Real-Time PCR System

Active

Contract Opportunity

MARKET RESEARCH PURPOSES ONLY

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

The U.S. Food and Drug Administration (FDA) is conducting market research to support the Humans Food Program (HFP) requirement for a new Real-Time PCR Platform for Seafood Analysis.

The FDA is seeking small business sources to determine the availability and capability of small businesses capable of providing the required products/services. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort.

The associated North American Industry Classification System (NAICS) Code is- 334516 – Analytical Laboratory Instrument Manufacturing; the applicable Small Business Size Standard is 1000 employees.

Statement of Work

Title: Purchase of a new Real-Time PCR Platform for Seafood Analysis

Purpose

The purpose of this requirement is to acquire a new real-time PCR platform to update, develop, optimize, and validate new and existing BAM methods for detecting and quantifying viral and bacterial pathogens in seafood.

Background

Food and Drug Administration (FDA) laboratories commonly use molecular methods to identify pathogenic microorganisms in food samples as part of the Human Foods Program (HFP). Currently, laboratories use the Applied Biosystems™ 7500 FAST real-time PCR platform, which is the only platform on which all FDA and National Shellfish Sanitation Program (NSSP) regulatory assays have been validated. Recently, ThermoFisher Scientific (the parent company of Applied Biosystems) announced that the Applied Biosystems™ 7500 FAST real-time PCR platform will be discontinued as of October 31, 2025. Therefore, there is an urgent need to purchase a replacement real-time PCR platform to use for all food product testing and research within the FDA. This new real-time PCR platform will be used to develop and/or validate new methods and modify optimize, if necessary, existing molecular methods for continued use in the HFP.

Salient Characteristics

The real-time PCR system must be capable of, and include the following:

• Real-time PCR instrument with the following capabilities:
  
  
  
  • Ability to run 96 samples at one time, each with a sample volume of 25 microliters (µL)
  
  
  • Compatibility with the following consumables for analyzing samples: 96 well plates, 8 tube strips, optical cap strips, and optical films
  
  
  • Six channels for reading emission spectra from fluorescent probes, with the ability to multiplex five targets with a reference dye
  
  
  • Ability to read Cy5, Cy3, FAM, JOE, ROX, VIC, HEX, TEXAS RED and NED dyes or fluorophores
  
  
  • Ability to perform in-house spectral calibrations, background calibrations, and ROI calibrations with commercially available calibration kits
  
  
  • Ability to include a passive reference dye in multiplexed assays
  
  
  • Excitation range of at least 450 – 680 nanometers (nm)
  
  
  • Emission range of at least 500 – 730 nanometers (nm)
  
  
  • Minimum average temperature ramp rate of at least 3.5 degrees Celsius (°C)
  
  
  • Temperature uniformity of at least 0.4 degrees Celsius (°C) and temperature accuracy of at least 0.25 degrees Celsius (°C)
  
  
  • Ability to control instrument through a connected computer (desktop or laptop)
  
  
  • 115 Volt electrical requirements
  
  
  
  


• Computer with appropriate analysis software with the following features:
  
  
  
  • Laptop or desktop computer with Windows operating systems
  
  
  • Ability to input and change run parameters (temperatures, duration, number of cycles, number of steps in each cycle)
  
  
  • Ability to label samples with fluorescent dyes, sample names, quantities of target
  
  
  • Ability to change analysis settings, such as background cycles and threshold values
  
  
  • Software transforms fluorescence readings into Critical Threshold (Ct) or Cycle of Quantification (Cq) values
  
  
  • Ability to view amplification curves in log or linear views
  
  
  • Ability to view multicomponent plot with raw fluorescence data
  
  
  • Ability to analyze standard curve data and calculate quantities of target present in unknown samples
  
  
  
  

Deliverables:

Deliverable Quantity Delivery Date

Real-Time PCR Instrument 1 Within 45 calendar days of award.

Computer with analysis software 1 Within 45 calendar days of award.

Shipping Destination

FDA Gulf Coast Seafood Lab

COR: To be provided at time of award.

1 Iberville Drive

Dauphin Island, AL 36528

The delivery or services must be during regular business hours (Monday-Friday) during the times of 8:00 AM – 4:00 PM, excluding holidays.

