AN ON-SITE STRIP TEST FOR SCREENING OF PHENYLKETONURIA

PHENYLALANINE IS THE METABOLITE THAT ACCUMULATES IN PHENYLKETONURIA (PKU), A GENETIC DISORDER. UNDETECTED, PHENYLKETONURIA IN NEWBORNS CAN RESULT IN BRAIN DAMAGE AND BEHAVIORAL PROBLEMS. CURRENT TESTS TO DETECT THIS SEVERE DISEASE ARE CONDUCTED IN ONLY A FEW LABORATORIES, ANDTHERE ARE UNAVOIDABLE DELAYS IN RECEIVING TEST RESULTS. THEREFORE, A STRIP TEST FOR QUICK ON-SITE DETERMINATION OF PHENYLALANINE LEVELS IN BLOOD WILL BE A VALUABLE TOOL FOR BOTH THE DETECTION AS WELL AS MONITORING OF PHENYLKETONURIA. GDS TECHNOLOGY, INC., HAS RECENTLY DEVELOPED A SPECIFIC THERMOSTABLE PHENYLALANINE DEHYDROGENASE THAT FORMS THE BASIS FOR THE STRIP TEST. IN PHASE I, FEASIBILITY RESEARCH WILL FOCUS ON THE DEVELOPMENT OF A VISUAL STRIP TEST BY INCORPORATING THE PHENYLALANINE DEHYDROGENASE ENZYME AND AN INDICATOR SYSTEM THAT WILL PRODUCE COLOR PROPORTIONATE TOTHE SERUM CONCENTRATION OF PHENYLALANINE. THE GOAL OF PHASE II IS TO COMPLETE THE DEVELOPMENT OF A WHOLE-BLOOD STRIP TEST AND TO PERFORM CLINICAL TRIALS. THE PROGRAM IS ATTRACTIVE AS IT OFFERS THE OPPORTUNITY TO ENHANCE PREVENTIVE MEDICAL CARE BY PROVIDING ACCURATE ON-SITE ANSWERS. BECAUSE OF ITS SIMPLICITY, THE TEST COULD BE PERFORMED EVEN IN UNDERDEVELOPED COUNTRIES.