Purification System
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 National Center for Toxicological Research (NCTR) Division of Biochemical Toxicology to require Purification System that will extract nucleic acids in a 96 well format, using superparamagnetic particle (magnetic beads) technology. This type of instrumentation will optimize the ability to uniformly extract nucleic acids from small volumes of body fluids and cell culture medium while enabling the processing of many samples and extract nucleic acids to accurately identify and quantify biomarkers, including circulating microRNAs, in biological samples and culture media.
The FDA is seeking small business sources to determine the availability and capability of small business manufacturers or small businesses capable of supplying, a U.S. made product of a small business manufacturer or producer for the items described herein. 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; 1,000 employee Small Business Size standard.
The FDA/NCTR/Division of NCTR Division of Biochemical Toxicology requires Purification System that will extract nucleic acids in a 96 well format, using superparamagnetic particle (magnetic beads) technology.
Technical Specifications Purification System are:
1. Shall be able to extract RNA, DNA, and protein from low volume body fluid and/or cell culture medium samples (25.0 ul serum) from 8 to 96 samples at one time, in an automated system
2. Shall be able to use superparamagnetic particle (magnetic beads) technology, in which the beads are moved instead of transferring liquids.
3. The system shall be optimized to process serum samples using an appropriate total RNA isolation kit. The MagMax mirVana Total RNA Isolation kit has been optimized and is currently used in the laboratory for the manual isolation of serum microRNAs.
4. Shall be able to uses reagent consumables which are matched specifically to the instrument to ensure uniformity and pure nucleic acids for downstream applications.
5. An automated system shall have the capability to eliminate hands-on processes such as ethanol precipitation, phenol/chloroform extraction, and centrifugation.
6. Automation system is enclosed to prevent outside contamination of samples
7. Automation system shall be used with multiple magnetic particle bead kits for the purification of genomic DNA, plasmid DNA, total RNA, mRNA, PCR products, whole cells and proteins from a variety of starting matrices (including serum, frozen and paraffin embedded tissues, cells, bone, feces, bacteria, swabs, etc.).
8. Shall work with any magnetic bead system
9. Shall have software that allows users (and kit manufacturers) to write and modify protocols and then upload them to the instrument
10. Utilizes a low elution volume to maximize nucleic acid concentration
11. Shall have a snap-on heat block for applications requiring temperature control
12. Shall have a one-day training session
13. Shall include at least a one-year warranty
FOB Point Destination. All items shall include shipping, handling and in-side delivery to the destination identified herein. Delivery/installation completed within 30 days after receipt of order. FOB Point of Delivery for Services and Supplies will be the FDA NCTR facility located at 3900 NCTR RD, Jefferson, AR 72079.
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 of a small business manufacturer or producer all interested parties may respond. At a minimum, responses shall include the following:
• Business name, DUNS 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, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement.
• Three (3) years of past performance information for the manufacture, and/or sale and support in which the offeror has provided same or substantially similar products and used for same or near-same applications as set forth herein. 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 DUNS 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.
•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; and
•Though this is not a request for quote, informational pricing is encouraged.
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 on or before August 21, 2018 by 12:00 hours (Central Time in Jefferson, Arkansas). Reference FDA1201532.
Notice of Intent
Responses to this source 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 FedBizOpps. 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).
ROOSEVELT D. WALKER, CONTRACT SPECIALIST, Phone 8705437405, Email roosevelt.walker@fda.hhs.gov
