SBIR Phase I: Real-Time Allergen Detection Technology for Dietary Proteins Transferred to Human Milk

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to provide the first test to determine the allergen content of human milk accurately, quickly, and cost-effectively. As much as 25% of infants have reported allergic responses to dietary proteins found in human milk which often results in breast/body feeding termination. Breast/body feeding is incredibly beneficial to health and continuation of nursing is a human health issue. Studies indicate that human milk is superior to hypoallergenic formula, providing natural antibodies to fight illness, lowering the risk of sudden infant death syndrome, and reducing the probability of developing disorders such as diabetes and leukemia. There is currently no at-home, real-time test for milk allergens on the market. This Small Business Innovation Research (SBIR) Phase I project seeks to develop a real-time at-home allergen detection test. This project lays the groundwork for providing the first mechanism to research early and often allergen introduction through human milk when the immune system has been shown to be susceptible to allergy reduction strategies. The company’s patent-pending technology has the potential to provide a tool to identify allergens quickly and cost-effectively, allowing parents to monitor the presence of likely allergen triggers. The test is performed by the user in a real-time, in an at-home setting, which is a significant advantage over existing tests that require samples to be sent to a laboratory for labor and resource-intensive assays. The lateral flow technology provides a rapid and easy-to-read result, allowing the user to quickly determine whether the milk contains specific non-human protein fragments which are also known to elicit allergic responses in some patients. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.