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

Award Number: R44HL167289
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/01/2023
PERIOD OF PERFORMANCE END DATE: 06/30/2026

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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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $921,539 )
2025	2025	ALLERDIA INC	2010 MALCOLM AVE	LOS ANGELES	CA	90025	LOS ANGELES	USA	Lung Diseases Research	000	3	7/24/2025	NON-COMPETING CONTINUATION	$921,539
														Subtotal = $921,539

Issue Date FY: 2024 ( Subtotal = $1,109,675 )
2024	2024	ALLERDIA INC	2010 MALCOLM AVE	LOS ANGELES	CA	90025	LOS ANGELES	USA	Lung Diseases Research	000	2	7/10/2024	COMPETING CONTINUATION	$1,109,675
														Subtotal = $1,109,675

Grand Total All Awards = $2,031,214

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

Award Number: R44HL167289

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 02/01/2023

PERIOD OF PERFORMANCE END DATE: 06/30/2026

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