Multiplex Immunoassay Reader and Reagents

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.