AN ON-SITE STRIP TEST FOR SCREENING OF GALACTOSEMIA

CHILDREN SUFFERING FROM GALACTOSEMIA, A GENETIC DISORDER, DO NOT HAVE THE ABILITY TO DIGEST MILK AND ACCUMULATE GALACTOSE IN BLOOD. GALACTOSEMIA LEADS TO CATARACTS, MENTAL RETARDATION, LIVER AND RENAL DAMAGE, AND EVEN DEATH. BECAUSE OF ITS SEVERITY, IN MOST DEVELOPED COUNTRIES NEWBORNS ARE SCREENED FOR GALACTOSEMIA IN ADDITION TO PHENYLKETONURIA. HOWEVER, BECAUSE TESTING IS PERFORMED IN ONLY A FEW LABORATORIES TO WHICH THE BLOOD SAMPLES ARE SENT, THERE IS AN UNAVOIDABLE DELAY IN OBTAINING RESULTS. THEREFORE, A STRIP TEST FOR QUICK ON-SITE DETERMINATION OF BLOOD GALACTOSE LEVELS WILL BE A VALUABLE TOOL FOR DETECTION OF GALACTOSEMIA AND FOR MONITORING ITS THERAPY. GDS TECHNOLOGY, INC., HAS RECENTLY DEVELOPED A STABLE AND SPECIFIC GALACTOSE DEHYDROGENASE THAT FORMS THE BASIS FOR THE STRIP TEST (SIMILAR TO MILES' OR BOEHRINGER'S GLUCOSE TEST). PHASE I IS A FEASIBILITY STUDY THAT WILL FOCUS ON THE DEVELOPMENT OF A VISUAL STRIP TEST BY INCORPORATING THE GALACTOSE DEHYDROGENASE AND AN INDICATOR SYSTEM THAT PRODUCES COLOR PROPORTIONATE TO THE SERUM CONCENTRATION OF GALACTOSE. THE GOAL OF PHASE II IS TO COMPLETE THE DEVELOPMENT OF A WHOLE-BLOOD STRIP TEST AND PERFORM CLINICAL TRIALS. THIS PROGRAM IS ATTRACTIVE AS THIS TEST FORMAT WILL IMPROVE PREVENTIVE MEDICAL CARE IN THE UNITED STATES AND COULD INCREASE TESTING IN UNDERDEVELOPED COUNTRIES.