A04 SSJ Food Allergen Detection Assay Test Kit under SAT_Redacted.pdf

United States Department of Agriculture Sole Source (Including Brand Name) Justification under

Simplified Procedures for Certain Commercial Items FAR 13.106-1(b)(1) – Simplified Acquisitions

1. Identification of the agency and the contracting activity.

1a. Requesting Activity Agency:

USDA, FSIS, Office of Public Health Science (OPHS) Eastern lab 950 College Station Road Athens, GA 30605

1b. Contracting Activity:

USDA, FSIS, Office of Management (OM) Procurement Management Branch (PcMB) 5601 Sunnyside Avenue, Maildrop 5230 Beltsville, MD 20705-5230

2. Description of supply or service required to meet the agency’s needs.

The U.S. Department of Agriculture, Food Safety and Inspection Service (USDA FSIS) seeks to purchase kits that allows for the simultaneous analysis of the most common food allergens (crustacean, egg, milk, peanut, soy, gluten, almond, Brazil nut, cashew, hazelnut, macadamia, pine nut, pistachio, sesame and walnut) in ready-to-eat products for the routine allergens testing of denatured and non-denatured samples.

3. The rationale or circumstances for limiting competition.

Radix BioSolutions is the only vendor uniquely qualified of providing xMAP Food Allergen Detection Assay Kits for the routine testing of allergens on denatured and non-denatured samples. These kits are the only kits validated and approved in collaboration with the U.S. Food and Drug Administration (FDA) to align methodologies for the detection of the food allergens. They are also the only kits that allow for the rapid simultaneous testing of 15 food allergens (crustacean, egg, milk, peanut, soy, gluten, almond, Brazil nut, cashew, hazelnut, macadamia, pine nut, pistachio, sesame and walnut) in up to 48 samples in a single run, and are fully compatible with FSIS’s existing BioPlex instrumentation integrated into the laboratory’s routine allergen screening.

Radix BioSolutions is the only vendor that offers a validated, multiplexed allergen detection solution specifically designed for use on the xMAP platform already deployed at the USDA-FSIS Eastern Laboratory. Procuring additional kits from the same production lot ensures consistency in test results, avoids unnecessary variability, and upholds data integrity. Without these kits, the laboratory risks compromising sample throughput, delaying verification activities, and undermining public health protections.

Per the requirements in FAR 6.302-1(a)(2)(i)(A), Radix BioSolutions is the only responsible source, and no other supplies or services will satisfy agency requirements. Radix BioSolutions is the only source available that demonstrates a unique capability to provide the required supply, as it would otherwise be unavailable to the Government and does not resemble the substance of a pending competitive acquisition.

4. A description of the market research conducted and the results or a statement of the reason market research was not conducted.

Market research showed that although other vendors such as Neogen, Romer Labs, ELISA Systems, 3M, and Eurofins offer allergen test kits, none of their products meet the specific performance, throughput, or platform compatibility requirements of the FSIS program. These kits are generally single-analyte ELISA or lateral flow devices, which are incapable of multiplex detection and require extensive sample preparation. Implementing these alternatives would drastically reduce efficiency, increase cost, and require a full revalidation of the allergen detection method, thereby compromising the laboratory’s regulatory compliance and ISO 17025 accreditation.

The Radix BioSolutions xMAP Food Allergen Detection Assay Kits are the only kits validated for use in the USDA-FSIS Allergen Verification Program. These kits were developed through a scientific collaboration between USDA-FSIS and the U.S. Food and Drug Administration’s Center for Food Safety and Applied Nutrition (CFSAN). The collaboration focused on establishing a high-throughput method capable of simultaneously detecting 15 major food allergens in a single 96-well plate run using magnetic bead-based xMAP technology. The validated assay is fully compatible with FSIS’s existing BioPlex instrumentation and has been integrated into the laboratory’s routine allergen screening and confirmation workflows.

5. Estimated price, including all options, if applicable.

Base Period: $98,000.00

6. Recommended source(s).

Radix BioSolutions