Human Hindbrain Organoid Functional Assay Services.
Closed Solicitation Posted
- Solicitation number
- RFQ_CDR-2026-135968
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541714 Research and Development in Biotechnology (except Nanobiotechnology)
Notice details come from SAM.gov. Updated .
About this opportunity
The FDA's Center for Drug Evaluation and Research seeks human iPSC-derived hindbrain organoid functional assay services on a sole-source basis to OrganoTherapeutics SARL, with quotations due September 17, 2026, and questions due September 14, 2026 at 10:30 AM ET.
This is a firm-fixed-price commercial service acquisition under FAR Part 12. The sole-source restriction reflects market research determining that OrganoTherapeutics SARL is the only identified source capable of providing human hindbrain organoids exhibiting the required biological marker expression (DBX1, SLC17A6, TACR1, SST, OPRM1, KCNJ6, ARRB2, ADRA2A, SLC6A2, NALCN, SCN8A, and CACNA1H) paired with functional characterization services. The contractor must deliver hindbrain organoids across twelve scheduled shipments over an eighteen-month period of performance, beginning with 96 organoids in the first delivery and 48 organoids in each of eleven subsequent deliveries, to the FDA White Oak Campus in Silver Spring, Maryland.
The scope requires functional characterization using three-dimensional multi-electrode array technology to assess electrophysiological responses to FDA-identified drug and reversal-agent combinations (fentanyl/naloxone, xylazine/atipamezole, d-methamphetamine/doxapram or CX717, and alprazolam/flumazenil). The contractor must perform testing at its own facility and deliver raw data, analyzed data, analysis files, and study reports. Work must be conducted in a laboratory licensed to handle controlled substances. Deliverables include batch-to-batch reproducibility evaluation and collection of exposed drug solutions for FDA verification. Award value is $252,742.50. Evaluation weighs technical capability and past performance (combined as most important) over price. NAICS code is 541714; PSC is B504. All shipping and transportation costs to Silver Spring are included in quoted prices.
Notice text
The U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Division of Applied Regulatory Science (DARS), intends to award a sole-source, Firm-Fixed-Price purchase order to OrganoTherapeutics SARL for Human iPSC-Derived Hindbrain Organoid Functional Assay Services.
The requirement includes the provision of human induced pluripotent stem cell (iPSC)-derived hindbrain organoids and associated materials necessary to support in vitro research evaluating drug-induced effects on respiratory-relevant neural circuits. The contractor will also perform functional characterization of the organoids using three-dimensional multi-electrode array (3D MEA) technology to assess electrophysiological responses to drugs known to affect respiratory function.
The functional characterization includes testing FDA-identified drug and reversal-agent combinations, MEA measurements, evaluation of batch-to-batch reproducibility, collection of exposed drug solutions for FDA verification, data analysis, and delivery of raw data, analyzed data, analysis files, and study reports.
The requirement also includes twelve scheduled deliveries of human hindbrain organoids to the FDA White Oak Campus. The first delivery will consist of 96 organoids, with subsequent deliveries consisting of 48 organoids each. Functional characterization will be performed at the contractor's laboratory.
The anticipated period of performance is eighteen (18) months from the date of award.
This acquisition is being conducted as a commercial service acquisition under RFO FAR Part 12. The Government's decision to restrict competition is documented pursuant to RFO FAR 12.102(a). Market research identified OrganoTherapeutics SARL as the only source capable of satisfying the Government's complete requirement for both the required human hindbrain organoids and associated functional assay services.
This notice is not intended to restrict consideration of any responsible source capable of meeting the Government's complete requirement. All responsible sources may submit a quotation and supporting capability information by the response date identified in this notice. Any timely response demonstrating the capability to satisfy the Government's complete requirement will be considered by the Contracting Officer prior to award.
NAICS: 541714
PSC: B504 – Special Studies/Analysis – Chemical/Biological
Place of Delivery: FDA White Oak Campus, Silver Spring, Maryland
Place of Service Performance: Contractor's laboratory
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