A ground-breaking newborn screening test for phenylketonuria (PKU) will be launched by NovaUCD-based Enzolve Technologies later this week, following the granting of the CE Mark.
Enzolve Technologies, which is based at NovaUCD and is a spin-out from UCD’s School of Biomolecular and Biomedical Science, has designed and developed its novel diagnostic test over the past two years.
The test will be formally launched at the 6th International Society for Neonatal Screening (ISNS) European Regional Meeting in Neonatal Screening, which takes place in Prague from 26–28 April 2009.
Enzolve’s PKU test was granted the CE Mark after it underwent extensive evaluation by the National Standards 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.
PKU is an inherited metabolic disorder that results in severe mental retardation, if treatment is not started within the first few weeks of life.
When the disorder is detected early, and with a well-maintained appropriate diet, affected children can experience normal development and a normal life span.
While most developed countries have programmes to screen newborns for this disorder, only 30-35pc of babies globally currently 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.
Speaking in advance of the formal product launch, Professor Philip Mayne, director of the National Newborn Screening Laboratory at the Children’s University Hospital, Temple Street, said: “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,” he added.
For further information on this week’s neonatal event in Prague, visit the ISNS website
By Carmel Doyle
Pictured: Novel newborn screening test for PKU, which will be launched later this week by NovaUCD-based Enzolve Technologies