SAM #75F40126Q22123

FDA Procurement of Illumina MiSeq i100 Whole Genome Sequencing System for IRVLMP

The Food and Drug Administration (FDA), through its Office of Acquisitions and Grants Services and the Irvine Medical Products Laboratory (IRVLMP), is seeking to procure a next-generation whole genome sequencing system for microbiological testing of pharmaceutical samples. - Government Buyer: - U.S. Food and Drug Administration (FDA) - Office of Acquisitions and Grants Services (OAGS), Facilities Support Branch (FSB) - Irvine Medical Products Laboratory (IRVLMP) - OEMs and Vendors: - Illumina (sole-source, Original Equipment Manufacturer) - Products/Services Requested: - Illumina MiSeq i100 Whole Genome Sequencing System (1 unit) - Includes onboard software, monitor, control computer - Sequencing-by-synthesis next-generation sequencing technology - Output: up to 25 Gigabases, up to 50 million paired-end reads per run - Max read length: at least 2 x 300 base pairs - 85% bases achieving Q30 at 2 x 300bp - RFID or equivalent consumable tracking - Reagents stored at room temperature - Benchtop system not exceeding 16 x 18 x 26 inches (WDH) - Compatible with existing validated laboratory workflows, consumables, and analytical methods - Delivery and installation at FDA IRVLMP, Irvine, CA - Training for up to three end-users upon installation and prior to government acceptance - One-year manufacturer warranty covering all parts, labor, and operational support - Unique or Notable Requirements: - Sole-source justification: Only Illumina MiSeq i100 is compatible with FDA IRVLMP's validated workflows and consumables - Delivery required within 60 days after award - Option to extend services for up to 6 months - System must be fully compatible with existing laboratory software environments and operational procedures - All components, software, and warranty support must be included

Description

This requirement is for the acquisition of one (1) Illumina MiSeq i100 Whole Genome Sequencing System for the FDA Irvine Medical Products Laboratory (IRVLMP). The procurement is being conducted on a sole-source basis under RFO FAR Part 12 and FAR 13.106-1(b)(1), as the Illumina MiSeq i100 System is the only system determined capable of meeting the Government’s minimum requirements for compatibility with existing validated laboratory workflows, consumables, sequencing methods, software environments, and operational procedures. The requirement includes associated components, software, delivery, installation, training, and manufacturer warranty support.

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