BioFire_FilmArray_SSJ_Redacted.pdf

NAVSUPINST 4200.85D, Encl (1) 1 of 2

JUSTIFICATION FOR SOLE SOURCE (Simplified Acquisitions <$150K)

The service or material listed on is sole source and competition is precluded for reasons indicated below. There are no substitutes available for this material or service.

Restricted to the following source. Provide original manufacturer’s name. (If a sole source manufacturer distributes via dealers, ALSO provide dealer information.)

Manufacturer: BioFire, A BioMerieux Company

Manufacturer POC & phone nr. 801-736-6354 x 1502 / salesorders@biofiredx.com

Mfr. Address: 515 Colorow Drive Salt Lake City, Utah 84108 USA

Dealer / Rep: Same as above

Dealer / Rep address / phone nr. Same as above

__X__ Description of the item or service required, the estimated cost, and required delivery date.

This requirement is for the procurement of one BioFire FilmArray 2.0 System. The system will be utilized at the Multinational Force and Observers camp in south Saini in support of the Naval Medical Research Unit No. 3’s (NAMRU-3) studies on infectious diseases. The estimated cost is , and the required delivery date is as soon as possible.

__X__ Specific characteristics of the material or service that limit the availability to a sole source (unique features, function of the item, etc.). Describe in detail why only this suggested source can furnish the requirements to the exclusion of other sources.

BioFire is the industry leader in infectious disease diagnostics; and, provides molecular solutions that lessen the time to medical results, empower healthcare professionals to make better diagnostic decisions, and lower healthcare costs.

BioFire is the sole manufacturer of the FilmArray 2.0; an intricately designed streamlined system with many applications. FilmArray 2.0 is a FDA-cleared multiplex PCR system that integrates sample preparation, amplification, detection and analysis. The system has four FDA-cleared panels – the Respiratory Panel, the Blood Culture Identification Panel, the Gastrointestinal Panel, and the Meningitis/Encephalitis Panel; and, together these panels cover the vast majority of pathogens of military relevance.

The FilmArray 2.0 systems single database management and LIS-interfacing capabilities enable simplified test ordering and send outs, quicker turnaround times, and increased accuracy by minimizing manual data entry.

The BioFire FilmArray 2.0 System is proprietary in nature. Only BioFire technical support personnel are familiar with the systems configurations, and are the only trained individuals capable of providing the appropriate training and support to the customer.

Additionally, BioFire does not allow third party access. Only BioFire personnel possess the intricate knowledge, hands on experience, appropriate education and technical skills specifically developed to provide the customer with superior training and support.

___ The requested material or service represents the minimum requirements of the government.

CHECK & FILL IN ALL APPLICABLE BLANKS BELOW

__X__ The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. Describe the equipment/function you have now and how the new item/service must coordinate, connect, or interface with the existing system.

courtney.golden Sticky Note

NAVSUPINST 4200.85D, Encl (1) 2 of 2

Currently, NAMRU-3 has three pieces of FilmArray 2.0 System. The first is located in Camp Lemonier, Djibouti, the second is located at the US embassy in Egypt, and the third is located at the Jordanian Royal Medical Services.

The new BioFire FilmArray 2.0 System will be located and utilized at the Multinational Force & Observers camp in south Saini in support of NAMRU-3 studies on infectious diseases in the AOR. Together the four pieces of equipment will provide valuable information regarding etiologies causing infectious diseases in different locations of the region.

Furthermore, the FilmArray 2.0 System is exclusive to BioFire. If awarded to another manufacturer, NAMRU-3 would be forced to change the platform for the designed assays; ultimately, requiring reconfiguration of all the assays, wasting time and resources, and potentially jeopardizing our ability to provide timely results to our collaborators/funders. This would result in a duplication of efforts and egregious cost.

__X__ A patent, copyright or proprietary data limits competition. The proprietary data is

____ These are “direct replacements” parts/components for existing equipment.

__X__ Other information to support a sole source buy:

Any proposed equipment acquisition on behalf of the U.S. Navy requires extensive product testing by each expert performing member. A great deal of research has resulted in the determination that only the BioFire system will meet NAMRU-3’s requirement.

I CERTIFY THAT STATEMENTS CHECKED, AND INFORMATION PROVIDED ABOVE, ARE COMPLETE

AND CORRECT TO THE BEST OF MY KNOWLEDGE. I UNDERSTAND THAT THE PROCESSING OF

THIS SOLE SOURCE JUSTIFICATION PRECLUDES THE USE OF FULL AND OPEN COMPETITION.

Signature Title ____________________________

Activity ______________________________ Date ____________________________

Contracting Officer Signature _________________________________________

Date ________________________________ SAP Sole Source