Justification- Luminex 200 redacted.pdf

Source Selection Information – See FAR 2.101 and 3.104

JUSTIFICATION FOR SOLE SOURCE (Simplified Acquisitions - MPT to <$250K)

Document number: ___1301177703_____________________

The supplies or services described herein are being solicited on a sole source basis and competition is precluded for reasons indicated below. There are no substitutes available for the supplies or services.

Check One:

☐ Service:

Contractor:

Contractor Address:

Contractor POC:

Phone #:

Email:

Cage Code/DUNS:

☒ Supply:

Restricted to the following source. If a sole source manufacturer distributes via dealers, ALSO provide dealer information.)

Original Manufacturer Name: Luminex Corporation Manufacturer: Thermofisher Manufacturer POC: Kate Seiser Manufacturer Phone #: 301-788-9180 Manufacturer Address: 3175 Staley Road

Grand Island, New York 14072 Dealer/Rep: Tommy Guy Dealer/Rep Address Phone No. 1-800-955-6288 Email: Tommy.guy@thermofisher.com

Description of the supplies or services required, the estimated price/cost, and required delivery date.

The Naval Submarine Medical Research Laboratory (NSMRL) requires the supply of a Luminex 200 Instrument System. The estimated cost is $63,000 with the computer, calibration kit, and performance verification kit included. This platform can run antibody and magnetic bead-based immunoassays for multiple protein target detection and quantitation. It can also measure RNA transcript concentrations for gene expression analysis. Typical analyzers can only assess one analyte at a time, but the Luminex 200 will allow for a wide screening in-house, which in the past has had to be outsourced to other laboratories. The Luminex 200 will provide NSMRL with the capability to conduct various biochemical analyses that will allow for the identification of physiologically relevant biomarkers which will be used to develop strategies to improve the health and performance of Navy Divers and Submariners in a time efficient manner. Specifically, it will facilitate measures that can indicate oxygen toxicity and decompression stress which will inform interventions to mitigate the risk in navy divers.

Specific features of Luminex systems include:

A fluidics system that allows for the interrogation of individual beads for both bead color (analyte) and the assay signal strength (PE fluorescence intensity) by flow cytometry.

Lasers for high-sensitivity detection. A 532 nm green laser to excite the assay PE dye and a 635 nm solid state red laser to excite the dyes inside the beads. The red laser also allows for doublet discrimination by light scatter.

Fluorescence-measuring detectors for each optical path.

Desktop PC with Windows 10 and xPONENT Software.

In conclusion, the requested supplies or services represent the minimum requirements of the government.

Describe in detail why only this source can furnish the requirements to the exclusion of other sources.

(what specific characteristics of the supplies or services limit the availability to a sole source (e.g., unique features, function of the item, etc.)?)

The Luminex LX 200 is a system that allows for multiplexing proteins and genes. It uses xMAP (Multi-Analyte Profiling) technology to measure up to 80 analytes at a time from a single sample, making it more efficient than a typical plate reader. It is the only brand that allows for this multiplexing to happen. This will keep prices down for analysis and save biochemical samples from multiple cycles of thawing for multiple assays. A typical plate reader does not allow for this multiplex analysis.

☒ A patent, copyright or proprietary data limits competition.

The Luminex LX 200 uses xMAP technology that cannot be utilized outside of their equipment.

Other information to support a sole source action:

Luminex (Diasorin)is the manufacturer of the instruments and does not sell or distribute the products. Listed resellers are distribution partners, Thermofisher Scientific (Life Technologies) and Fisher Scientific. Fisher Scientific is a Life Technologies entity. Contract Specialist conducted RFIs on both on NASA SEWP and GSA and it was concluded that an open market solicitation would allow for authorized distribution partners to quote.

Through market research it has been confirmed these distribution partners are able to meet delivery and installation to meet the minimum requirements of the government.

Document number: 1301177703

I CERTIFY THAT THE INFORMATION PROVIDED ABOVE IS COMPLETE AND ACCURATE 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 Date

Activity Title

I HEREBY DETERMINE THAT THE CIRCUMSTANCES OF THE CONTRACT ACTION DEEM ONLY ONE

SOURCE REASONABLY AVAILABLE IN ACCORDANCE WITH FAR 13.106-1(b)(1)(i).

Contracting Officer Signature Date

NAVSUP Fleet Logistics Center, Norfolk Contracting Department, Regional Directorate

Naval Submarine Medical Research Laboratory Research Physiologist

9.17.24