Human Hindbrain Organoid Functional Assay Services.

This document is a Sole Source Justification from the U.S. Food and Drug Administration (FDA) to restrict competition for human iPSC-derived hindbrain organoid functional assay services. Valued at $252,742.50, which falls below the Simplified Acquisition Threshold, the contract is slated for award to OrganoTherapeutics SARL under the authority of FAR 12.102(a). The Division of Applied Regulatory Science (DARS) requires these specialized services to evaluate how drugs and potential reversal agents affect respiratory function. The contractor must provide hindbrain organoids expressing specific biological markers and perform functional testing using 3D multi-electrode array (3D MEA) technology. The scope includes organoid production, drug treatment across multiple batches to ensure reproducibility, data analysis, and reporting. Furthermore, the testing must occur in a laboratory licensed to handle the required controlled substances. Market research evaluated six potential sources, including STEMCELL Technologies, Fujifilm, and AcceGen Biotech, but none could deliver the complete biological and functional assay requirements. OrganoTherapeutics SARL was identified as the sole capable vendor. The Contracting Officer will publicize the intent to sole-source, review any alternative capability statements received, and perform a price analysis to ensure a fair and reasonable rate before awarding the firm-fixed-price purchase order. DARS will continue monitoring the market for future competition.

This Statement of Work outlines a procurement by the Food and Drug Administration (FDA), Division of Applied Regulatory Science (DARS), for human iPSC-derived hindbrain organoids and associated materials. This contract supports the FDA's initiative to integrate human-relevant New Approach Methodologies (NAMs) to reduce animal testing and improve preclinical drug safety assessments. The procured organoids will be used for in vitro 3D microelectrode array (MEA) recordings to evaluate drug-induced changes in respiratory-relevant neural circuits. The selected vendor must meet two primary tasks over an 18-month period of performance: * **Task 1 (Supply):** Deliver human hindbrain organoids expressing specific required genes (including DBX1, SLC17A6, and OPRM1) to the FDA White Oak Campus across 12 scheduled deliveries. The first batch requires 96 organoids in a 96-well plate, followed by 11 batches of 48 organoids. * **Task 2 (Service):** Perform functional characterization in the vendor's laboratory to demonstrate organoid responses to specific drug combinations (e.g., fentanyl/naloxone, xylazine/atipamezole, d-methamphetamine/doxapram, and alprazolam/flumazenil). The vendor must establish batch-to-batch reproducibility, submit raw/analyzed data and study reports to the FDA, and return exposed drug solutions for concentration verification. No government-furnished equipment is provided. All deliverables must be coordinated with the designated FDA project officer and researcher, and will be subject to inspection and acceptance criteria.

This federal solicitation (RFQ_CDER-2026-135968), issued by the FDA Office of Acquisitions and Grants Services (OAGS), seeks Human Hindbrain Organoid Functional Assay Services. The 18-month contract is being solicited on a sole-source basis to OrganoTherapeutics SARL, though alternative responsible sources may submit quotations for consideration. The scope of work is divided into two main Contract Line Items (CLINs): 1. CLIN 0001: Providing Human Hindbrain Organoids and associated culture materials, including 12 scheduled deliveries. 2. CLIN 0002: Performing functional characterization services, including 3D Microelectrode Array (MEA) testing, drug-response studies, data analysis, study reports, and sample returns. Services must be performed at the contractor's laboratory, with deliverables sent to the FDA's Silver Spring, Maryland facility. This firm-fixed-price contract will be awarded based on a best-value determination considering technical capability, past performance, and price. Questions regarding this solicitation must be submitted by September 14, 2026. Submissions must include a technical quotation, a price quotation by CLIN, past performance information for up to three recent contracts, and confirmation of an active SAM.gov registration. Invoice submissions and payments will be managed electronically through the U.S. Department of Treasury's Invoice Processing Platform (IPP).