precisionFDA cloud-based genomics platform

SPECIAL NOTICE — INTENT TO SOLE SOURCE Food and Drug Administration (FDA) Office of Acquisitions and Grants Services (OAGS)

Acquisition Title: FY26–FY30 precisionFDA Platform Indefinite Delivery Indefinite Quantity (IDIQ)

Acquisition Identification Number: ODT-2026-132021

NAICS Code: 541714

PSC Code: D319 (Cloud Computing)

Set-Aside: Small Business (DNAnexus confirmed SB under NAICS 541714)

Contract Type: Firm-Fixed-Price IDIQ

Period of Performance: 08/10/2026 – 08/09/2030

Estimated Value: $33,000,000

Notice:

The Food and Drug Administration (FDA), Office of Digital Transformation (ODT), Office of Data Analytics and Research (ODAR), Health Informatics Staff (HIS), intends to award a sole-source Indefinite Delivery Indefinite Quantity (IDIQ) contract to:

DNAnexus, Inc. 1975 West El Camino Real, Suite 204 Mountain View, CA 94040

This action is being conducted under the authority of FAR 6.302-1 (Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements), pursuant to 41 U.S.C. 3304(a)(1).

Description of Requirement:

The FDA requires continued operations, sustainment, modernization, and cloud support for the precisionFDA platform — a FISMA-authorized, secure, cloud-based collaborative research environment for next-generation sequencing (NGS) assay evaluation, genomics and multi-omics research, and regulatory science applications. The platform supports collaboration between FDA researchers and reviewers, as well as external collaborators and sponsors across multiple FDA centers, including CDER, CBER, CDRH, CVM, and CFSAN.

Services to be acquired include:

• Platform access licenses, cloud computing resources (compute, storage, data transfer on AWS), operations and maintenance, security patching, and technical support
• Continuation of all current precisionFDA capabilities, including immutable files with chain of provenance, file locking, Government-only spaces, Protected spaces, Review spaces, FHIR Stations, Scientific Challenge Framework, and custom data portal development capability
• Development and maintenance of the precisionFDA High (FISMA High) platform on FDA GovCloud
• FedRAMP Class C (Moderate) and FISMA High compliance maintenance per NIST SP 800-53 Rev5
• Integration support for FDA enterprise systems including the Global Substance Registration System (GSRS)
• Training, user support, disaster recovery, and business continuity services

Place of Performance: Contractor facility and FDA White Oak Campus, 10903 New Hampshire Avenue, Silver Spring, MD 20993

Basis for Sole Source Determination:

Comprehensive market research was conducted in accordance with FAR Part 10, evaluating 20 vendors with a detailed assessment of 8 shortlisted vendors against 33 critical capability requirements. The research conclusively determined that DNAnexus is the only vendor capable of meeting FDA's requirements for Day-1 continuity of the precisionFDA mission on the date of contract award, for the following reasons:

1. Only vendor with zero capability gaps: DNAnexus is the only vendor that scored fully across all 33 assessed capabilities. No alternative vendor can replicate on Day 1 the precisionFDA capabilities of immutable files with chain of provenance, file locking, Government-only spaces, Protected spaces, Review spaces, FHIR Stations, the Scientific Challenge Framework, or custom data portal development capability.

2. Unique secure external collaboration capability: DNAnexus is the only platform provider able to facilitate secure FDA-sponsored scientific challenges and controlled communication with industry sponsors, vendors, academic researchers, and international regulatory partners while maintaining regulatory-grade confidentiality controls, data segregation, audit trails, and compliance features.

3. Institutional knowledge and validated workflows: FDA has invested over seven years in developing, validating, and documenting bioinformatics workflows on the precisionFDA platform. Over 300 FDA scientific reviewers, bioinformaticians, and research scientists have been trained on the platform. The application library includes 100+ versioned apps. Migration to an alternative platform would require complete revalidation and an estimated $14.7M full rebuild.

4. FedRAMP and FISMA compliance: DNAnexus holds FedRAMP Class C (Moderate) authorization (Cert ID FR1814557199, confirmed June 18, 2026) and FISMA Moderate ATO (FDA-sponsored). DNAnexus is actively enrolled in the PRISM High-Impact Platform Pilot (March 2026) providing a structured pathway to FedRAMP High authorization, with a parallel FISMA High ATO track to support the precisionFDA High platform.

5. Small Business: DNAnexus is confirmed as a Small Business under NAICS 541714 (~277 employees; 1,000-employee size standard).

Response Instructions:

This notice is not a solicitation and does not commit the Government to award a contract. No award will be made solely on the basis of responses to this notice.

Interested parties who believe they are capable of meeting the Government's requirements in their entirety may submit a written capability statement to the Contracting Officer no later than 15 calendar days from the date of this notice. Capability statements will be evaluated to determine whether full and open competition should be conducted in lieu of a sole-source award.

Capability statements must address, at a minimum, the vendor's ability to provide Day-1 continuity of all current precisionFDA capabilities, FedRAMP Class C (Moderate) authorization status, and a demonstrated pathway to FISMA High authorization.

Responses must be submitted electronically to:

Steven Gagnon, Contracting Officer Email: Steven.Gagnon@fda.hhs.gov

Allison Meads, Contract Specialist Email: Allison.Meads@fda.hhs.gov

Subject Line: Capability Statement — precisionFDA IDIQ Sole Source Notice, ODT-2026-132021

Telephone responses will not be accepted. The Government is not responsible for any costs incurred in preparing a response to this notice.

Point of Contact:

Steven Gagnon, Contracting Officer Food and Drug Administration, Office of Acquisitions and Grants Services Email: Steven.Gagnon@fda.hhs.gov

Allison Meads, Contract Specialist Email: Allison.Meads@fda.hhs.gov