Lateral flow array for undeclared food allergens
Ended Project Grant Awarded Last action
- Award ID
- R43FD007315
- Recipient
-
Akonni Biosystems Inc. UEI PGLAYC4UKDL7
- Awarding agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Obligated
- $504,261
Award facts
- Assistance listing
- 93.103 Food and Drug Administration Research
- Completion date
- Funding
-
- $336,174.00 Federal
- $168,087.00 Non-federal
- Funding agency
- Office of the Commissioner Food and Drug Administration, Department of Health and Human Services
- Place of performance
- Maryland, USA
Award details come from USAspending.gov.
Description
- Abstract
- At least 15 million americans and 5% of children under 5 years old suffer from food allergies. Many countries now have mandatory food labeling requirements for common allergens that are intentionally added to food products. Unfortunately, there are at least 170 known food allergens, and undeclared food allergens can accidentally contaminate a product through shared processing equipment, during transport, in storage, or because of fraud and terrorism, and result in adverse reactions or fatalities. The industry currently tests for undeclared food allergens with single-target elisas, high-resolution mass spectrometry, or related methods. Food processors and testing laboratories therefore continuously request and need a sensitive, specific, and easy-to-use multi-allergen test to minimize consumer health risk, and the potential for food recalls. The objective of this project is to fill this important public health technology GAP by incorporating biofront's proprietary monoclonal allergen antibodies within akonni's FDA-cleared DX2000 lateral flow microarray (LFA) platform, and validating system performance within the context of microbac's ISO 17025-compliant food safety testing service. In phase 1, we will verify the functionality and specificity of biofront monoclonal antibodies in akonni's lateral flow array; establish a test method that achieves a 1 PPM limit of detection for each of the target allergens; and demonstrate feasibility of the test with processed food extracts. These results will lay the foundation for a phase 2 project, where we will expand the test for all remaining high-priority allergens; transfer manufacturing and packaging to akonni's ISO13485-compliant production lines; use the platform to develop an aoac-approved analysis method at microbac; validate the system for microbac's top 10 foods/tests; and finish all other activities required to commercialize the system and testing/analysis service(S). Completing these milestones will establish a new class of multiplexed, component-resolved allergen detection products and food testing services that are expected to improve consumer/public safety, and provide producers an affordable mechanism to comply with zero-tolerance food safety policies.
Transactions
| Action | Federal | Non-federal | Date |
|---|---|---|---|
| Amendment | $0 | $0 | |
| Amendment | $0 | $0 | |
| Amendment | $0 | $0 | |
| Amendment | $0 | $0 | |
| Amendment | $168,087 | $0 | |
| Original award | $168,087 | $168,087 |
Quick answers
Who received award R43FD007315?
R43FD007315 was awarded to Akonni Biosystems Inc. by FDA Office of Acquisition and Grant Services (Food and Drug Administration) on September 20, 2021.
How much is award R43FD007315 worth?
$504,261 has been obligated on R43FD007315: $336,174 in federal funding and $168,087 in non-federal funding.
Which agency awarded R43FD007315?
FDA Office of Acquisition and Grant Services (Food and Drug Administration) awarded R43FD007315, with funding from Office of the Commissioner (Food and Drug Administration).
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