The Government hereby submits a notice of intent to award a sole source firm fixed price contract to Life Technologies for SeqStudio Flex genetic analyzer. IDENTIFICATION OF THE AGENCY AND THE CONTRACTING ACTIVITY: Requesting Agency: USDA APHIS WS NWRC 4101 Laporte Ave Fort Collins, CO 80521 Contracting Activity: USDA, APHIS, MRPBS, ASD Minneapolis Procurement Branch Butler Square, Fifth Floor 100 North 6th Street Minneapolis, MN 55403 NATURE AND/OR DESCRIPTION OF THE ACTION BEING APPROVED: The NWRC has created the new Wildlife Disease Diagnostic Laboratory through an initative funded by the American Rescue Plan. This laboratory will specialize in laboratory testing to detect and characterize pathogenic micoroganisms associated with wildlife. Acquisition of key major equipment is essential for building testing capacity. Here, we seek to acquire a SeqStudio Flex genetic analyzer. A DESCRIPTION OF THE SUPPLIES, EQUIPMENT, OR SERVICES REQUIRED TO MEET AGENCY NEEDS (INCLUDING THE ESTIMATED VALUE OF THE ACQUISITION INCLUSIVE OF OPTIONS): The SeqStudio Flex instrument is used for nucleic acid sequencing. The cost to acquire the SeqStudio Flex system is approximately $160K. IDENTIFICATION OF THE STATUATORY AUTHORITY PERMITTING NONCOMPETITIVE ACQUISITIONS: 41 U.S.C. 3304(a)(1), as implemented by FAR 6.302-1, titled "Only one responsible source and no other supplies or services will satisfy agency requirements." DEMONSTRATION THAT THE PROPOSED CONTRACTOR’S UNIQUE QUALIFICATIONS OR THE NATURE OF THE ACQUISITION REQUIRES USE OF THE AUTHORITY CITED: 1. The SeqStudio™ Flex 8-cap Genetic Analyzer is a 8-capillary, fluorescence-based capillary electrophoresis system used for research in genetic analysis. The SeqStudio Flex genetic analyzer can process multiple runs with up to 8 samples per run. The system is fully automated from polymer loading and replacement, DNA separation, detection and data analysis to generate base-called or size-called results. 2. SeqStudio™ Flex 8-cap Genetic Analyzer system is supplied as follows: • A capillary electrophoresis instrument • Install kits for DNA Sequencing and Fragment Analysis, including reagents and consumables for system performance check • On board touchscreen computer with integrated software for instrument control, data collection, quality control and auto-analysis of data • Dell Computer Workstation with a flat-screen monitor (optional) 3. SeqStudio™ Flex 8-cap Genetic Analyzer uses less lab bench space of width, depth, height-70 x 67.5 x 86.5 cm (27.6 x 26.6 x 34.1 in.) 4. SeqStudio™ Flex 8-cap Genetic Analyzer is designed for use with 8-tube Standard or Fast strips as well as 96wells Standard and Fast strips and 384 well plates. Samples are automatically injected directly from the 96 or 384 well microliter plates or 8-strip tubes. The system software supports the ability to perform sequencing and fragment analysis samples on the same plate. 5. SeqStudio™ Flex 8-cap Genetic Analyzer is built with a single-line 505nm, solid-state long-life laser that utilizesa standard power supply and requires no heat removal ducting. 6. SeqStudio™ Flex 8-cap Genetic Analyzer instrument is designed with pre-packaged, single use consumables as shown below: o Performance Optimized Polymers (POP-4™, POP-6™, POP-7™) available in ready-to-use, load and run, pouch format. Pouches available in three sizes: 96 samples, 384 samples and 960 samples o Conditioning Reagent Consumables available in ready-to-use load and run, pouch format. It will contain enough reagents for a single use only. o Cathode Buffer Container available as a pre-filled container with 1X buffer with two separate compartments; the left side with cathode buffer for electrophoresis and the right sidewith spent polymer waste from capillary wash between injections. o Anode Buffer Container available as a pre-filled container with 1X buffer, with a primary chamber containing buffer and a secondary overflow chamber. 7. Each of the SeqStudio™ Flex 8-cap Genetic Analyzer primary consumables are designed with an RFID (Radio FrequencyIdentification) tag integrated into the label. These labels allow tracking and reporting of the consumable usage, lot and part numbers, expiration dates and on-instrument lifetime through the instrument operation software. 8. The system software includes optional features to support: Security, Audit trail and Electronic signature features that assist with certain 21 CFR Part 11 requirements. 9. The SeqStudio™ Flex 8-cap Genetic Analyzer system files are generated in industry standard ABI format for sequencing and FSA format for fragment analysis. On a single plate, the instrument can run both Sanger sequencing and fragment analysis samples. Sample files will be compatible with secondary analysis applications for post processing such as Sequencing Analysis Software, Variant Reporter™ Software, Minor Variant Finder Software, GeneMapper™ Software and SeqScape™ software programs. For online analysis ecosystem, sequencing files can be analyzed with the Applied Biosystems™ Analysis Modules powered by Thermo Fisher Cloud, including Quality Check, Variant Analysis and Next-generation Confirmation modules. 10. The SeqStudio™ Flex 8-cap Genetic Analyzer offers ease of use capabilities including auto spectral calibration and capillary arrays with click and slide retractor tabs. 11. The SeqStudio™ Flex 8-cap Genetic Analyzer enables efficient workload management, with 4 sample plate capacity, continuous plate loading, and sample reprioritization. 12. The SeqStudio™ Flex 8-cap Genetic Analyzer can be remotely monitored using the Connect Platform for remote monitoring and data visualization via mobile device or networked device. 13. The SeqStudio™ Flex 8-cap Genetic Analyzer offers connectivity flexibility via Local Area Network (LAN), Wi-Fi, USB, and is LIMS compatible. 14. The SeqStudio™ Flex 8-cap Genetic Analyzer is supported by factory trained field service engineers for routine service, IT- to-IT Consultation Services, and validation services such as IQOQ/IPV and Computer System Validation Services (CSV). 15. The SeqStudio™ Flex 8-cap Genetic Analyzer includes a Digital Support Ecosystem which offers Smart Help and Remote Support Features for fast and secure issue resolution in addition to traditional on-site service. 16. Applications support and training is provided for the SeqStudio™ Flex 8-cap Genetic Analyzer via a staff of technical support scientists, offering support via phone, virtual, and on site. ____ This is NOT a request for quotes or proposals.The determination not to compete this proposed contract action is solely within the discretion of the Government. Information received will normally be considered for the purposes of determining whether to conduct a competitive procurement. The Government will not be responsible for any costs incurred by responding to this notice. Questions or comments to this Notice of Intent should be directed to Contracting Officer, Kim Yen Tu, at
[email protected] via e-mail only (no phone calls/voice mail messages regarding questions will not be accepted and will not receive a response).