Multiplex Immunoassay Reader and Reagents 75N95025Q00262

(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 75N95025Q00262 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; and FAR Part 12 Acquisition of Commercial Items and is not expected to exceed the simplified acquisition threshold. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2025-05, with effective date August 7, 2025. . (iv) The associated NAICS code is 334516 and the small business size standard is 1,000. This requirement has a small business concern set-aside restriction. (v) This purchase requirement is to obtain: a Multiplex Immunoassay Reader and Reagents (please see attached purchase description) (vi.) This acquisition is necessary to provide brand name or equal instrumentation and reagents to the Laboratory of Neurogenetics for neurodegenerative disease research for multiplexed immunoassay capabilities, specifically blood glycoproteins. Biological sex influences risk for neurodegenerative diseases (NDDs), with Alzheimer s disease occurring more often in females and Parkinson s disease occurring more often in males. Here, we propose to investigate how hormonal fluctuations (associated with menopause and andropause) and sex chromosome dynamics shape both sex differences and within-sex variability in brain aging and NDD risk. We will generate new blood-based endocrine measures and integrate these data with existing intramural and published single-nucleus RNA sequencing (snRNA-seq) datasets from various brain regions to examine how menopause stage, sex hormone concentrations, and sex chromosome loss contribute brain aging in specific brain cell types. Specifically, we will measure: 1) blood steroid hormones using high-performance liquid chromatography-mass spectrometry (HPLC-MS/MS) performed by OpAns, LLC; and 2) blood glycoproteins (FSH and AMH) using Enzyme-Linked Immunosorbent Assays (ELISAs) and an associated plate reader from Mesoscale Diagnostics, LLC. By sampling males and females across the reproductive aging period including the menopause transition this work can illuminate how hormonal fluctuations due to reproductive aging contribute to changes in brain gene expression in ways that may impact susceptibility to NDDs. Our findings will enhance our understanding of how sex-related mechanisms and aging interact to influence brain health, potentially revealing novel therapeutic targets for NDDs. (vii) The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated delivery date of one month after receipt of completed purchase order. (viii) 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) FAR 52.211-6 Brand Name or Equal (Aug 1999) FAR 52.212-1 Instructions to Offerors--Commercial Items (SEP 2023) FAR 52.212-3 Offeror Representations and Certifications Commercial Items (SEP 2023) FAR 52.222-22 Previous Contracts and Compliance Reports (FEB 1999) 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. (End of clause) The following clauses apply to this acquisition and are incorporated by reference: FAR 52.204-13 System for Award Management Maintenance (OCT 2018) FAR 52.204-18 Commercial and Government Entity Code Maintenance (AUG 2020) FAR 52.212-4 Contract Terms and Conditions Commercial Items (DEC 2022). Addendum to this FAR clause applies to this acquisition and is attached. FAR 52.225-2 Buy American Certificate (Oct 2022) 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) The following provisions and clauses apply to this acquisition and are incorporated as an attachment. Offerors MUST complete the provisions at 52.204-24 and 52.204-26 and submit completed copies as separate documents with their proposal. FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (NOV 2021) FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation (OCT 2020) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (SEP 2023) NIH Invoicing Instructions With IPP (ix) The provision at FAR clause 52.212-2, Evaluation-Commercial Items, applies to this acquisition. Technical capability and past performance, when combined, are significantly more important than price. (a) 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: (i) technical capability of the service offered to meet the Government requirement; (ii) past performance [see FAR 13.106-2(b)(3)]; and (iii) price. (b) Options. N/A (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 (SEP 2023), with its offer. If the offeror has completed FAR clause 52.212-3 at www.sam.gov, then the offeror does not need to provide a completed copy with its offer. (xi.) 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. The vendor must be able to provide these specifications: Instrument must have multiplexing capabilities up to 10 assays per well Dynamic range of instrument must be greater than 105, with limits of detection as low as 005 1 pg/ml Due to laboratory space constraints, instrument must have a footprint equal to or lesser than 14 x24 x22 Must have plate stacking capabilities of up to 5 plates Detection must be measured via electrochemiluminescence and CCD camera (xii) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. (xiii) Responses to this solicitation must include sufficient information to establish the interested parties bona-fide capabilities of providing the product. 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. (xiiii) Respondents proposing on an equal product 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. The Unique Entity ID from SAM.gov, 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 quotations must be received by Tuesday, August 25, 2025, at 5:00pm Eastern Daylight/Standard Time and must reference solicitation number 75N95025Q00262. Responses must be submitted electronically to Tiffany Stone, Contract Specialist, at tiffany.stone@nih.gov. Fax responses will not be accepted.

