Premature infants (“preemies”), born with low birthweights, are at risk of an eye disease called retinopathy of prematurity– usually called “R-O-P”. To prevent ROP, we have invented the first A1C assay for preemies. An A1C assay is a blood test used to estimate glucose control. Preemies have trouble controlling glucose. The problem is that the standard A1C test cannot be used for preemies. We solved that! By modifying a commercial A1C assay, we created a prototype for preemie A1C. With our prototype, we conducted a study which has been published in the journal “Biomarkers”. We showed that high A1C in premature infants is linked with ROP. We also showed that A1C within days after birth predicts for the onset of ROP about 4 weeks later . This is exciting because this means that we can identify which babies need intervention before the onset of disease. With our technology, we can identify which of these preemies need an adjustment to their glucose to save their vision.
About 5% of premature infants, with low birthweights, develop the blinding form of ROP. Even after receiving treatment, 1000 U.S. children each year, become blind from ROP. The lifetime cost of blindness for just one child exceeds $2 million. Around the world, 50,000 infants go blind from ROP. Thus, ROP blindness causes a global burden of $100 billion. We are developing a product to prevent ROP. This will greatly improve the quality of life for premature children and their families.
What I Will Do With $5,000
Thus far, we modified a commercially available A1C test to create a prototype for measuring A1C in premature infants. Instead of a prototype, we need to develop a custom lab test for premature infants, that will ultimately receive FDA approval as a humanitarian medical device. To accomplish this, we need to purchase a variety of clinical grade antibodies. Then, we will test the antibodies to see which ones work best in our custom lab test. The cost of the antibodies will be about $5000.