Quanterix__75N94022Q00098.doc

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a separate written solicitation will not be issued. This solicitation number is 75N94022Q00098 and is issued as a Request for Quotation (RFQ). The solicitation/contract will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2022-05. The North American Industry Classification (NAICS) Code is 541380 with a size standard of $16.5m. However, this solicitation is not set aside for small business. This acquisition is being conducted using Simplified Acquisition Procedures in accordance with FAR Part 13. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) intends to contract on a sole source basis with Quanterix Corporation of Billerica, MA to procure the following services for Calbindin D Assay Development:

1. TASK A: Evaluate one established antibody pair for Calbindin D and determine preliminary lower limit of detection (LLOD)

Product Code: ACC200 – Product: Custom Assay Development – Product Description: See Project as defined in attached scope of work in Quanterix' Accelerator lab. – Quantity (1)

2. TASK B: Following the determination of the preliminary LLOD using the established antibody pair, continue assay optimization and matrix evaluation on SR-X instrument.

Product Code: ACC200 – Product: Custom Assay Development – Product Description: See Project as defined in attached scope of work in Quanterix' Accelerator lab. – Quantity (1)

3. TACK C: Using the optimal assay conditions determined in Task B, perform validation studies to further define assay performance on SR-X instrument

Product Code: ACC200 – Product: Custom Assay Development – Product Description: See Project as defined in attached scope of work in Quanterix' Accelerator lab. – Quantity (1)

4. TASK D: Production of assay materials sufficient for the analysis of 300 human CSF samples

Product Code: ACC200 – Product: Custom Assay Development – Product Description: See Project as defined in attached scope of work in Quanterix' Accelerator lab. – Quantity (1)

5. REAGENT Budget Estimate/Allotment

Product Code: 101077 – Product: Misc. Accelerator Supplies – Product Description: Supplies ordered for specific customer project in Accelerator lab Services also includes: Dilutional Linearity and MRD Analysis, Standard Linearity and Assay Range, Accuracy, Repeatability, Intermediate Precision, Limit of Quantitation testing and System Suitability/Assay Acceptance System suitability and assay accept.

Quanterix has developed an approach for detecting thousands of single protein molecules simultaneously. Utilizing the same reagents as a conventional ELISA, this method has been used to measure proteins in a variety of different matrices (serum, plasma, cerebral spinal fluid, urine, cell extracts etc.) at femtomolar (fg/ml) concentrations, offering a roughly 1000-fold improvement in sensitivity. This approach makes use of arrays of femtoliter-sized reaction chambers, termed single-molecule arrays (SimoaTM) that can isolate and detect single enzyme molecules. Because the array volumes are approximately 2 billion times smaller than a conventional ELISA, a rapid buildup of fluorescent product is generated if a labeled protein is present. With diffusion defeated, this high local concentration of product can be readily observed. Only one single molecule is needed to reach the detection limit. The NIH Lab needs will be met by Quanterix due to their innate knowledge of the SRX instrument that will be used to further define assay performance because of the services/tasks that Quanterix will be providing. Not only will they be able to develop the assay but they will be able to help with troubleshooting and data analysis. This work will result in the validation of a novel neuronal based biomarkers for multiple neurodegenerative diseases. Quanterix is the manufacture of the laboratories SRX instrument as such they have the specific supplies and expertise to develop the assay in the shortest amount of time.

The proposed contract action is for supplies or services for which the Government intends to solicit and negotiate with only one source under authority of the 41 U.S.C. 253(c) (1), FAR 6.302. Only one responsible source and no other supplies or services will satisfy agency requirements. Interested persons may identify their interest and capability to respond to the requirement or submit proposals. This notice of intent is not a request for competitive proposals. However, all bids, proposals, or quotations received by the closing response date will be considered by the Government. A determination by the Government not to compete with this proposed contract based upon responses to this notice is solely within the discretion of the Government.

The offeror must include a completed copy of the provision of FAR Clause 52.212-3, Offeror Representations and Certifications – Commercial Items with its offer. The provisions of FAR Clause 52.212-1 Instructions to Offerors – Commercial Items; FAR Clause 52.212-2, Evaluation – Commercial Items; FAR Clause 52.212-4, Contract Terms and Conditions – Commercial Items; and FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items – Deviation for Simplified Acquisitions applies to this acquisition. Note: The contractor/offeror must provide a completed copy of FAR 52.204-24, "Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment" with their quote in response to this solicitation. The offeror must include their Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. The clauses are available in full text at http://www.acquisition.gov/far. Interested vendors with the capability of providing the government the needed services and consumables (if applicable) specified in this synopsis should submit a copy of their quotation to the below address or via email to robinsti@mail.nih.gov. Offers must also be accompanied by, delivery timeframe, descriptive literature, warranties and other information that demonstrates that the offer meets all the foregoing requirements. Quotations will be due seven calendar days from the publication date of this synopsis NLT April 28, 2022, by 10:00 a.m. EST. via email. The quotation must reference “Solicitation number” 75N94022Q00098 and Solicitation number 75N94022Q00098 must be on the subject line of the email. All responsible sources may submit a quotation, which if timely received, shall be considered by the agency. Quotations must be sent via email to robinsti@mail.nih.gov. Attention: Tina Robinson, by the date and time mentioned above. Any questions must be sent via email to robinsti@mail.nih.gov and must include solicitation# 75N94022Q00098 in the subject line of email.

Note: In order to receive an award, contractor must be registered and have valid certifications for all awards in the SAM database @WWW.SAM.GOV.