SIMOA HD-X Analyzer Maintenance

PRE-SOLICITATION NOTICE OF INTENT NON-COMPETITIVE INTRODUCTION PURSUANT TO FAR Subpart 5.2—Synopses of Proposed Contract Actions, THIS IS A PRE-SOLICITATION NOTICE OF A PROPOSED CONTRACT TO ACTION. THIS IS A PRE-SOLICITATION NON-COMPETITIVE NOTICE OF INTENT TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institute on Drug Abuse (NIDA), Office of Acquisition (OA) at the National Insitutes of Health (NIH) on behalf of the National Institute of Neurological Disorders and Stroke (NINDS) intends to negotiate and award a purchase order for a service maintenance package for a SIMOA HD-X Analyzer to the only authorized service provider, Quanterix Corporation, 900 Middlesex Turnpike, Billerica, MA 01821. The SIMOA HD-X Analyzer is a highly sensitive and specialized equipment and only Quanterix is an authorized service provider.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 811219 with a Size Standard of $22M.

REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses of the Federal acquisition Requlation (FAR) currently in effect at https://www.acquisition.gov/ STATUTORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source.

DESCRIPTION OF REQUIREMENT Project Description Complete basic service and warranty package for one SIMOA HD-X Analyzer. Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the work below:

• Unlimited technical support, including email and telephone responsiveness within 2-3 working days. • Unlimited on-site repair by Quanterix certified engineer, including parts labor and travel at no additional cost. • 2 preventative maintenance visits per year, which includes replacement of parts as needed and not to be concluded until a “SIMOA qualification test” (SQT, a Quanterix internal machine function test) has “passed”. • Software updates and firmware fixes for critical issues Purpose and Objectives The HD-X instrument that performs SIMOA assays is a unique and highly sensitive instrument containing complex fluidics and specialized light measuring components.

It is vital for this instrument to be under constant care by a Quanterix-certified filed engineer to keep the instrument in good working order. Lapse of service coverage for >30 days would incur costs associated with an additional service visit to verify the good condition of the instrument prior to the implementation of a new service contract. This instrument is required for highly sensitive assays performed on human fluids, yielding results relevant to development and establishment of biomarkers for disease.

For example, this instrument performs the neurofilament light measurements that are the most sensitive of any available method, measurements that are highly desired by scientist neurologists and researchers. Debris and air obstructions easily interfere with reliable measurements from precious, irreplaceable patient serum and spinal fluid. A service plan ensures constant access to the local field engineer to resolve issues, includes parts, repairs, and travel, as well as two preventative maintenance visits.

Interruption of the instrument’s coverage will lead to further costs and issues; a quote for a year is offered by Quanterix. Period of Performance One year base period of performance and three one-year option periods. 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.

Responses to this Notice must include clear and convincing evidence of the offeror’s capability of fulfilling the requirement utilizing OEM-certified trade-in system. In addition the Unique Entity Identifier (UEI), 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.

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. 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.

All responses must be received by 11:00 AM EDT June 18, 2024. Responses must be emailed to the Contracting Officer at sneha.singh@nih.gov and reference the Notice ID 75N95024Q00325. “All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.”