In a continued effort to bolster national preparedness against emerging biological threats, the Biomedical Advanced Research and Development Authority (BARDA) has released the Phase 2 issue of the “Biothreat Diagnostic Rapid Response” Solicitation (RPP-25-06-DxR2) on May 29, 2025, under its Rapid Response Partnership Vehicle (RRPV). BARDA is seeking to address pressing gaps in diagnostic test readiness for high-priority biological threats. This opportunity is part of BARDA’s broader mission under the U.S. Department of Health and Human Services (HHS) to strengthen the nation’s public health emergency response infrastructure.
The RRPV is managed by Advanced Technology International (ATI) under an Other Transaction Agreement (OTA), which enables flexible and fast-track collaboration between the government, industry, and academia. With this solicitation, BARDA is targeting the rapid development and scalable manufacturing of diagnostic tests for select biothreat agents without relying on traditional stockpiling strategies. The overarching goal is to invest in “just-in-time” diagnostics that can be quickly deployed during a public health emergency.
Solicitation Overview: Building Resilient Biothreat Diagnostics
The DxR2 RPP is currently centered around the Base Period, the first of a potential three-phase program. During this phase, the awardees will develop, verify, and obtain FDA clearance for point-of-care or remote-use diagnostic tests covering six key PHEMCE-prioritized biothreats: glanders, botulism toxin (BoNT), tularemia, typhus, smallpox, and plague. Awardees will also be expected to complete limited manufacturing runs, quality and stability testing, early adopter training, and a comprehensive manufacturing capacity study to assess the feasibility of rapid response capabilities.
To be considered competitive, demonstrate CLIA-waived or waivable, that deliver results in under 30 minutes, and can operate in non-clinical or austere environments. Preferred attributes include a small and low-weight form factor that has battery or solar power options, and connectivity for secure data transmission.
While Option I (Warm-base Surge Capacity) and Option II (Manufacturing Line Modifications) are envisioned as future phases, BARDA is currently not requesting for proposals for those phases at this time. However, offerors should be aware that BARDA may expand project scope based on the success of the Base Period and availability of additional funding.
Key Dates and Milestones
BARDA has outlined a clear timeline for interested offerors to engage with this opportunity:
- May 29, 2025 – RPP released
- June 5, 2025 – Proposers Conference (virtual)
- June 12, 2025 – Deadline to submit questions
- June 19, 2025 – Answers to submitted questions released
- July 14, 2025 (1:00 PM ET) – Final proposals due
Note: Offerors must be RRPV Consortium Members to be eligible to apply. Membership instructions can be found at www.rrpv.org/how-to-join.
Funding Details and Award Structure
BARDA anticipates awarding approximately $40 million for the Base Period, with up to 4 awards expected. The anticipated period of performance is 36 months, beginning around October 2025 (subject to negotiation).
Cost-sharing is strongly encouraged to maximize public-private collaboration, but it is not a requirement. The OTA mechanism provides flexibility in contract structuring and intellectual property negotiations, governed under the RRPV Base Agreement.
Strengthening Health Security Through Scalable Diagnostics
This RPP exemplifies BARDA’s commitment to shifting from stockpiling to sustainable, surge-ready manufacturing of diagnostic tools for national security. The tests developed through this program will help the U.S. respond faster to deliberate or naturally occurring biothreat events..
If your organization has diagnostic capabilities aligned with BARDA’s mission and is ready to support national health security, this is a timely and high-impact opportunity to pursue.
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