Spectradyne nCS1 nanoparticle characterization instrument

National Cancer Institute (NCI), Center for Cancer Research (CCR), Laboratory of Pathology (LP) plans to procure, on a sole source basis, a Spectradyne nCS1 instrument for high-throughput nanoparticle sizing and concentration measurements from 23875 Madison St, Suite A, Torrance, CA 90505.

This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR 13.106-1 (b)(1)(i) using simplified acquisition procedures for commercial acquisitions. The response close date of this notice for this requirement is in accordance with FAR 5.203(a)(1). The North American Industry Classification System code is 334516 and the business size standard is 1,000 employees.

The National Cancer Institute (NCI), Center for Cancer Research (CCR), Laboratory of Pathology are studying nano-sized Extracellular Vesicles (EVs) for use with precision medicine. To accurately produce, enumerate and characterize specific features of these EVs, high-throughput single EV detection and quantification using a non-optical technique is required. The Spectradyne analyzer is uniquely capable of high-throughput (10,000 events/sec) EV concentration and diameter measurements using pre-calibrated microfluific chips. This platform type of quantification is pivotal for performing any assays using EVs and is cross-compatible with orthogonal analysis methods such as nanoparticle tracking analysis utilized in the laboratory.

The intent of this requirement is to acquire a Spectradyne nCS1 instrument for high-throughput nanoparticle sizing and concentration measurements. The purpose of the instrument is to be able to perform nanoparticle measurements that will size and count single nanoparticles, including extracellular vesicles (EVs) and nanobeads. This is a key part of the EV analysis pipeline and the characterization of nanomaterials that is integral to the research being conducted in the Translational Nanobiology Section of the Laboratory of Pathology, as part of the wider NCI mission to generate and characterize new tools for cancer diagnosis and treatment.

After extensive research focused on developing and refining high-sensitivity detection technologies, NCI has identified methods and instruments that can be utilized in an integrated EV analysis pipeline to characterize the repertoires and molecular attributes of different types of EVs. A specialized instrument is required for enumeration and characterization of EVs for all downstream assays as well as assessing production. These high-throughput measurements are critical to assays utilizing these particles as all assays are concentration dependent. These measurements are also being used to standardize instrumentation, allow orthogonal comparisons, and calculate yields. This instrument will also be utilized in characterizing high-sensitivity multiparametric instrument standards using this non-optical orthogonal technique. This combination of features is essential for ongoing research and development in the Translational Nanobiology Section of the Laboratory of Pathology.

The following product features/characteristics are required for this requirement:

1. System must be capable of measuring particles from 50nm to 10µm in Equivalent Spherical Diameter (diameter of a sphere of equivalent volume).
2. Shall use resistive pulse sensing as its core technology for particle characterization (non-optical).
3. Measurements of particle size shall be independent of particle shape (i.e. "volumetric", with no assumption of shape) and material making up the particle (i.e. no reliance on index of refraction or other material property).
4. System must be able to detect differently-sized populations of nanoparticles in a complex mixture (e.g. multiple components in a drug formulation) and more importantly, accurately report the concentration of each particle size.
5. System shall use disposable microfluidic cartridges for measurement to prevent cross-contamination and eliminate cleaning.
6. Microfluidic cartridges shall be made using highly consistent nanoscale features and be factory calibrated for size and concentration measurements, therefore not requiring individual calibrations.
7. Microfluidic cartridges shall have "filtering" on-board, thereby removing particles larger than the nanoconstriction in order to prevent clogging.
8. In the event of a clog, system software shall provide a method for automatically reversing the fluid flow and sending the analyte to waste (so that fresh analyte comes to the nanoconstriction after clearing) in order to clear the clog.
9. System particle detection rate should be up to approximately 10,000 particles/sec.
This notice is not a request for competitive quotation. However, if any interested party, especially small business believes it can meet the above requirement, it may submit a capability statement for the Government to consider. The response and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 12:00 PM ET, on August 23, 2019. All responses and questions must be via email to Miguel Diaz, Contracting Officer at miguel.diaz@nih.gov. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award, contractors must be registered and have valid certification through SAM.GOV and have Representations and Certifications filled out. Reference: 75N91019Q00144 on all correspondence.

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