Refurbished Simoa HD-1 Analyzer Dx

INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA) on behalf of the NHLBI intends to negotiate and award a Purchase Order without providing for full and open competition (Including brand-name) to Quanterix Corporation, 114 Hartwell Ave, Lexington, MA, 02421,for a Refurbished Simoa HD-1 Analyzer Dx, instillation and training kit, basic kit training, and homebrew assay development. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 334516, Analytical Laboratory Instrument Manufacturing, with a Size Standard of 500 employees. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-83 03 AUG 2015. This acquisition is conducted under the procedures as prescribed in FAR subpart 13Simplified Acquisition Procedures at an amount not exceeding the simplified acquisitionthreshold ($150,000). STATUTORY AUTHORITY This acquisition is conducted under the authority of 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart 6.302-1-Only one responsible source and no other supplies or services will satisfy agency requirements 41 U.S.C. 253(c)(1). DESCRIPTION OF REQUIREMENTBackground - For over 10 years the NHLBI Flow Cytometry Core (FCC) has been involved in clinical research protocols needing measurement of soluble serum analytes. The current methodologies available can only measure these analytes at levels above a few pictograms per ml, leaving many low abundance analytes unmeasurable. The failure to adequate quantify serum analytes present in low concentrations leave significant gaps in data obtained for clinical trials. This purchase will alleviate this problem by providing the ability to measure low concentrations of serum analytes. Purpose and Objectives This request is for a factory refurbished instrument that is fully automated and capable of detecting soluble serum analytes at concentrations in the femtogram per ml ranges of concentration. Current methods to measure serum analyte in use lack this level of sensitivity. Many clinical studies require detection of these analytes at levels lower than is currently possible using other techniques. Purchasing this equipment will permit these studies and advance clinical research at NIH. Period of Performance This order will be firm fixed price. The expected delivery date is 90 days after receipt of the award. Project Description The contractor shall provide: a. Simoa HD-1 Analyzer Dx, Product code 100438-R, Quantity: 1 i. Unprecedented ultrasensitivity ii. Full automation iii. Precise, CV's of <10% iv. Wide dynamic range of > 4 logs v. Easy & cost-effective implementation vi. Multiplexing capability with small sample volumes vii. Open access platform for custom assay development (homebrew) viii. 3 plates/8hr shift; about 300 data points per day ix. Intigrated barcode reader and a cooled reagent bay x. Includes all hardware and software and two reagent packs xi. Included 1 year warranty and service b. Instrument Installation and Training Kit, product number 100712, quantity: 1. Complete kit required for instrument installation and site acceptance test, including buffers, discs, and reagent kits as follows: i. 100206: Simoa Sealing Oil (500mL bag) 1.0 EA Unit ii. 100227: Simoa Disc Kit Material 2.0 EA Unit iii. 100486: System Wash Buffer 1, (2 Pack) Material 2.0 EA Unit iv. 100487: System Wash Buffer 2, (2 Pack) Material 1.0 EA Unit v. 100722: Biohazard Bag, 24 x 23" 7-10 Gallon Material 2.0 EA Unit, Red vi. 100723: Simoa Cuvettes (50 ct) Material 1.0 EA Unit vii. 100745: Simoa HD-1 SAT Kit Material 2.0 EA Unit viii. 101071: HD-1 Calibration Kit Material 1.0 EA Unit ix. 101537: SQT - Simoa Qualification Kit 1.0 EA Unit c. Basic Kit Training, product code 101528 i. Covers all Simoa Basics ii. Run a standard kit of customers choice iii. Data analysis and troubleshooting iv. Up to three (3) trainees v. 2 days at customer site d. Home Brew Assay Development i. Prerequisite of basic training ii. Cover all Simoa basics iii. Prepare beads and detector using customer materials and/or standard HB protocol as control iv. Data analysis and troubleshooting v. Assay development for a HB assay e. Shipping Other Important Considerations Training must be provided by Quanterix approved and authorized personnel. 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 as prescribed in FAR Part 10-Market Research, specifically the review and evaluation of the responses to the sources sought notice published in the FedBizOpps on August 19th, 2015 for a period of 13 days; NHLBI-CSB-HL-217-KEW-SBSS. No other company provided a capability stement stating they could provide the Simoa HD-1 Analyzer. Quanterix, the manufacturer of the Simoa HD-1 Analyzer is the only company capable of providing the factory refurbished Simoa HD-1 Analyzer. No other company is capable of providing a new or factory refurbished Simoa HD-1 analyzer. The system is unique due to it's fully automated, bead-based system for quantification of serum analytes at the femtogram per ml range, no other product offers the automation and sensitivity at this level. 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 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 Dun & Bradstreet Number (DUNS), 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." 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 September 8th, 2015 9:00 AM EST and must reference number NHLBI-CSB-HL-2015-244-KEW. Responses may be submitted electronically to Kyle Wisor, Kyle.Wisor@nih.gov, or by U.S. mail to the National Heart, Lung, and Blood Institute, Office of Acquisitions, COAC Services Branch,6701 Rockledge Drive, Suite 6150B, Bethesda, MD 20892-7902, Attention: Kyle Wisor. Fax responses will not be accepted. "All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency."