THERAKOS CELLEX Photopheresis System Procedural Kits
Closed Pre-Solicitation Posted
- Solicitation number
- 25-007707
- 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
- 325413 In-Vitro Diagnostic Substance Manufacturing
- Place of performance
- Maryland 20892, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The National Institutes of Health Clinical Center's Department of Transfusion Medicine intends to procure five cases of THERAKOS CELLEX Photopheresis System Procedural Kits for emergent Extracorporeal Photopheresis procedures used in patient care. These specialized medical kits are used to draw patient blood, separate white blood cells through centrifugation, and expose them to ultraviolet light to induce programmed cell death as part of rare photopheresis treatments. The agency plans to award this as a sole source, firm-fixed price contract to Therakos Inc., located in Hazelwood, Missouri, as they are the exclusive manufacturer of this proprietary equipment and the only vendor approved by the Quality Assurance Team. The procurement is being conducted under FAR Part 13 Simplified Acquisition Procedures, which allows for single-source solicitation when only one source is reasonably available. Interested parties capable of providing similar products may submit capability statements by the July 5, 2025 deadline, though the government retains sole discretion in determining whether to conduct competitive procurement.
This opportunity carries no set-aside designation and is intended for Therakos Inc. as the incumbent contractor and sole source provider. The procurement involves exactly five cases of Cellex USA Kits (catalog number CLXUSA), with the agency noting that large quantities are not typically stocked due to high costs, short expiration dates, and unpredictable patient treatment needs. The urgency for this procurement stems from a recent recall of existing kits that significantly reduced inventory levels, necessitating immediate replacement while awaiting manufacturer resolution of the recalled items. The acquisition falls under NAICS code 325413 for In Vitro Diagnostic Substance Manufacturing with a small business size standard of 1,250 average employees, and the place of performance is designated as Bethesda, Maryland. While specific contract values are not disclosed, the agency emphasizes the astronomical costs associated with these specialized medical kits and the critical nature of maintaining adequate inventory for emergency patient care situations.
Notice text
THERAKOS CELLEX Photopheresis System Procedural Kits
Product Service Code: 6650- Optical Instruments, Test Equipment, Components and Accessories
NAICS Code: 325413: In Vitro Diagnostic Substance Manufacturing small business 1,250 average number of employees.
Place of Performance: Bethesda, MD 20892
POTS: 25-007707
Description:
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 Institutes of Health, Office of Purchasing and Contracts on behalf of Department of Transfusion Medicine (DTM) intends to award a firm-fixed price contract to Therakos for quantity five (5) cases of Cellex USA Kits needed for emergent Extracorporeal Photopheresis kits used for patient care on a sole source basis located at Therakos Inc. 675 James S Mcdonnell Blvd Hazelwood, Missouri 63042 to procure this kit.
LINE # List of Equipment: Catalog # Qty
01 Cellex USA Kits CLXUSA 5.00
Cellex USA Kits are needed for Extracorporeal Photopheresis (ECP) procedures for Clinical Center patients. These kits are only manufactured and sold by the Cellex equipment manufacturer Therakos. These kits are for very rare photopheresis procedures that are not done regularly. The request for these procedures is based on treatment plans that vary based on the condition of the patient(s) and are communicated to the primary care team as needed. It is used for to draw patient’s blood, and the white blood cells (including T cells) are separated from the rest of the blood using centrifugation, and the separated white blood cells are then exposed to Ultraviolent (UVA) light, which damages the DNA of the treated cells, rendering them apoptotic (programmed cell death). There are no stock large quantities due to the high costs, short expiration date, and the unpredictability of the need. In addition, due to the astronomical costs, it would not be ideal to stock them and have them expire. However, this recently had a recall of some kits which have significantly lowered inventory. While waiting for replacement of the recalled kits by the manufacturer it is important to order more kits now since it takes a while for the orders to go through procurement. Therakos Inc. is the sole manufacture of its equipment and proprietary software and the only approved vendor by the Quality Assurance Team to perform this procurement.
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.
Interested Parties: Interested parties capable of providing the same or similar products or services described in this notice may submit a capability statement outlining their capability to perform the described work. Capability Statements must be received within the time set forth in this synopsis to be considered by the Government. The determination to compete this proposed contract based on responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.
Comments: Comments to this announcement, referencing this posting number, may be submitted to the CC, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Emeka Onyejekwe, Contract Specialist, Emeka.onyejekwe@nih.gov by the due date July 05th, 2025, and time marked in this notice.
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