FBO_J A_Redacted.pdf

Single Source Justification (Simplified Acquisition)

SAF/AQCP Template | 1 May 2014 Page 1 of 2

Section A: General Contract Information

Contracting Activity: 10 CONS/LGCB Purchase Request/ Identification Number:

Project/Program Name: Film Array Estimated Contract Cost (including Options):

Section B: Description of the Supplies/Services Required

Requirement is for the acquisition of eight(8) BioFire FilmArray 2.0 analyzers (product code FLM2-ASY-001). The FilmArray is a user-friendly multiplex polymerase chain reaction (multiplex PCR) which is a modification of polymerase chain reaction in order to rapidly detect deletions or duplications in a large gene. This process amplifies gnomic DNA samples using multiple primers and a temperature-mediated DNA polymerase in a thermal cycler. The FilmArray integrates sample preparation, amplification, detection and analysis all into one complete process that delivers results in about an hour.

Section C: Justification for Soliciting from a Single Source

The BioFire FilmArray 2.0 is the only FDA cleared commercially available self-contained multiplex PCR analyzer available with four (4) FDA cleared panels which tests for human pathogens that have the potential to impact military readiness. The 4 panels offered by BioFire analyze human specimens for the presence of respiratory pathogens, gastrointestinal pathogens, septicemia pathogens and meningitis/encephalitis pathogens. BioFire also has an Ebola Zaire assay available through emergency use only terms, and a biological threat panel capable of detecting biological agents of military importance. The design of the assay pouches allows for minimal operator exposure to samples and minimal training required, while allowing for the multiplex PCR analysis for multiple pathogens at the same time. The reagent pouches are self-contained, and combine specimen preparation, extraction, amplification, detection, and analysis in one easy step, and results are available in approximately 1 hour.

Section D: Efforts to Obtain Competition

A sources sought was posted to FedBizOps on 29 February with a closing date of 4 Mar 2016. The posting received 2 additional responses both from the BioFire Defense affiliate of BioFire. However, after their initial response the respondents subsequently clarified that they had miss interpreted the request as an applied technology requirement versus a Diagnostics requirement and indicated they could not supply the needed equipment. In-house demonstrations and internet searches were also utilized and found other vendors that offer some of the platforms with capabilities similar to the BioFire FilmArray 2.0. Other platforms/panels that were evaluated with in-house vendor demonstration included the Luminex xTAG respiratory panel and GI panel, the GenMark Dx eSensor respiratory viral panel, and the Verigene RP Flex test, which offers a respiratory pathogen testing menu similar to the FilmArray.

None of the other surveyed platforms offer all four of the panels that the BioFire FilmArray platform offers nor do they offer either the Ebola Zaire assay or the biological threat panel.

Section E: Steps to Preclude Future Single Source Awards

This is a one-time buy which involves the need for a product that is only available from one source. There are no plans at this time to compete future contracts for the type of supply covered by this document. If another potential source emerges, it will be assessed to determine whether competition for future requirements is feasible.

Single Source Justification (Simplified Acquisition)

SAF/AQCP Template | 1 May 2014 Page 2 of 2

Section F: Contracting Officer's Determination

I have determined, in accordance with FAR 13.106-1(b)(1), that the circumstances of this contract action deem only a single source is reasonably available.

Date Typed Name and Rank/Grade of Contracting Officer Signature of Contracting Officer