Enzolve Technologies, a UCD spin-out company, has formally launched its first CE-marked diagnostic test which screens for PKU (phenylketonuria) in newborn babies. Enzolve’s PKU test, based on engineered enzyme technology, has several advantages over the tests currently available on the market. It is easier, faster and more convenient to use and the results are more reliable.
The Enzolve PKU kits are also more cost effective and are available in two formats containing sufficient materials to allow up to 400 or 1,000 newborns to be tested. The products were launched at the 6th ISNS European Regional Meeting in Neonatal Screening which took place last week in Prague, the Czech Republic.
Enzolve Technologies' novel newborn screening test kit for PKU
PKU is an inherited metabolic disorder that results in severe mental retardation if treatment is not started within the first few weeks of life. If the disorder is detected early, and with a well-maintained appropriate diet, affected children can have normal development and life span. While most developed countries have programmes to screen newborns for this disorder, only 30-35% of babies world-wide undergo such screening programmes.
Enzolve Technologies, based at NovaUCD the Innovation and Technology Transfer Centre at UCD, has designed and developed its novel diagnostic test over the past 2 years. The company was co-founded by Professor Paul C. Engel and Dr Suren Aghajanian as a spin-out from UCD’s School of Biomolecular and Biomedical Science. The PKU test is the first in a suite of products, called NeoScreenPak, which Enzolve is developing to screen for a variety of metabolic disorders in babies.
Speaking in advance of the formal product launch Professor Philip Mayne, Director of the National Newborn Screening Laboratory at the Children’s University Hospital, Dublin, said that “…this is a significant advance for Enzolve and has potential for newborn screening around the world. The product is very suitable for countries that cannot invest in advanced screening equipment, allowing these countries to implement national screening programmes for PKU.”
Enzolve’s PKU test underwent extensive evaluation by the National Standard Authority of Ireland on behalf of the Irish Medicines Board to assure that best practice was undertaken in the design and development of the product which resulted in it being granted the CE Mark. In addition to the granting of the CE Mark, Enzolve Technologies was also recently awarded ISO 13485:2003 accreditation, demonstrating its commitment to quality and customer service.
ENDS
May 7 2009
For further information contact Micéal Whelan, NovaUCD, e: miceal.whelan@ucd.ie, t: (01) 716 3712.
Editor’s Notes
Enzolve Technologies is commercialising genetically engineered enzymes and enzyme-based specialty products. The company is a spin-off company from UCD’s School of Biomolecular and Biomedical Science and was co-founded by Professor Paul C. Engel and Dr Suren Aghajanian.
NovaUCD is University College Dublin’s Innovation and Technology Transfer Centre. Twenty-five knowledge-intensive companies including Enzolve Technologies are currently located in NovaUCD. NovaUCD has been funded through a unique public-private partnership that includes AIB Bank, Arthur Cox, Deloitte, Enterprise Ireland, Ericsson, Goodbody Stockbrokers, UCD and Xilinx.
