditionally focused on the function of individual genes, genomics takes a systems-level view, examining how the entire genome operates, interacts, and produces the…