Enzolve Technologies, a UCD spin-out company, will launch a novel newborn screening test for phenylketonuria (PKU) later this week following the granting of the CE Mark. 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 prior to it being granted the CE Mark.
Enzolve Technologies, based at NovaUCD the Innovation and Technology Transfer Centre, has designed and developed its novel diagnostic test over the past 2-years. The test will be formally launched at the 6th ISNS European Regional Meeting in Neonatal Screening which takes place in Prague, the Czech Republic from April 26th – 28th. Enzolve 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.
Phenylketonuria (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.
The PKU test is the first in a suite of products, called NeoScreenPak, which Enzolve Technologies is developing to screen for a variety of metabolic disorders in babies. Enzolve’s NeoScreenPak offers several key advantages over other available screening methods. All of the NeoScreenPak tests are based on a single-format technology and are simpler, faster, more reliable, convenient and cost-effective than tests currently available on the market.
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.”
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.