NOTICE OF INTENT to Sole Source 1. SOLICITATION NUMBER: 75N95025Q00262 2. TITLE: Multiplex Immunoassay Reader and Reagents 3. CLASSIFICATION CODE: 6640 LABORATORY EQUIPMENT AND SUPPLIES NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing 4. RESPONSE DATE: September 25, 2024, at 9:00 PM EST 5. PRIMARY POINT OF CONTACT: Tiffany Stone tiffany.stone@nih.gov Phone: 301.480.7158 6. DESCRIPTION: INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institutes of Health (NIH) National Institute on Aging (NIA) intends to negotiate on a sole source basis with Meso Scale Diagnostics to provide the Meso Quickplex SQ 120mm Instrument, a Multiplex Immunoassay Reader and Reagent. The circumstances that limit the availability of this to one source are 1) the imagers are compatible only with microwell plates and immunoassay kits sold by Meso Scale Diagnostics, LLC; and 2) there are no other technologies that enable multiplexed measurement using electrochemiluminescence for detection. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS The intended procurement is classified under NAICS code 334516 - Analytical Laboratory Instrument Manufacturing with a Size Standard of 1,000 employees. REGULATORY AUTHORITY 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; and FAR Part 12 Acquisition of Commercial Items and is not expected to exceed the simplified acquisition threshold. The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2025-05 dated August 7, 2025. DESCRIPTION OF REQUIREMENT PURPOSE AND OBJECTIVES: The National Institutes of Health (NIH) is the nation s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people s health and save lives. The National Institiute on Aging (NIA) was established in 1974 to improve the health and well-being of older adults through research. NIA conducts and supports genetic, biological, clinical, behavioral, social, and economic research on aging and the challenges and needs of older adults. NIA is at the forefront of scientific discovery about the nature of healthy aging to extend the healthy, active years of life. The Laboratory of Neurogenetics for neurogenerative disease conduct research for multiplexed immunoassay capabilities, specifically blood glycoproteins. Biological sex influences risk for neurodegenerative diseases (NDDs), with Alzheimer s disease occurring more often in females and Parkinson s disease occurring more often in males. Here, we propose to investigate how hormonal fluctuations (associated with menopause and andropause) and sex chromosome dynamics shape both sex differences and within-sex variability in brain aging and NDD risk. We will generate new blood-based endocrine measures and integrate these data with existing intramural and published single-nucleus RNA sequencing (snRNA-seq) datasets from various brain regions to examine how menopause stage, sex hormone concentrations, and sex chromosome loss contribute brain aging in specific brain cell types. Specifically, we will measure: 1) blood steroid hormones using high-performance liquid chromatography-mass spectrometry (HPLC-MS/MS) performed by OpAns, LLC; and 2) blood glycoproteins (FSH and AMH) using Enzyme-Linked Immunosorbent Assays (ELISAs) and an associated plate reader from Mesoscale Diagnostics, LLC. By sampling males and females across the reproductive aging period including the menopause transition this work can illuminate how hormonal fluctuations due to reproductive aging contribute to changes in brain gene expression in ways that may impact susceptibility to NDDs. Our findings will enhance our understanding of how sex-related mechanisms and aging interact to influence brain health, potentially revealing novel therapeutic targets for NDDs. Contractor will ensure that the equipment meets the following specifications: Instrument must have multiplexing capabilities up to 10 assays per well Dynamic range of instrument must be greater than 105, with limits of detection as low as 005 1 pg/ml Due to laboratory space constraints, instrument must have a footprint equal to or lesser than 14 x24 x22 Must have plate stacking capabilities of up to 5 plates Detection must be measured via electrochemiluminescence and CCD camera ESTIMATED DELIVERY DATE: One month after receipt of completed purchase order. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted. Specifically, Meso Scale Diagnostics, LLC is the only sole proprietor of these systems. Only this suggested source can furnish the requirements, to the exclusion of other sources, because the laboratory analytical instruments required are manufactured and sold solely by Meso Scale Diagnostics, LLC and the imagers are compatible only with microwell plates and immunoassay kits sold by Meso Scale Diagnostics, LLC. The intended source is: Meso Scale Diagnostics, LLC 1601 Research Boulevard Rockville, MD 20850-3126 CLOSING STATEMENT THIS SYNOPSIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. However, interested parties may identify their interest and capability to respond to this notice. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Unique Entity ID (UEI), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. All responses must be received by the closing date and time of this announcement and must reference the solicitation number, 75N95025Q00262. Responses must be submitted electronically to Tiffany Stone, Contract Specialist, at tiffany.stone@nih.gov. U.S. Mail and fax responses will not be accepted.