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Aptamer-enabled multiplex electrochemical sensor for robust and efficient assessment of flu vaccine potency

Award Number: R43AI142977
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/01/2019
PERIOD OF PERFORMANCE END DATE: 12/31/2020

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Aptamer-enabled multiplex electrochemical sensor for robust and efficient assessment of flu vaccine potency - Every year, nearly 100 million people in the US receive flu vaccines, accounting for a $2 billion market. Due to antigenic drift, new flu vaccines need to be produced every year under an extremely tight timeline. Delays in manufacturing have severe healthcare consequences. A major rate-limiting step in the flu vaccine manufacturing process is the assessment of vaccine potency. The single radial immunodiffusion (SRD) assay is the current gold standard method, but suffers from several limitations: 1) the SRD reagents need to be freshly prepared every year by immunizing sheep, which takes multiple months and presents a bottleneck when the vaccine is most needed. 2) SRD is labor-intensive and requires trained personnel, and takes several days to complete; 3) SRD was originally validated against inactivated vaccine; growing evidence suggests it may not be suitable for novel vaccines. In result, both recent EMA guidelines and a joint workshop by FDA and WHO concluded that alternative methods should be developed to address these limitations, and that an ideal assay should be “low cost, not labor-intensive, high throughput, high specificity, stability-indicating, and indicative of antigenic structure and vaccine efficacy”. We propose to solve this problem by developing an aptamer-based multiplex electrochemical biosensor. Similar to SRD, our sensor is low-cost, highly specific, and can assess vaccine stability and efficacy. It also has two key advantages that make it an ideal assay for flu vaccine potency. 1) It uses aptamers (nucleic acid ligands) to overcome the limitation of antibodies. Because aptamers are developed in vitro, we can create a highly robust and rapid process that yields new strain-specific aptamers in 4 weeks. Aptamers are more stable and consistent than antibodies, and have a well-defined composition, and thus support standardization and broad dissemination within the R&D community. 2) The device utilizes a microfluidic multiplex electrochemical sensor design which enables rapid and accurate assays, minimal hands-on time, and ease of manufacture. If successful, our product has the potential to provide life-saving benefits by overcoming a critical risk in flu vaccine production. !


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: 2021 ( Subtotal = $0 )
2021	2019	APTITUDE MEDICAL SYSTEMS, INC.	125 CREMONA DR # 100	GOLETA	CA	93117	SANTA BARBARA	USA	Allergy and Infectious Diseases Research	000	1	6/28/2021	NEW	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2019	APTITUDE MEDICAL SYSTEMS, INC.	2219 BATH ST	SANTA BARBARA	CA	93105	SANTA BARBARA	USA	Allergy and Infectious Diseases Research	000	1	2/21/2020	NEW	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $222,999 )
2019	2019	APTITUDE MEDICAL SYSTEMS, INC.	2219 BATH ST	SANTA BARBARA	CA	93105	SANTA BARBARA	USA	Allergy and Infectious Diseases Research	000	1	3/14/2019	NEW	$222,999
														Subtotal = $222,999

Grand Total All Awards = $222,999

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Aptamer-enabled multiplex electrochemical sensor for robust and efficient assessment of flu vaccine potency

Award Number: R43AI142977

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 04/01/2019

PERIOD OF PERFORMANCE END DATE: 12/31/2020

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