Vela Diagnostics Sequencing System for HIV-1 Genotype Testing

The Defense Health Agency Contracting Activity (DHACA) on behalf of the Diagnostics and Countermeasures Branch (DCB) at the Walter Reed Army Institute of Research (WRAIR) intends to award a Firm Fixed Price contract on a sole source basis to Vela Diagnostics, USA INC. The contract requires the provision of Sentosa sequencer kits, consumables, supplies, sequencing systems, and sub-components, as well as maintenance and repair. The system will be used for HIV genotype testing, which is critical for monitoring drug resistance mutations in HIV-1 infected soldiers and their beneficiaries. • The Sentosa NGS system includes instrumentation and reagents required to perform the Vela Sentosa SQ HIV-1 Genotype test in a College of American Pathologist (CAP) accredited laboratory. • The system and assay are Food and Drug Administration (FDA) approved, and clinical testing laboratories are required to use the instruments and reagents approved by the FDA in the execution of the test. • Market research was conducted, and it was found that similar products from other companies cannot meet or be modified to meet the Government's requirements. • The contract requires a reagent rental agreement between the manufacturer and the Government, which can only be met by Vela Diagnostics, USA INC.