US-based life science companies Calbiotech and Intrinsic LifeSciences (ILS) have entered into a partnership to develop and validate ELISA kits for hepcidin, a hormone that acts as an indicator of iron disorders.
Hepcidin is a peptide produced in the liver that has been identified by researchers in the last decade as the sole hormone regulator of iron levels in the blood.
As part of the deal, Calbiotech will be responsible for producing prototype Intrinsic Hepcidin ELISA kits for technical and clinical validation studies.
Calbiotech vice president David Barka said: "Calbiotech has established a reputation providing innovative, high quality contract manufacturing services that provides the flexibility to accommodate the needs of our partners.
"The strategic partnership with Intrinsic allows us to combine our quality manufacturing expertise with ILS’s experience as pioneers of hepcidin testing; we are a natural fit for the project."
Hepcidin regulates iron absorption and recycling in the body in order to maintain a critical balance of plasma iron, which is important to maintain health.
About 15% of children aged one to two years and nearly 10% in women aged 12 to 49 years are iron deficient.
Both low and high hepcidin levels are often associated with chronic and life-threatening health issues.
According to the companies, the successful development of prototype Intrinsic Hepcidin kits and technical evaluation will lead to a manufacturing agreement between them and pave the way for distribution in select markets of CE Mark Intrinsic Hepcidin ELISA kits, targeted for the fourth quarter of 2014.
Intrinsic LifeSciences president and CEO Mark Westerman said: "We are impressed with Calbiotech’s ability to deliver quality prototypes to meet our stringent specifications that are suitable for final performance evaluation.
"Since development and publication of the first human serum hepcidin assay in 2008, we have focused on discovering high affinity monoclonal antibodies (mAbs) to bioactive hepcidin with NIH SBIR support and recently were successful in developing a small suite of mAbs directed to hepcidin.
"These mAbs will help advance clinical testing of serum hepcidin for assessing iron disorders and inflammatory diseases. In working with Calbiotech, we can manufacture and deliver high-quality hepcidin products that our customers around the world expect from ILS."
Calbiotech specialises in ELISA and ultrasensitive chemiluminescent assays, providing more than 200 ready-to-use serum, saliva and research animal ELISA kits.