[July 29, 2014]

NIH Awards Intrinsic LifeSciences™ $4.45 Million SBIR Phase II-B Funding for a Diagnostic Test for the Differential Diagnosis of Anemias with the Iron Regulatory Hormone, Hepcidin

Intrinsic LifeSciences™ (ILS) is a privately held diagnostics company focused on developing novel hepcidin diagnostic tests, iron biomarker panels, and algorithms for genetic and acquired iron and inflammatory diseases. Today, ILS announced it has been awarded a $4.45 million grant from the National Institutes of Health for its Phase II-B Small Business Innovation Research project entitled, "Serum Hepcidin Immunoassay: Laboratory to Marketplace." With the pre-commercialization funding, ILS will establish cGMP/ISO compliant manufacturing of the Intrinsic Hepcidin Index™ in vitro diagnostic, and perform a prospective clinical study at Boston Children's Hospital under the direction of Mark D. Fleming, M.D., D. Phil. (Pathologist-in-Chief). The study aims to clinically validate the Hepcidin Index test for the differential diagnosis of a recently discovered genetic iron disorder, Iron Refractory Iron Deficiency Anemia (IRIDA), from other acquired forms of microcytic anemia.

"We are extremely pleased that NIH has recognized the potential of the Hepcidin Index test for clinical medicine by deciding to fund our pre-commercialization efforts and clinical study," said Principal Investigator Mark Westerman, CEO of ILS. "This study represents a major milestone towards generating pivotal data supporting hepcidin hormone testing in anemic patients and the commercialization of a diagnostic test using our monoclonal antibodies to hepcidin. The Hepcidin Index test is intended to enable the raid diagnosis of IRIDA without expensive genetic testing or extensive clinical work-ups, and to guide the choice of iron therapies for patients with genetic or acquired anemias."

Hepcidin is the master regulatory hormone that controls dietary iron absorption and circulating plasma iron concentrations essential for normal blood production in the bone marrow. Abnormally low or high blood hepcidin levels are associated with debilitating genetic and chronic human disease that include iron overload diseases or iron-restricted anemias. A low hepcidin is a hallmark of hereditary hemochromatosis, a genetic iron overload disease, and paradoxically, iron deficiency and iron deficiency anemia. Abnormally high hepcidin is the key pathological factor in anemia of inflammation seen in rheumatoid arthritis, chronic infections, cancers, and CKD. High serum hepcidin levels are also implicated in discovered IRIDA. Clinical characteristics of IRIDA patients are similar to anemic pediatric and adolescent patients without the disease and current tests for these conditions lack sufficient sensitivity for diagnosis and therapeutic choices for treatment of IRIDA. The Hepcidin Index test promises to address this unmet need.

About Intrinsic LifeSciences

Intrinsic LifeSciences, The BioIron Company™, is a privately held California-based company focused on developing innovative tests that help improve the diagnosis and treatment of patients with life-threatening diseases. The company founders, Mark Westerman, Ph.D. and Professors Tomas Ganz, Ph.D. M.D., and Elizabeta Nemeth, Ph.D., (UCLA David Geffen School of Medicine) are pioneers in the discovery of hepcidin, describing hepcidin's regulatory pathways, diagnostics, and identifying its clinical potential in several iron-related diseases. The company will offer hepcidin testing through its CAP/CLIA accredited laboratory, IntrinsicDx, The BioIron Laboratory™ in late 2014. Learn more at www.intrinsiclifesciences.com and our new IntrinsicDx website www.intrinsicDx.com.

Research reported in this publication has been supported by the National Institute of Diabetes and or Digestive and Kidney Diseases of the National Institutes of Health under Awarded Number R44DK083843. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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