California-based diagnostics firm Intrinsic LifeSciences (ILS) scored a $4.45 million NIH grant for its Phase II-B SBIR project dubbed “Serum Hepcidin Immunoassay: Laboratory to Marketplace.” ILS plans to use the newly acquired funds to manufacture the Intrinsic Hepcidin Index™ in vitro diagnostic. It also intends to perform a clinical study aimed at validating the Hepcidin Index test for the differential diagnosis of iron refractory iron deficiency anemia (IRIDA), a recently discovered genetic iron disorder, from other acquired types of microcytic anemia. The study will be conducted at Boston Children’s Hospital under the direction of pathologist-in-chief Mark D. Fleming, M.D., D. Phil.

Hepcidin, according to ILS, is the regulatory hormone that controls dietary iron absorption and circulating plasma iron concentrations needed for normal blood production in the bone marrow. Abnormally high hepcidin is linked to the anemia seen in rheumatoid arthritis and other conditions, and high serum hepcidin levels are also implicated in discovered IRIDA. ILS says the clinical characteristics of IRIDA in patients are similar to those in anemic pediatric and adolescent patients without IRIDA, making the condition difficult to diagnose with current tests. The firm hopes the Hepcidin Index test—intended to diagnose IRIDA without genetic testing and help clinicians choose iron therapies for patients with genetic or acquired anemias—will fix that.

“This study represents a major milestone toward generating pivotal data supporting hepcidin hormone testing in anemic patients and the commercialization of a diagnostic test using our monoclonal antibodies to hepcidin,” Mark Westerman, CEO of ILS and the study's principal investgator, said in a statement.

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