Notice of Intent to Sole Source.pdf

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Nanostring Cassettes and Associated Reagents
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fRFQ-FDA-2021-1241715
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This notice of intent to sole source announces the Food and Drug Administration's requirement to procure Nanostring cassettes and associated reagents from Nanostring Technologies LLC through request for quote RFQ-FDA-2021-1241715. The cassettes provide the ability to simultaneously assay over 500 genes' expression for a single sample using twelve sample wells in each cassette, allowing multiple samples to be assessed at once. This proprietary technology from Nanostring Technologies provides a high-sensitivity, high-throughput technique to assess gene expression that would otherwise require significantly greater investment of time and money. The FDA currently owns a Nanostring analysis instrument and this requisition purchases the reagents to utilize it, requiring no additional equipment investment. Responses to demonstrate capability to meet this requirement are due by 12:00 p.m. EST on May 10, 2021 and should be emailed to Emmanuel Mbah. An award is anticipated to Nanostring Technologies within approximately fifteen days following this notice unless another source is found capable.

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Food and Drug Administration (FDA)

Notice of Intent to Sole Source

Subject: Fixed Price (FFP) Contract Type for the Procurement of Nanostring Cassettes and Associated Reagents -Sole Source to Nanostring Technologies LLC., under Request for Quote RFQ-

FDA-2021-1241715

Notice of Intent to Sole Source to: Nanostring Technologies LLC.

Pursuant to the authority of 41 USC 3304(a)(1), as implemented by Federal Acquisition Regulation (FAR) Subpart 6.302-1, (there is only one responsible source and no other supplies or services will satisfy agency requirements), the Food and Drug Administration (FDA) intends to award a Sole Source Fixed Price (FFP) Contract Type purchase order to Nanostring Technologies., located at:

Nanostring Technologies 530 Fairview Avenue North, Suite 2000 Seattle, WA 98109

(888) 358-6266 Contact: Ryan Vinton, Regional Account Manager rvinton@nanostring.com

FDA has a requirement to procure Nanostring Cassettes and Associated Reagents to Nanostring Technologies LLC., under Request for Quote RFQ-FDA-2021-1241715 as a sole source acquisition.

Nanostring cassettes provide the ability to assay over 500 genes’ expression simultaneously for a single sample. There are twelve sample wells in each cassette allowing multiple samples to be assessed at the same time. This technology provides a high sensitivity, high-throughput technique to assess gene expression that would otherwise require significantly greater investment of time and money to obtain the same information via more conventional assays.

The instrument and cassettes are proprietary technology only available through this vendor. No other vendor makes a comparable assay at the present time. In addition, FDA/CDER currently owns an analysis instrument (nCounter® MAX Analysis System) and this requisition purchases the reagents to use it. No equipment investment is required. Scientific literature was searched and new technologies available on the market were evaluated. No technologies were comparable and at a similar state of development (high sensitivity, high-throughput, well-validated) as the technology to be purchased.

Given that this instrument is proprietary in nature and that the manufacturer does not allow third party resellers, FDA will sole source this requirement to Nanostring Technologies Inc.

The associated NAICS Code is: 334516 - Analytical Laboratory Instrument Manufacturing.

Template mailto:rvinton@nanostring.com

This notice is not a request for competitive proposals. However, any party that believes it is capable of meeting this requirement as stated herein may submit a written capability statement that clearly supports and demonstrates their ability to perform the requirement. Capability statements must be received by the response date and time of this notice. Submissions will be reviewed to determine if they can meet the requirement. A determination by the Government to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government.

It is anticipated that an award will be issued to Agilent Technologies Inc, within approximately fifteen

(15) days after the date of this notice unless the Government determines that any other organization has the capacity to meet this requirement.

Response Date: 12:00 p.m. EST 05/10/2021. Please email responses to Emmanuel Mbah at Emmanuel.mbah@fda.hhs.gov mailto:Emmanuel.mbah@fda.hhs.gov

File details come from the government source that posted it. Updated .