Development of a highly sensitive and specific POCT testing asthma triggering allergic IgE

Abstract The overall goal of this project is to develop and eventually commercialize a novel Point-Of-Care Test capable of rapidly and accurately detecting allergic IgE to environmental allergens in asthma patients as an approach promoting healthy living and reducing minority health disparities in response to RFA-23-003. The burden of asthma in the US falls disproportionately on Black, Hispanic and American Indian/Native Alaskans/Asians. These minority groups have the highest asthma rates, deaths and hospitalizations. IgE-mediated allergic asthma is the major type of asthma, consisting of ~70% of all the asthmas. The most relevant allergens triggering IgE- mediated allergic asthmas are environmental allergens that disproportionately impact the socioeconomically disadvantaged population and minorities due to their relatively constraint living conditions, lower available resources and limited access to healthcare, leading to the existing health disparities. Therefore, a more accurate, convenient, low-cost, rapid and point-of-care enabled IgE test capable of rapidly and accurately identifying allergic IgE by overcoming false positivity of the current IgE tests would be a key component in efforts to enhance healthy living and reduce minority health disparities, but such a point-of-care enabled IgE test is not currently available and yet to be developed. Under such background we propose to develop a novel IgE testing approach capable of rapidly and accurately detecting allergic IgE against the common allergens associated with allergic asthma triggering to address the health disparity issue, using Allerdia’s proprietary Reverse Lateral Flow ImmunoAssay (R-LFIA) technology platform. In Aim 1, we will Integrate the E. coIi expressed recombinant allergens into R-LFIA based IgE test to achieve higher detecting sensitivity and consistent test accuracy. In Aim 2, we will validate clinical sensitivity and specificity of the prototypic R-LFIA IgE test as a novel allergy diagnostic for rapid diagnosis of allergic asthmas in a prospective clinical study. Completion of the SBIR phase 2 Aims will pave the way for the US FDA regulatory approval via FDA’s newly established De Novo approval pathway for manufacture and commercialization of this novel IgE rapid test.