Novel newborn screening test for PKU developed by NovaUCD-based Enzolve Technologies. (Photo by Nick Bradshaw)
Enzolve Technologies, a UCD spin-out company, is to launch a novel newborn screening test for phenylketonuria (PKU) following the granting of the CE Mark. Enzolve’s PKU test 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 prior to it being granted the CE Mark.
Enzolve Technologies, based at NovaUCD, has designed and developed its novel diagnostic test over the past two years. The test will be formally launched at the 6th ISNS European Regional Meeting in Neonatal Screening which takes place in Prague later this month.
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.
Speaking in advance of the formal product launch Prof Philip Mayne, Director of the National Newborn Screening Laboratory at the Children’s University Hospital, Dublin, 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.’
Enzolve was co-founded by Prof 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 the NeoScreenPak suite of products, which Enzolve Technologies is developing to screen for a variety of metabolic disorders in babies.
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