Saphyr System Buyout

Closed Pre-Solicitation Posted

Solicitation number
NIH-CC-OPC-24-010165
Agency
NIH Clinical Center National Institutes of Health, Department of Health and Human Services
Responses due
Set-aside
No set-aside

Opportunity facts

NAICS code
334516 Analytical Laboratory Instrument Manufacturing
PSC
6632 Analysis Instruments, Medical Laboratory Use
Place of performance
Bethesda, Maryland 20892, United States
Points of contact

Notice details come from SAM.gov. Updated .

About this opportunity

Paragraph 1:

The National Institutes of Health (NIH) Clinical Center (CC) intends to award a firm-fixed price purchase order to Bionano Genomics Inc. for the buyout of a proprietary Saphyr System Bionano Optical Genome Mapping (OGM) instrument. The Saphyr System is used to detect structural chromosomal aberrations in patient bone marrow samples with hematological malignancies, cancer predisposing disorders, and other complex conditions. The acquisition will include the transfer of ownership, continuation of maintenance and support services, provision of software updates and upgrades, and comprehensive training for staff. This acquisition is being conducted using the Simplified Acquisition Procedures under FAR Part 13, as the total dollar value is not expected to exceed the Simplified Acquisition Threshold (SAT) of $250,000.

Paragraph 2:

This procurement is not set aside for any specific business type. Bionano Genomics Inc. is the sole-source provider of the Saphyr System and its associated supplies, which are proprietary. The acquisition will include the Bionano Prep SP-G2 BMA 12 Genome Bundle and G3.3 testing samples for patients. The period of performance for this contract is from August 1, 2024, to July 31, 2025.

Notice text

This is a Notice of Intent, not a request for a quotation. A solicitation document will not be issued, and quotations will not be requested.

The National Institute of Health, Clinical Center (CC) intends to award a firm-fixed priced purchase order to Bionano Genomics Inc., San Diego, California 92121-1989 on a sole source basis for the buyout of a proprietary Saphyr™ System Bionano Optical Genome Mapping (OGM) instrument. The period of performance will be 08/01/2024-07/31/2025.

This acquisition includes the Bionano Prep SP-G2 BMA 12 Genome Bundle, G3.3 testing samples for patients. The Bionano OGM instrument is currently operated under a reagent rental agreement with the vendor. The Saphyr™ System Bionano OGM instrument is utilized to detect structural chromosomal aberrations in patient bone marrow samples with hematologic malignancies, cancer predisposing disorders, and/or complicated clinical and pathological phenotypes that might not be detected by other molecular and sequencing techniques. This system is crucial for the accurate diagnosis and treatment planning for patients with these complex conditions. The acquisition will include:

-Transfer of ownership of the Saphyr™ System Bionano OGM instrument.

-Continuation of maintenance and support services as per existing agreements.

-Provision of any necessary software updates and upgrades.

-Comprehensive training for staff to ensure seamless transition and optimal utilization of the instrument.

Bionano Genomics Inc is the only vendor/manufacturer that can provide the instrument and supplies. The supplies are proprietary, there is only one supplier whose products can fit into the instrumentation; any other supply or service could cause the cancellation of the protocol or delays in completion of the protocol. The Saphyr™ System Bionano OGM instrument is patented, ensuring that no other company can legally produce or sell this specific technology.

This acquisition is being conducted using policies unique to the Federal Acquisition Regulation (FAR) Part 13 – Simplified Acquisition Procedures, Subpart 13.106-1(b)(1), For purchases not exceeding the simplified acquisition threshold (SAT), contracting officers may solicit from one source if the contracting officer determines that the circumstance of the contract action deem only one source reasonably available.  Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. The total dollar value of this requirement shall not exceed the Simplified Acquisition Threshold (SAT), $250,000.00.

Each response should include the following Business Information:

a. DUNS.

b. Company Name, address, POC, Phone and Email address

c. Current GSA Schedules or NAICS codes appropriate to this Award.

d. Type of Company (i.e., small business, 8(a), woman owned, hubZone, veteran owned, etc.) as validated in System For Award Management (SAM). All offerors must register on the SAM located at http://www.sam.gov/portal/SAM/#1

e. Comments to this announcement may be submitted to the Clinical Center, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Kimala Winfield, kimala.winfield@nih.gov by July 31, 2024, 9:00AM EST.

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