To purchase three (3) 120 CNS kits to be measured on the Alamar Nulisa platform

Title: Purchase three (3) 120 CNS kits to be measured on the Alamar Nulisa platform which contains over 120 disease markers. (i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. (ii) The solicitation number is RFQ 75N95025Q04811V2 and the solicitation is issued as a Request For Quotation (RFQ). This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13'Simplified Acquisition Procedures; FAR Subpart 13.5'Simplified Procedures for Certain Commercial Items; and FAR Part 12'Acquisition of Commercial Items, and is not expected to exceed the simplified acquisition threshold. THIS IS A COMBINED SYNOPSIS SOLICITATION TO AWARD A CONTRACT OR PURCHASE ORDER ON A BRAND-NAME BASIS WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION. The National Institute on Drug Abuse (NIDA), Office of Acquisitions (OA), on behalf of the National Institute on Aging (NIA) intends to negotiate and award a Purchase Order for a Brand-Name product without providing for full and open competition. NULISAseq CNS Disease Panel 120 Kit (Catalog 800104) This acquisition is conducted as non-competitive for a commercial item or service and is conducted under the authority of the FAR Subpart 13.5'Simplified Procedures for Certain Commercial Items and 13.501 Special documentation requirements and the authority of 41 U.S.C. 1901. Pursuant to FAR Subpart 13.501 (a) (1) (iii) the justification (excluding brand name) will be made available within 14 days after contract award or in the case of unusual and compelling urgency within 30 days after contract award. Pursuant to FAR Subpart 13.501 (a) (1) (iv) the rationale for the brand name justification: The essential characteristics of the CNS Kits that limit the availability to a brand name are: - Ability to simultaneously profile 120 CNS proteins from 10 microliters of plasma or CSF. Some of the specific proteins included on the panel should be: AGRN, ARSA, BDNF, APOE,TDP43, NRGN, GFAP, pTAU217, pTAU231, pTAU181, S100B, TREM1, TREM 2, Oligo-SNCA, pSNCA-129, SNCA, MME, ICAM1, ENO2, and CNTN2 - Must be compatible with NULISA Technology and ARGO HT System. Only Brand-Name Alamar Biosciences NULISAseq CNS Disease Panel 120 kit (Catalog 800104) will satisfy this requirement, to the exclusion of other sources, because these kits are customized to run on the ARGO system and meet the salient characteristics necessary for the specific research. The material or service must be compatible in all aspects (form, fit, and function) with existing systems presently installed. The current equipment is the NULISA Technology and ARGO HT System, and the new item/service must coordinate, connect, or interface with the existing system. The ARGO Instrument is a fully automated, high-throughput precision proteomics platform for ultra- high sensitivity analysis across a range of multiplex levels to support broad biomarker profiling and translation of validated biomarkers. Reagent Kits and Software are proprietary to Alamar Bioscience, Inc. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2025-05, dated 08/07/2025. (iv) The associated NAICS code 334516 and the small business size standard 1,250 employees. This requirement is a brand-name only. (v) Brief Description: Three (3) Alamar NULISAseq CNS Disease Panel 120 Kits (Catalog Number: 800104) (vi) Generic Name: Kit for measuring 120 disease markers in EVs Statement of Need and Purpose: The National Institute on Aging (NIA), Laboratory of Clinical Investigation, investigates biomarkers of neurodegenerative diseases found in exosomes (vesicles 50-150nm in size) and isolates from patients plasma. NIA is able to isolate extracellular vesicles of different tissue origin. To validate, characterize and measure biomarkers, NIA needs to purchase three (3) 120 CNS kits to be measured on the Alamar Nulisa platform which contains over 120 disease markers. Background Information and Objective: Neurodegenerative diseases are diseases that greatly affect patients quality of life and they often require the need of caregivers. Lately these devastating diseases are increasing in affecting larger number of elderly individuals and presenting a greater burden on society and caregivers. Currently, adequate drugs that would cure the disease are nonexistent and treatment course of action mostly consists of mitigating the disease symptoms and improving patients quality of life. Diagnosis of neurodegenerative diseases is mostly possible at already advanced stages of disease, where symptoms are already quite pronounced and affect patients functioning. Disease detection at earlier stages and accurate predicting markers, could not cure the disease, but early preventive measures where combination of various treatments and lifestyle adjustments could potentially delay the disease onset and slow down progression of the disease. NIA's laboratory has pioneered the use of exosomal biomarkers which consist of various exosomal constituents, mostly proteins in exosomal cargo. To be able to discover novel biomarkers, characterize existing ones in a more advanced manner NIA must seek out novel and advanced technologies. The field of exosomal biomarkers is fairly new but is developing at a very fast pace, because of its tremendous potential in disease prognosis and diagnosis. In addition to biomarkers discovery, more in depth insight into mechanistic background is needed because the biomarkers are possibly involved in the intrinsic biological network that lies behind disease etiology. Given the importance of biomarkers and their existence in the nanoscale realm, Alamar - Nulisa platform is the only technology sensitive enough to satisfy this requirement, which is why the Alamar NULISAseq CNS Disease Panel 120 Kits are necessary. Salient characteristics: Ability to simultaneously profile 120 CNS proteins from 10 microliters of plasma or CSF. Some of the specific proteins