Basophil Activation Testing (BAT) for Allergy Diagnostics
Closed Pre-Solicitation Posted
- Solicitation number
- 05282025
- Agency
-
Defense Health Agency
Department of Defense
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541380 Testing Laboratories and Services
- PSC
- Q301 Reference Laboratory Testing
- Place of performance
- Bethesda, Maryland 20889, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Defense Health Agency's Walter Reed Medical Center is seeking a vendor to provide Basophil Activation Testing (BAT) services for allergy diagnostics using validated flow cytometry or equivalent methodologies. The contractor must operate from a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory and offer flexible BAT panel configurations, including both screening and comprehensive testing capabilities that can accommodate up to 10 allergen triggers covering food, environmental, drug, venom, and miscellaneous allergens per patient encounter. All testing methodologies must maintain FDA approval throughout the contract period, and the vendor must ensure HIPAA compliance with secure data exchange protocols. The agency requires support for both screening panels with 10-allergen configurations and confirmatory panels using graded concentrations. Companies with relevant capabilities and experience must submit their capabilities documents by June 30, 2025, with results expected within a clinically acceptable turnaround time of 5 business days.
This pre-solicitation notice does not include any set-aside designations, making it open to full and open competition among qualified vendors. No incumbent contractors or current service providers are identified in the opportunity documentation. The notice does not specify potential award values, budget ranges, or contract duration, focusing instead on the technical requirements and operational capabilities needed from prospective contractors. The key numerical requirements center on the flexibility to test up to 10 allergen triggers per patient encounter and the mandatory 5-business-day turnaround time for test results. The opportunity falls under NAICS code 541380 for Testing Laboratories and Services and PSC code Q301 for Reference Laboratory Testing, indicating the specialized nature of the diagnostic services required.
Notice text
Walter Reed Medical Center is looking for a vendor that can provide diagnostic Basophil Activation Testing (BAT) services using validated flow cytometry or equivalent methodologies. Testing must be performed in a Clinical Laboratory Improvement Amendments (CLIAC) certified laboratory, and the contractor shall offer a variety of BAT panel configurations including screening and comprehensive testing, with the flexibility to accommodate up to 10 allergen triggers for food, environmental, drug, venom, and miscellaneous allergens per patient encounter. All testing methodologies must be FDA-approved. If capability exists, results are expected to be provided within clinically acceptable turnaround time of 5 business days.
Requirements:
- Support both screening (10-allergen panels) and confirmatory (graded concentration) panels
- Maintain HIPAA compliance and secure data exchange
- Maintain CLIA certification and ensure all tests used are FDA-approved throughout the agreement period
If your company posseses this capability and has relevant experience, please provide this office with your capabilities document outlining your experience.
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