Installation, Testing and Training Requirements:

The Contractor shall provide all labor, travel, and tools to install the equipment at the address provided below, to include inside delivery. The equipment shall be tested once installed to verify all aspects of the system are operating within parameters of the required specifications. The Contractor shall demonstrate upon completion of installation and testing that the item meets all specifications. Contractor shall provide training to program office personnel on the operation of the system.

All standard information on the equipment, including but not limited to User Manuals, Operation and Maintenance (O&M) Manuals, Material and Safety Data Sheets (MSDS), troubleshooting guides and any other applicable documentation, shall be provided upon installation of the system. Upon acceptance of the system, training shall be provided to a minimum of two (2) attendees/users by the Contractor’s trained and certified personnel.

The components and equipment shall be newly manufactured, not used or refurbished, or previously used for demonstration.

Offered systems shall be a turn-key solution i.e., the contractor shall be responsible for providing all hardware, components, instruments, computers, software, and that otherwise required to meet these specifications and the FDA’s stated need.

The systems shall be delivered with all necessary supplies and accessories required for installation and start-up.

System shall be warranted for not less than one (1) year from FDA acceptance of the system(s) to include on-site training. Warranty service shall include troubleshooting capabilities based on complete knowledge of the entire system, immediate access to replacement parts, and immediate access to system improvements and updates. Phone and email technical support shall be included for a minimum of one (1) year. One (1) preventative maintenance visit per during the warranty period inclusive of all labor, travel, and parts, components, subassemblies, etc. necessary to provide the service.

FOB Point Destination. All items shall include shipping and handling to the destination identified herein.

Alternative solutions will be considered insofar as any such alternate system and/or system components meet the minimum intended use of the system and brand name or equal technical requirements.

The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product/service of a small business manufacturer or producer all interested parties may respond. At a minimum, responses shall include the following:

• Business name, SAM Unique Entity ID number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address (Provide this same information if responding to provide a product manufactured by another firm);


• Sufficient descriptive literature that unequivocally demonstrates that offered products and services can meet the above requirements. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including technical specifications, ISO certifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement.


• Three (3) years of past performance product/service information, where the respondent has provided same or substantially similar products/service solutions on the same or near-same brand name equipment. For each past performance reference include the date of sale, description, dollar value, client name, client address, client point of contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include SAM Unique Entity ID number and size status) if not the respondent.


• If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. Detailed list of items included and not included on the GSA contract to meet this requirement.


• If applicable, identification of Best in Class (BIC) contract information or other Government-wide or HHS-wide contracts that the equipment/service is available on.


• Capability and understanding of accessibility testing and customization to conform with the applicable Section 508 standards identified herein. Provide information if the respondent has an Accessibility Conformance Report (ACR) for the products offered for the Revised 508 Standards. The ACR should be based on the Voluntary Product Accessibility Template Version 2.0 (MS Word) provided by the Industry Technology Industry Council (ITIC).


• Offerors shall be prepared to submit the following information for MAT List Approval should a solicitation come out or with this technical capability response. Offerors if/when a solicitation comes out will only have a limited number of days (7) to submit the documentation.
  
  
  
  • Version/Model number of the proposed software.
  
  
  • Description of what your software does (if the software contains a suite of products, please provide the function of each product contained within the suite.
  
  
  • All specs to the Computer
  
  
  • Website URL for Software and computer, when available.
  
  
  
  


• Provide information if any of these specifications are too restrictive. No response will be considered that the listed specifications are adequate in a competitive environment.


• If a large business, identify the subcontracting opportunities that would exist for small business concerns;


• Standard commercial warranty and payment terms;


• Provide place of product manufacture or service performance and any other applicable information to enable review and analysis pertaining to the Buy American statute and requirements relating to Made in America in the event a nonavailability waiver request through the MIAO Digital Waiver Portal is needed; and


• Though this is not a request for quote, informational pricing is encouraged for both the purchase of the monitoring, gas and delivery.

The government is not responsible for locating or securing any information, not identified in the response.

The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation.

Interested Parties shall respond with capability statements which are due by email to the point of contact listed below on or before May 6, 2025 by 13:00 hours (Central Time in Jefferson, Arkansas) to nick.sartain@fda.hhs.gov. Reference HFP-2025-128425.

Notice of Intent

Responses to this sources sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures.

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 sam.gov. 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).

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