Evaluating the utility of bulk RNA transcriptomics

Closed Solicitation Posted

Solicitation number
FDA-CDER-25-128751
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

Place of performance
Silver Spring, Maryland 20993, United States

Notice details come from SAM.gov. Updated .

About this opportunity

The Food and Drug Administration's Center for Drug Evaluation and Research is seeking a contractor to perform bulk RNA transcriptomics analysis on primary human hepatocytes to assess drug-associated adverse liver events. The solicitation requires comprehensive genomic services including quality control checks of RNA samples, total RNA sequencing using NovaSeq X Plus platform, and data analysis reporting to identify changes in both coding and noncoding RNAs following treatment. The contractor must provide 800 RNA sequencing tests, 400 basic analyses, and 6 data handling tasks over a 12-month period of performance. Evaluation will be based on technical understanding, key personnel qualifications, and pricing, with technical factors weighted significantly more than price. Proposals are due by 3:00 p.m. Eastern Time on July 16, 2025, and must be submitted electronically to the contract specialist.

This solicitation is designated as a firm-fixed price purchase order with no set-aside restrictions, making it open to full and open competition. The contract value has not been specified in the documentation, as it will be determined through the proposal process. Key technical requirements include paired-end 150bp sequencing generating approximately 100 million total reads per sample, with RNA samples to be delivered in a single batch of 800 samples extracted in-house by the government. The work will be performed with a focus on Silver Spring, Maryland, and contractors must use Illumina as the required sequencing platform. Data deliverables include raw data files, QC reports, mapping output, and alignment statistics, with transfer capabilities via self-hosted sFTP explicitly required while AWS delivery options are not acceptable.

Notice text

The objective of this contract is to obtain service required to complete bulk transcriptomics of RNAs from treated and untreated primary liver hepatocytes. Transcriptomics data generated from bulk RNA sequencing will identify changes occurring for both coding and noncoding RNAs in primary human hepatocytes (PHHs) following treatment.

Obtain the service required to complete bulk RNA sequencing or transcriptomics from treated primary liver hepatocytes (PHHS). Transcriptomics data generated from bulk RNA sequencing will quantify expression of both coding and noncoding RNAs in PHHs.

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