[July 31, 2014]

Calbiotech and Intrinsic LifeSciences Announce Development Agreement for ELISA Test Kit for Hepcidin

Life science companies Calbiotech, Inc. and Intrinsic LifeSciences™ (ILS) today announce a partnership to develop and validate ELISA kits for hepcidin, a hormone that plays a central role in the regulation of iron in the blood and indicator of iron disorders. Under the agreement, Calbiotech will produce prototype Intrinsic Hepcidin™ ELISA kits for technical and clinical validation studies.

"Calbiotech has established a reputation providing innovative, high quality contract manufacturing services that provides the flexibility to accommodate the needs of our partners," said David Barka, Vice President of Calbiotech. "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."

"We are impressed with Calbiotech's ability to deliver quality prototypes to meet our stringent specifications that are suitable for final performance evaluation," said Mark Westerman, Ph.D., President and CEO of ILS. "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 ustomers around the world expect from ILS."

Hepcidin, a peptide produced in the liver, has been identified in the last decade as the sole hormone that regulates iron levels in the blood. Hepcidin regulates iron absorption and recycling in the body to maintain a critical balance of plasma iron that is important to maintain health. Nearly 15% of children age 1 - 2 years, and nearly 10% in women aged 12 - 49 years are iron deficient. Both low and high hepcidin levels are frequently associated with chronic and life threatening health issues. Successful development of prototype Intrinsic Hepcidin kits and technical evaluation will lead to a manufacturing agreement between Calbiotech and ILS and open discussion for distribution in select markets of CE Mark Intrinsic Hepcidin ELISA kits targeted for Q4 2014. Both companies are exhibiting their products and services at the American Association of Clinical Chemistry (AACC) meeting in Chicago this week at Calbiotech booth #3542.

About Calbiotech

Calbiotech, Inc., a San Diego-based company established in 1998, specializes in ELISA and Ultrasensitive chemiluminescent assays offering more than 200 ready-to-use serum, saliva and research animal ELISA kits. Calbiotech custom develops and manufactures immunoassay products according to ISO 13485 and cGMP standards that are used by major reference labs, universities and research centers around the world. The company's growing holdings include Moduline Systems and Calbiotech Veterinary Diagnostics. For more information, please visit www.calbiotech.com.

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., (David Geffen School of Medicine) are pioneers in the discovery of hepcidin, describing hepcidin's regulatory pathways, diagnostics development, 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™ later in 2014. Learn more at www.intrinsiclifesciences.com and at PubMed.

Intrinsic LifeSciences and the BioIron Company are trademarks of Intrinsic LifeSciences, Inc.

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