Redacted DnF.pdf

Template last updated 4/23/2018

Brand Name

DETERMINATION & FINDINGS FOR OTHER THAN FULL & OPEN COMPETITION

(ACTIONS SAT AND BELOW)

1. DESCRIPTION OF PROPOSED PROCUREMENT: Qty One (1) Luminex® 200™ System

2. PROPOSED CONTRACTOR/MANUFACTURER: Luminex (Manufacturer). Sells only through the following resellers:

Life Technologies Corporation (Thermo Fisher) 3175 Staley Rd Grand Island, NY 14072

CAGE: 0JLD2

Large Business

Reseller

MilliporeSigma 400 Summit Dr Burlington, MA 01803

CAGE: 08071

Large Business Reseller

Government Scientific Source Inc 12355 Sunrise Valley Dr Reston, VA 20191

CAGE: 0S908

Small Business Reseller

Bio Techne 614 Mckinley Place NE Minneapolis, MN 55413-2610

CAGE: 9HQR6

Large Business Reseller

3. ESTIMATED TOTAL VALUE: $65,000.00

4. STATUTORY AUTHORITY PERMITTING CONTRACTING WITHOUT PROVIDING FOR FULL

AND OPEN COMPETITION: The statutory authority permitting sole source is 41 USC 1901(e), implemented by FAR 13.106-1(b)(1)(i):

_X_ Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

___ Unusual and Compelling Urgency ___ Industrial Mobilization; Engineering, Developmental, or Research Capability; or Expert

Services ___ International Agreement

___ Authorized or Required by Statute ___ National Security ___ Public Interest

5. JUSTIFICATION FOR THE AUTHORITY CITED ABOVE:

The item(s) listed in section one above is available from only one source and competition is precluded for reasons indicated below. There are no substitutes available.

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

___ Proprietary: A patent, copyright, or proprietary data limits competition. The proprietary data are described as follows:

_X Experimental Continuity: The item(s) must be consistent with prior materials in order to ensure experimental continuity. Describe the conditions that necessitate the use of experimental continuity:

The Biotechnology & Biological Sciences Division of the Army Research Laboratory (ARL) requires one (1) Luminex® 200™ System in support of ongoing research being conducted by the Biomaterials & Assembly Branch. This system is required to conduct experiments on specific, dyed magnetic beads for determining receptor affinities. Years of data have been collected in this manner, and it is necessary for the continuity of experimental results.

The system is a flow-based analyzer that enables high-throughput screening of numerous receptors for determining binding affinities to target analytes. It is used in the development of novel receptors for sensing/detection applications. Specifically, it utilizes dyed micron-sized polystyrene microspheres acting as both the identifier and the solid surface to build the assay; a flow cytometry-based instrument, integrating detection components, and software, which is designed for protocol-based data acquisition with robust data regression analysis. The system enables high-throughput binding assays to be conducted to assess as many as 80 different receptor samples in a given experiment in a 96-well plate format in less than an hour.

There is another instrument on the market, also manufactured by Luminex, it is the Intelliflex and is a more advanced and expensive model. This is the only other system capable of meeting the requirements mentioned above. However, since it is from the same manufacturer, the cheaper option is more advantageous for meeting the Government’s needs.

There are also, other flow-cytometers on the market. However, they lack the use of dyed, micron sized polystyrene beads for enabling receptor integration and screening. They lack the ability to screen as many as 80 different receptors (integrated on the beads) in single experiments in timeframes as little as one (1) hour.

By not awarding this requirement, the ability to screen and optimize large numbers of potential receptors will not be possible. Random guessing would be required to test an extremely limited scope of receptors by other means. Other testing means are significantly more expensive and significantly more time consuming (testing ~80 samples would result in in 20 times greater costs & increase screening time from 1-2 weeks to 2+ months if this were to be done with existing Surface Plasmon Resonance (SPR) capabilities. Otherwise, entirely new assays would need to be developed, proved and repeated and these would also result in significantly greater costs and time delays). It would prohibit development by restricting the amount of testing required to identify optimal binders. It would also negatively impact the amount of data acquired which can/is used to develop modeling and machine learning studies.

Previous experiments would need to be re-performed to directly compare binding results for use in receptor development, optimization and computational research efforts. This system has been used for over 12 years of ongoing research which would be extremely difficult to replicate in order to align previous, ongoing, and future studies. Ultimately, there would be significant time lost when conducting research, incomparable research results from previous & ongoing studies, and significantly increased costs arising from purchasing other materials, reagents and re-producing receptors to be compatible with new work flows.

Based off this market research it is in the Governments best interest to solicit this requirement as a brand name sole source for the Qty One (1) Luminex® 200™ System.

___ Warranty: Purchasing item(s) from another manufacturer/provider would void existing warranty. Provide a brief explanation for the use of this reason and the impact that would occur if the item was purchased from another manufacturer/provider:

___ Direct Replacement: These are “direct replacement” parts/components for existing equipment and no substitutes exist.

___ Other reasoning to support a sole-source buy:

6. FAIR AND REASONABLE PRICE DETERMINATION:

It has been determined that the anticipated cost to the Government will be fair and reasonable and that approval of this recommendation is in the best interest of the government. This justification is accurate and complete to the best of my knowledge and belief.

X Contracting Officer (KO)