Diagnostics

Diagnostics refers to the investigation and identification of disease states in medicine. The modern diagnostic industry generally falls into two broad categories: in vitro diagnostics (from the Latin meaning “in glass”) and in vivo diagnostics (from the Latin meaning “in the living”). In vitro diagnostics involves the removal samples of tissue such as blood, saliva, biopsy samples from a living organism for examination in the laboratory setting, whereas in vivo diagnostics involves observing and testing tissue and function in a living organism—techniques such as medical imaging (x-rays, magnetic resonance, computed tomography, etc.) and monitoring like electrocardiography, electroencephalography, etc.).

The in vitro diagnostics industry is a near $50 billion sector that includes the manufacture of tests ranging from over-the-counter at-home kits, such as pregnancy tests, to highly sophisticated molecular (or nucleic acid) tests. In addition to the test elements (the reagents), the laboratory market that the IVD industry serves also includes sales of the equipment used to handle and analyze results. These systems include automated and high-throughput analyzers and readers to assist in handling the large volume of tests that typical hospitals and reference labs.

The medical imaging sector is a technology-intensive area of diagnostics that has traditionally been consolidated in the hands of a few large corporations. The sector is driven by innovation in both equipment (miniaturization, portability, integration with IT infrastructures) and in clinical and research application. Improvements in computer enhancement and in new contrast media as well as the advent of high-tech molecular imaging techniques has broadened the range of conditions that in vivo imaging can address.