AN ON-SITE STRIP TEST FOR SCREENING OF GALACTOSEMIA

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: N/A
Agency Tracking Number: 13808
Amount: $50,000.00
Phase: Phase I
Program: SBIR
Awards Year: 1990
Solicitation Year: N/A
Solicitation Topic Code: N/A
Solicitation Number: N/A
Small Business Information
25235 Leer Dr, Elkhart, IN, 46514
DUNS: N/A
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 Aurora F De Castro
 (219) 264-7384
Business Contact
Phone: () -
Research Institution
N/A
Abstract
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.

* Information listed above is at the time of submission. *

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