included on the panel should be: AGRN, ARSA, BDNF, APOE,TDP43, NRGN, GFAP, pTAU217, pTAU231, pTAU181, S100B, TREM1, TREM 2, Oligo-SNCA, pSNCA-129, SNCA, MME, ICAM1, ENO2, and CNTN2 Must be compatible with NULISA Technology and ARGO HT System. (vii) Delivery Date: 120 days after receipt of purchase order. Shipping Address: National Institute on Aging BRC Building, ATTN: LCI 251 Bayview Blvd., Suite 100 Baltimore, Maryland 21224 (viii) The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items, applies to this acquisition. The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998), applies to this acquisition. This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at these addresses: https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html (End of provision) The following provisions apply to this acquisition and are incorporated by reference: FAR 52.204-7, System for Award Management (Oct 2018). FAR 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020). HHSAR 352.239-73, Electronic and Information Technology Accessibility Notice (December 18, 2015). The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998), applies to this acquisition. This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses: https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html (End of clause) The following clauses apply to this acquisition and are incorporated by reference: FAR 52.204-18, Commercial and Government Entity Code Maintenance (Aug 2020). FAR 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021). FAR clause 52.227-14, Rights in Data-General (May 2014). HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015). HHSAR 352.239-74, Electronic and Information Technology Accessibility (December 18, 2015). (ix) The provision at FAR clause 52.212-2, Evaluation - Commercial Items, applies to this acquisition. The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: It is NIA's intent to evaluate quotations received under the following factors using the details indicated below. Technical capability of the services offered to meet the Government requirement (Pass/Fail) Price Technical and past performance, when combined, are more important than price. Cost/price will be considered in the evaluation and selection, but cost/price will not be scored. (b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). (c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. (x) The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications'Commercial Items, with its offer. (xi) The FAR clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. Please be advised that the National Institute on Aging (NIA) is an Institute within the National Institutes of Health (NIH), which is a Federal agency. Your mass- market commercial and/or license agreement may include provisions that are customarily found in the commercial sector but which are not appropriate for a contract with a Federal agency. Specifically, NIA considers any provision in your mass-market commercial and/or license agreement to be inappropriate and unenforceable that: Contravenes a right granted NIA under U.S. copyright law (e.g., fair use, right to archive, copying for interlibrary loan), Violated the Federal Acquisition Regulation or other Federal law (e.g., Antideficiency Act, Principles of Federal Appropriations Law), Departs from reasonable consumer expectations and was not disclosed by the Licensor prior to agreement, or Violates fundamental public policy. NIA shall assume that you are in agreement with the statements herein if you submit a quotation. The following provisions and clauses apply to this acquisition and are incorporated as an attachment. Offerors MUST complete the provision at 52.204-24 and 52.204-26 pursuant to FAR 4.2103 Procedures and submit a completed copy as a separate document with their quotation. FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (NOV 2021) FAR 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (NOV 2021) FAR 52.204-26, Covered Telecommunications Equipment or Services-Representation (Oct 2020) NIH Invoice and Payment Provisions with IPP (Rev. March 2023) (xii) FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders'Commercial Items, applies to this acquisition. (xiii) The following additional contract requirement(s) or terms and conditions as determined by the contracting officer are necessary for this acquisition and consistent with customary commercial practices. None (xiv) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. (xv) Responses to this solicitation must include sufficient information to establish the interested parties bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description; and any other information or factors that may be considered in the award decision. Such factors may include: past performance; special features required for effective program performance; trade-in considerations; probable life of the item selected as compared with that of a comparable item; warranty considerations; maintenance availability; and environmental and energy efficiency considerations. Respondents that believe that they are manufacturers or authorized resellers of the brand-name product specified in this announcement must provide, as part of their response: (a) product, catalog, model, and/or part number(s); (b) product description; (c) all relevant information and documentation that the item(s) offered meets the salient physical, functional, or performance characteristics as specified in the purchase description; quantity; estimated price or cost; shipping, handling, and/or installation charges; and delivery date after receipt of order. In addition the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. All responses must be received by September 18, 2025 2:00pm Eastern Standard Time and reference number 75N95025Q04811V2. Responses may be submitted electronically to Christopher Belt at cbelt@nida.nih.gov. Fax responses will not be accepted.