Redacted Justification and Approval for Other Than Full and Open Competition Sequencing System for HIV-1 Genotype Testing

Background
The Defense Health Agency (DHA), specifically the Contracting Activity (DHACA) at the Research and Development, Contracting Division 1, is issuing a justification for a sole source contract for the Sequencing System for HIV-1 Testing. This contract is intended to support the HIV Diagnostics and Reference Lab (HDRL) at the Walter Reed Army Institute of Research (WRAIR). The contractor, Vela Diagnostics USA Inc., is the only manufacturer of the Vela SQ Sentosa Next Generation Sequencing (NGS) system currently utilized by DCB for HIV genotype testing, which is crucial for monitoring drug resistance mutations in HIV-1 infected personnel.

Work Details
The contractor shall provide all Sentosa sequencer kits, consumables, supplies, sequencing systems and sub-components, as well as maintenance and repair services. The specific requirements include:
- Sentosa SQ Next Generation Sequencing (NGS) system
- Instruments and reagents necessary to perform the Vela Sentosa SQ HIV-1 Genotype test in a CAP accredited laboratory.
- Maintenance to ensure compliance with CAP standards for clinical testing operations.
The total estimated value of the contract over its duration is $2,035,407.89.

Period of Performance
Base period from September 30, 2026 – September 29, 2027; with four option periods extending through September 29, 2031.

Place of Performance
Walter Reed Army Institute of Research (WRAIR), Fort Detrick, MD.

Bidder Requirements
Only Vela Diagnostics is authorized to supply the required products as they are FDA approved for clinical use. The manufacturer does not authorize third-party vendors to retail or support their products. Therefore, bidders must be direct suppliers from Vela Diagnostics to fulfill this requirement.