Hive 2.0: Expansion of FDA ARGOS

Title: Hive 2.0: Expansion of FDA ARGOS (database for Reference Grade micrObial Sequences)

Agency: U.S. Food and Drug Administration (FDA) Notice Type: Presolicitation: Cost Reimbursement

The U.S. Food and Drug Administration (FDA) intends to modify, on a sole source basis (in accordance with FAR 6.103-1), contract #75F40125C00095 with DNA HIVE, 3909 Fox Valley Drive, Rockville, MD 20853. The North American Industry Classification System (NAICS) code is 541714- Research and Development in Biotechnology (except Nanobiotechnology). The modification will not alter the existing period of performance established under the contract.

Under this sole source modification, the contractor shall provide research and development services (including, but not limited to, biological and bioinformatic research) to expand the current repository of genetic sequence information under the ARGOS database.

As such, this modification does not add new tasks, but rather expands on current tasks, specifically:

Aim-1: Deployment, configuration, launch ARGOS instance running on a newer version of H2O

Aim-2: Develop, adopt, and deploy AI and NGS Bioinformatics tools for:

Aim-2.1: evaluation of epigenetic based pathogen detection diagnostics products for Lyme disease.

Aim-2.2: assembly of new virus genomes for ARGOS using bulk public health sequencing datasets

Aim-2.3: evaluation of emerging pathogens.

Aim-2.4: predictive toxicology.

Aim-2.5: evaluation of food import safety.

Aim-2.6: on-, of-target evaluation of gene editing products.

Aim-2.7: evaluation of biologics manufacturing consistency.

Aim-2.8: evaluation of efficacy of attenuated vaccine and life viral products.

Aim-3: Deliver regulatory grade high-quality reference datasets.

Aim-3.1: Continuing to support FDA-ARGOS project with pathogen reference datasets.

Aim-3.2: Continuing to support epigenetic biomarker datasets for FDA.

Aim-4: Integrate FDA into ARPA-H FEAST network to provide RWD access.

Aim-5: Provide system installation, maintenance, user documentation and operation manuals and appropriate video materials for the entire system

This expansion is intended to increase the number of sequences and organisms that are validated in the ARGOS system, which will concurrently result in a marked increase in the utility of the ARGOS database, and enable interagency partners to have resources to support their individual research goals, including development of medical countermeasures to protect the American public.

Nature of the acquisition and proposed unique qualifications of the contractor(s).

DNA HIVE is currently under contract to conduct all of the tasks and deliverables envisioned under this acquisition, vis a vis performance of FDA contract, 75F40125C00095, was awarded in 2025 via the FDA Broad Agency Announcement (FDA BAA) program, following submission and review of their proposal under the BAA evaluation process. The concept, primary methodology, hypotheses, and anticipated outcomes constitute the intellectual property of DNA HIVE and the company's Principle Investigator (PI). By virtue of the research that is currently underway by this singular contractor, DNA HIVE is the only responsible source for the services at the level of quality required to feasibly meet the requirements of FDA and interagency partners. Furthermore, the scope of work does not entail commercial services, or off-the-shelf product delivery, but constitutes cutting-edge research that is dependent in large part on the expertise, project history, and research capabilities of the contractor.

The work done under the contract, and via the ARGOS program to date, has created an operational readiness and capability such that utilization of a different contractor would require extensive re-work (via the re-starting of sequencing, analysis, refinement, development and deployment of quality tools) in order to reach a readiness level to address the required work. This would (at minimum) introduce a lead-time of potentially 6 months to 1 year. Given that the target of this research entails infectious diseases and medical countermeasures, this gap directly leads to potential public health risks, especially given the current epidemiological environment (e.g., Hantavirus Outbreak in 2026 , Ebola Outbreak in 2026). The work envisioned will address response efforts for these outbreaks and will critically enhance preparedness for further disease risks to come. Consequently, use of another contractor will delay efforts significantly, and possibly indefinitely, generating a direct risk to the national capacity to identify and respond to public health emergencies.

Based on the above rationale, DNA HIVE is the only responsible source that will satisfy agency requirements.

This notice is not a request for competitive proposals. However, any party that believes it is capable of meeting the requirements as stated herein may submit a written response which clearly supports and demonstrates its ability to perform the requirements. Any response must be received by the response date and time set forth in this notice. Any response will undergo a review to determine whether the respondent can meet the contract requirements. A determination by the Government whether to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government.

Response Date and Time: 4:00 p.m. ET on July 2, 2026. Responses must be emailed to Kimberly Pennix at Kimberly.pennix@fda.hhs.gov, with a CC: to Nicholas Bisher at Nicholas.Bisher@fda.hhs.gov.