Luminex magnetic carboxylated microsphere beads, or equivalent
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The Food and Drug Administration (FDA), specifically the Center for Biologics Evaluation and Research (CBER), is conducting market research through a Sources Sought Notice to identify potential small business sources for Luminex MagPlex or equivalent magnetic carboxylated microsphere beads. These beads are essential for fluorescent magnetic immunoassays (FMIA) in CBER's viral research and review program. This is not a solicitation for proposals. Responses are due by May 6, 2026.
Scope of Work
The FDA seeks uniquely identifiable magnetic carboxylated microsphere beads with specific physical, chemical, and functional properties. Key requirements include:
- Product: Luminex MagPlex or equivalent magnetic carboxylated microsphere beads.
- Properties: Carboxylated (COOH) surface chemistry, superparamagnetic or paramagnetic for magnetic separation.
- Functionality: Suitable for amine coupling chemistry (e.g., EDC/NHS), distinct fluorescent signatures identifiable by flow cytometry, minimum of 20 distinct bead regions for multiplex applications, compatibility with multi-laser flow cytometry systems (min 2-laser).
- Quality & Stability: Minimum 6-month shelf life from delivery, lot-to-lot consistency, free from microbial contamination, aggregation, or clumping.
- Specific Items: A detailed list of required beads (e.g., Avidin MagPlex Bead 16, Carboxylated MagPlex Bead 12) with specified 1 ml volumes.
- Delivery: Expected within 60 days of contract award to U.S. FDA/CBER, Silver Spring, MD.
Contract & Timeline
- Type: Sources Sought / Market Research
- NAICS Code: 325413 – In-Vitro Diagnostic Substance Manufacturing (Small Business Size Standard: 1,250 employees).
- Response Due: May 6, 2026, 3:00 PM Central Time.
- Published: April 29, 2026.
Submission & Evaluation
Interested parties, particularly small businesses, should submit capability statements via email to suzanne.martella@fda.hhs.gov. Submissions must include:
- Business name, Unique Entity ID (SAM), address, website, and business size status.
- Past performance (last 3 years) for similar products/services.
- Descriptive literature and technical information demonstrating product compliance.
- Identification of GSA Schedule or other applicable contracts.
- For large businesses, information on subcontracting opportunities for small businesses.
- Standard commercial warranty and payment terms, and place of manufacture. Informational pricing is helpful but not mandatory. Responses must demonstrate capability; weblinks will not be viewed.
Additional Notes
This notice is for market research only; no contract will be awarded from this announcement, and no reimbursement will be made for response costs. No RFQ package or solicitation exists. Technical points of contact will not be provided, and presentations will not be scheduled. If requirements appear restrictive, comments are encouraged. Responses to this SSN are not considered adequate responses to any future solicitation.