Iron is essential for every living organism. It is a key component of blood hemoglobin, energy-generating enzymes, and other building blocks of life. The recently discovered hormone, hepcidin, controls the absorption and distribution of iron in the body. Hepcidin diagnostics and hepcidin-targeting drugs will revolutionize the medical management of anemias and iron overload diseases.

Prevalence of Iron Diseases. The prevalence of all types of anemia is staggering with ~1 billion humans worldwide affected at any time. Additionally, hereditary hemochromatosis (genetic iron overload disease) occurs in 10M patients worldwide. Iron-loading anemias such as beta-thalassemia affect another 15M patients. Hepcidin concentrations are altered in all these disorders and are expected to provide useful diagnostic and prognostic information.

Current diagnostic tests for iron status (serum ferritin, serum iron, transferrin saturation) do not provide adequate information in many diseases. Key markets for our hepcidin IVDs may include patients with anemia where hepcidin can be used to differentiate between iron deficiency anemias (IDA) and anemia of inflammation (AI). In hereditary hemochromatosis, hepcidin can differentiate those patients that need lifelong treatments from others whose disease is so mild that it does not require treatment. In iron-loading anemias, hepcidin will be a prognostic tool to gauge the severity of the disease and its complications, and to assess the effectiveness of therapies. Iron deficiency and inflammation contribute to cancer- and chemotherapy-induced anemia (CIA; ~6- 8M WW, 60% anemic) and chronic kidney disease anemia (CKD; pre-dialysis 2M WW: 40% anemic; dialysis 700,000 WW: 90% anemic). ILS hepcidin IVDs could be used routinely to monitor iron status in CIAs and CKD patients over many years, and assess the effectiveness of EPO, anti-inflammatory, and dialysis therapies.