Benchtop Flow Cytometer System
INTRODUCTION
This is a Small Business Sources Sought (SBSS) notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice.
This notice is issued to help determine the availability and type of qualified Small Business companies technically capable of meeting this potential government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. The notice is strictly for research and information purposes only.
The information requested will assist the Government in determining the appropriate acquisition method including small business socio-economic set-aside possibilities and to determine the availability of qualified Small Business companies technically capable of meeting the Government's potential requirement. All Small Business companies with the capability and availability to perform the requirement under the applicable NAICS code are invited to submit a response to this notice.
NORTH AMERICAN CLASSIFICATION SYSTEM (NAICS) CODE
The NAICS code applicable to this requirement is 334516 Analytical Laboratory Instrument Manufacturing with size standard 1000 employees.
BACKGROUND
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. The National Center for Advancing Translational Sciences (NCATS) is a translational science center whose mission is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions.
The Therapeutics for Rare and Neglected Diseases (TRND) program at NCATS supports pre-clinical development of therapeutic candidates intended to treat rare or neglected disorders, with the goal of enabling Investigational New Drug (IND) candidates. TRND projects are selected based on their potential to move forward into human trials and transform patient care for rare and neglected diseases. Each project has the potential for success and ability to teach important lessons about rare and neglected disease drug development.
The TRND biology program's mission is to encourage and speed the development of new treatments for diseases with high-unmet medical needs. The TRND biology program has a potential requirement for a benchtop flow cytometer system to apply the tools of small molecule screening and discovery to the development of chemical probe research tools, for use in the study of protein and cell functions, and biological processes relevant to physiology and diseases TRND is currently studying.
Purpose and Objectives
This Small Business Sources Sought notice seeks to determine eligible sources capable of achieving the essential features of this potential requirement. The purpose of this potential requirement is to obtain one (1) flow cytometer system in accordance with the essential features described in this notice.
TRND currently has multiple projects for rare and neglected diseases including Zika virus, Ebola virus, AAV9 gene therapy for muscular dystrophy, NPC, and induced pluripotent stem cells (iPSCs) studies with an increasing portfolio of induced pluripotent stem cell projects that need to be supported by a lightweight and ergonomic flow cytometer system meeting the essential features described in this notice.
Project Requirements
Specifically, the following features are deemed essential that this potential requirement shall possess:
Power requirements: Input 12 VDC, Power: 90 VA
18-27 detection channels to maximize signal detection and provide flexible configuration options for Forward scatter (FSC), side scatter (SSC) and 16~25 fluorescent detection channels.
16~25 independent silicon photomultipliers (SiPM) detectors for collecting and processing signals from each of all 16~25 fluorescent channels.
Upgradeable to add extra fluorescence channels from 16 up to 25.
Four excitation lasers (405nm, 488nm, 640nm, 561nm) at the 100mW output power to maximize fluorophore options and detections sensitivity.
Ability to detect and resolve particles of size down to 100nm with FSC and SSC.
Fluorescence threshold sensitivity of FITC <50 MESFs, APC <15 MESFs, Pacific Blue <30 MESFs, PE <20 MESFs to enable detection of weak signals or rare populations.
Fluorescent linearity: R squared >0.99.
Spatially separated beams with 10x60uM small beam spot to minimize emission signal overlap.
User-exchangeable filters with embedded "smart" sense to prevent errors.
Fixed optics requiring no operator alignment.
7.2 log dynamic range, eliminating the need to set detector voltages and simplifying instrument setup.
Rectangular quartz flow cell 170 x 290µm to minimize the chance of clogs.
Sample acquisition rate of 50,000 events/seconds to enable rapid data acquisition and efficient sample processing.
Sample input formats with stationary single tube holder with 12x75mm falcon tube and stationary single e-tube holder with 1.5mL or 2mL Eppendorf tube.
Carryover at < 0.1% volume.
Absolute cell count capability and counting performance of <5% CV.
Retractable probe and a built-in probe decontamination fluidics system to eliminate the possibility of cross-contamination between samples during acquisition.
Software package that enables: the operation, maintenance and troubleshooting of the flow cytometer with both data acquisition and analysis that is fully integrated into the flow cytometry system and offers all the tools needed to collect and analyze data and data export in FCS 3.0, FCS 31, and CSV formats for third-party software analysis, drag-and-drop software templating function for rapid application of settings and analysis across multiple samples, automatic compensation and a quick compensation function allow for the rapid generation of compensation matrices, ability to acquire and analyze data simultaneously in conjunction with the operating system, cell proliferation analysis module to expand the data analysis capability to model the proliferation assay data, built-in cell cycle analysis function (Watson pragmatic model and Dean-Jett-Fox model) for enhanced data analysis capability and to eliminate the need for third party software, a heat map function to enable the convenient visualization of the statistical results for multiple parameters from multiple samples, bi-variate plot function to visualize an array of fluorescence data plotted against each other and the impact of fluorescence compensation on the results, and technical controls implemented for requirements related to 21 CFR part 11 compliance for electronic signatures and records.
Negative-pressure sample acquisition to minimize ambient room noise.
Operating temperature range of 15 to 30 degrees centigrade, enabling optimal performance while lessening the strain on the building's HVAC system.
Simple, automated, fast, one-button procedures for Startup, Cleaning, Decontamination and Shutdown.
Instrumentation and consumables that are manufactured in an ISO 9001 environment.
Contractors submitting a response to this Small Business Sources Sought notice shall possess the ability to achieve the salient government essential features of this potential requirement. Specifically, Offerors to this Small Business Sources Sought notice shall document evidence of being able to provide the subject supply that will allow for the essential features described herein to be accomplished.
Delivery/Warranty
Offerors should indicate an estimated delivery time in full after receipt of an order and any other training or warranty or software license considerations applicable. Inspection and acceptance will be performed at NCATS located at 9800 Medical Center Drive, Rockville, MD 20852.
CAPABILITY STATEMENTS/INFORMATION SOUGHT
Interested parties are expected to review this notice to familiarize itself with the requirements of this project. Failure to do so will be at your firm's own risk.
Respondents must provide, as part of their response: (a) product, catalog, model, and/or part number(s); (b) product description; (c) all relevant information and documentation that the item(s) offered meets the salient physical, functional, or performance characteristics as specified in this announcement; (d) quantity; (e) shipping, handling, and/or installation instructions, and/or any special delivery conditions after receipt of an order.
Respondents that believe that they are manufacturers or authorized re-sellers of the equipment specified in this announcement must provide, as part of their response: (a) product, catalog, model, and/or part number(s); (b) product description; (c) all relevant information and documentation that the item(s) offered meets the salient physical, functional, or performance characteristics as specified in the purchase description; (d) quantity; (e) estimated price or cost; (f) shipping, handling, and/or installation charges; and delivery date after receipt of order.
The respondent must also provide their DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc.) pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements.
The information submitted must be in outline format that addresses each of the elements of this requirement. A cover page and an executive summary may be included but is not required.
The response is limited to ten (10) pages. The 10-page limit does not include the cover page, executive summary, or references, if requested.
The response must include the respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses.
Respondents must reference the announcement number on all correspondence related to this Small Business Sources Sought notice. The response must be submitted to Hunter Tjugum electronically, at hunter.tjugum@nih.gov, and be received prior to the closing date specified in this announcement.
CONCLUDING STATEMENTS
Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.
Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
Hunter A Tjugum, Contract Specialist, Phone 3018275304, Email hunter.tjugum@nih.gov
