U.S. Markets for Diagnostic Oncology Products

Significant advancements in the field of molecular medicine in recent years have allowed researchers to study the chromosomal/genetic alterations that trigger the transformation of normal cells into malignant cells, and it has been determined that changes in the cellular genome underlie all forms of cancer, of which there are more than 100. Cancer cells may remain localized for long periods, but eventually most types of human tumor masses generate pioneer cells that invade adjacent tissues and metastasize to vital organs, such as the brain, liver, or lungs. As malignant cells proliferate and crowd normal cells in the tissues of an organ, structural obstructions form, competition for nutrients and space increases, and if the condition is left untreated, the invaded tissues begin to malfunction, disrupting the workings of organs and then entire organ systems (nutritive and physical strangulation of invaded tissues/organs represents the primary cause of death in most fatal cancer cases).

When a normal cell transforms into a cancer cell, its self-control and repair mechanisms fail as alterations in the genome adversely affect the production of proteins that control these processes; subsequently, the mutation rate of the cell is accelerated, producing a tumor that is a collection of cells with wildly diverse genomes instead of identical clones. This production of diverse cell collections within a single tumor is one of the reasons that cancer is so difficult to treat. Treatment regimens that may eradicate one cell type may not work against another cell type, a scenario to which is added the problem of drug-resistant variant cell emergence. Many risk factors have been identified for the development of cancer, some of which include advancing age (more than 75% of cancers are diagnosed in adults who are age 55 or older); being overweight and/or physically inactive; drinking alcohol; infection with certain microbes; smoking tobacco; and sustaining exposure to radiation (including that from the sun) or to toxic substances such as benzene and carbon tetrachloride.