75N98026Q00782_-_Pre-Solicitation_-_Immudex.docx
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- Solicitation number
- 75N98026Q00782
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This is a Sole Source Justification and Pre-Solicitation Notice for a custom reagent procurement by the National Cancer Institute (NCI). The National Institutes of Health Office of Logistics and Acquisition Operations is seeking Custom MHC Class II HLA-DP Xynapse and Dextramer Reagents for Liver Cancer Neoantigen Validation from Immudex USA, LLC/Immudex ApS under FAR 6.302-1 (Only One Responsible Source). The Government proposes to award on a sole source basis because Immudex exclusively owns the proprietary Dextramer technology and manufacturing capability, holding the intellectual property rights as the original developer. The contractor has demonstrated consistent performance with high-quality products, efficient production, and reliable delivery timelines in previous engagements with the Government.
The notice invites capability statements from any responsible source, including small businesses and women-owned small businesses, to demonstrate their ability to satisfy the requirement. Capability statements must be submitted via email to haunp@mail.nih.gov no later than 9:00 a.m. EDT on July 22, 2026. The Government anticipates making an award approximately five days after the closing date unless another source is determined capable of meeting the requirements. This is not a competitive procurement unless the Government receives and evaluates responses that demonstrate an alternative source's capability. Solicitation Number: 75N98026Q00782.
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(75N98026Q00782)
Sole Source Justification and Notice Authority FAR 6.302-1 – Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements Contracting Activity:
National Cancer Institute (NCI) Proposed Contractor:
Immudex USA, LLC / Immudex ApS Description of Requirement:
Custom MHC Class II HLA-DP Xynapse and Dextramer Reagents for Liver Cancer Neoantigen Validation Justification for Sole Source:
The National Cancer Institute (NCI) intends to negotiate on a sole source basis with Immudex USA, LLC/Immudex ApS pursuant to FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.
Immudex USA, LLC/Immudex ApS is uniquely qualified to provide the required custom MHC Class II HLA-DP Xynapse and Dextramer reagents because it possesses the proprietary technology, manufacturing capability, and specialized expertise necessary to produce these research reagents.
Custom Dextramers are available exclusively from Immudex ApS, the original developer and manufacturer of the Dextramer technology. Immudex holds the intellectual property and proprietary manufacturing process for the production of custom Dextramer reagents and is the sole provider of this service. Based on the Government's previous experience with Immudex products, the contractor has consistently demonstrated high-quality products, efficient production, and reliable delivery timelines that meet the requirements of ongoing research.
The Government is unaware of any other source capable of providing equivalent custom Dextramer reagents that satisfy the technical requirements of this acquisition. Accordingly, Immudex USA, LLC/Immudex ApS is considered the only responsible source capable of meeting the Government's requirements.
Small Business Notification:
This notice is not a request for competitive quotations. However, any responsible source, including small businesses, 8(a) firms, service-disabled veteran-owned small businesses, HUBZone small businesses, women-owned small businesses, veteran-owned small businesses, and small disadvantaged businesses, may submit a capability statement demonstrating their ability to satisfy the Government's requirement.
Capability statements will be evaluated solely to determine whether a competitive procurement should be conducted. A determination not to compete the proposed requirement based on responses to this notice is solely within the discretion of the Government.
Anticipated Award Date:
The Government anticipates making an award approximately five (5) days after the closing date of this notice unless the Government determines that another source is capable of satisfying the Government's requirement.
Capability statements shall be submitted via email to haunp@mail.nih.gov no later than 9:00 a.m. EDT on July 22, 2026.
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