Hive 2.0: Expansion of FDA ARGOS
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The U.S. Food and Drug Administration (FDA) has issued a Presolicitation notice indicating its intent to modify, on a sole source basis, contract #75F40125C00095 with DNA HIVE for Hive 2.0: Expansion of FDA ARGOS. This effort will expand the Reference Grade micrObial Sequences (ARGOS) database. Interested parties capable of meeting the requirements may submit a written response by July 2, 2026, at 4:00 p.m. ET.
Scope of Work
This modification expands current tasks, focusing on research and development services, including biological and bioinformatic research, to enhance the ARGOS database. Key aims include:
- Aim-1: Deploying and launching an ARGOS instance on a newer H2O version.
- Aim-2: Developing and deploying AI and NGS Bioinformatics tools for:
- Evaluating epigenetic pathogen detection diagnostics (e.g., Lyme disease).
- Assembling new virus genomes for ARGOS using public health sequencing.
- Evaluating emerging pathogens, predictive toxicology, and food import safety.
- Assessing gene editing products and biologics manufacturing consistency.
- Evaluating attenuated vaccine and live viral product efficacy.
- Aim-3: Delivering regulatory-grade, high-quality reference datasets for pathogen and epigenetic biomarkers.
- Aim-4: Integrating FDA into the ARPA-H FEAST network for Real-World Data (RWD) access.
- Aim-5: Providing system installation, maintenance, user documentation, and operational manuals.
Contract & Timeline
- Type: Presolicitation (Sole Source Modification)
- Agency: U.S. Food and Drug Administration (FDA)
- NAICS: 541714 - Research and Development in Biotechnology (except Nanobiotechnology)
- Current Contractor: DNA HIVE
- Response Due: July 2, 2026, 4:00 p.m. ET
- Published: June 17, 2026
Justification for Sole Source
DNA HIVE is considered the only responsible source due to their existing contract, intellectual property ownership (concept, methodology, hypotheses, outcomes), and unique expertise in cutting-edge research. Utilizing a different contractor would necessitate extensive re-work, introducing a significant delay (6 months to 1 year) that could pose direct public health risks, especially concerning infectious diseases and medical countermeasures during ongoing outbreaks.
Response Information
This notice is not a request for competitive proposals. However, any party believing it can meet the stated requirements may submit a written response demonstrating its ability to perform. Responses will be reviewed to determine if the respondent can meet contract requirements. The government retains discretion on whether to compete this requirement.
Responses must be emailed to Kimberly Pennix (Kimberly.pennix@fda.hhs.gov) with a CC to Nicholas Bisher (Nicholas.Bisher@fda.hhs.gov).