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Press Release: Abnova and IQ Products Advance the Development of BK Virus Diagnostics

Press Release: Abnova and IQ Products Advance the Development of BK Virus Diagnostics

Abnova and IQ Products Advance the Development of BK Virus Diagnostics

Neihu, Taiwan and Groningen, Netherlands (April 1, 2010).

Abnova and IQ Products Corporation have entered into a collaboration agreement today to advance the development and commercialization of BK virus diagnostics for the in vitro diagnostics (IVD) market. Under this partnership, Abnova has licensed its proprietary BK virus monoclonal antibodies and hybridomas to IQ Products for validation and development of several BK virus-based diagnostics and exclusive sales rights in Europe. IQ Products has also been granted an exclusive manufacturing right of BK virus diagnostics for the European and Asian Pacific markets. IQ Products aims to complete a CE mark IVD approval in Europe within two years while Abnova is responsible for the regulatory approval in Asia Pacific. Both companies will then establish further partnership for the greater US market.

BK virus, a member of the Polyomavirus, has been increasingly recognized as a major contributor to nephropathy in post-kidney transplantation and immunosuppressed patients. In normal individuals, BK virus is dormant in the kidney, urinary ducts, and lymphoid tissues while in immunosuppressed individuals, the virus then becomes reactivated thereby offsetting the normal cellular physiology and kidney function. The current PCR diagnostic tests for BK virus are not satisfactory as the virus DNA is highly prevalent in normal population and is susceptible to subjective virus threshold determination which constitutes an active infection. Antibody-based in vitro diagnostics enables direct detection of BK virus in kidney cells, tissue, and urine and allows therefore a better diagnosis of active disease and monitor of severity of infection.

Abnova has produced a comprehensive collection of monoclonal antibodies and hybridoma clones targeting both cell surface and intracellular protein of BK virus. “We are very enthusiastic of our partnership with IQ Products, a leading developer of in vitro diagnostic for a number of human diseases including cytomegalovirus infection, a concurrent culprit in post-kidney transplant related nephropathy and immunosuppression,” stated Wilber Huang, MD, President and CEO of Abnova. “There is much validation work required before a larger-scale patient trial prior to an IVD approval.” By working together, Abnova can shorten the developmental cycle while accelerating the commercialization process by leveraging IQ Products’ expertise in the regulatory affairs and well-established sales and marketing infrastructure.

”The development of BK virus diagnostics is an excellent contribution to IQ Product’s transplantation diagnostics area,” confirms Dr. Roland Lageveen, CEO of IQ Products BV. “Abnova contributes top of the line antibodies and clones and is a much preferred partner for the development and commercialization of antibody based diagnostics. We are very pleased with the joint effort and confident that the collaboration will contribute to better diagnostics and subsequent treatment.”

About Abnova
Abnova is a biotech company specializing in high throughput protein expression and antibody production. The system Abnova has developed is a unique combination of world-class technologies and management experience of the IT industry in Taiwan. The company's goal is to vastly expand the scope and availability of bio-tool reagents. As such, it is a taking a genome-wide approach to the production of human recombinant protein and antibody, and is developing a portfolio of integrated and systemized applications including antibody pairs, ultra-sensitive protein quantification and high content screening assays covering protein families that are essential to the drug discovery and diagnostic industries. (www.abnova.com)

About IQ Products
IQ Products B.V. is a global supplier of a range of products for perinatal, transplantation and sepsis related diagnostics and routine flow cytometry. IQ offers certified innovative assays for in vitro diagnostics worldwide. IQ Products is the diagnostic division of IQ Corporation B.V. (www.iqproducts.nl)
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