B08_SOL__Attachment_1_Statement_of_Need.docx

STATEMENT OF NEED (SON)

1.0 TITLE

Element Biosciences AVITI™ 24 sequencing and spatial biology system

2.0 BACKGROUND

The purpose of this acquisition is to enhance the shared research capabilities of the National Cancer Institute (NCI), Center for Cancer Research (CCR), by acquiring an Element Biosciences AVITI24 Sequencing System for joint operation by the CCR Genomics Core and the CCR High-Throughput Imaging Facility (HiTIF). The AVITI24 will expand existing next-generation sequencing (NGS) capacity while introducing integrated high-resolution imaging, spatial cytoprofiling, and direct in situ sequencing capabilities that are not currently available through existing CCR institutional resources.

The CCR Genomics Core provides advanced genomics technologies and bioinformatics support to investigators across NCI's intramural research programs. Demand for high-throughput sequencing continues to increase as investigators pursue complex studies in cancer genomics, transcriptomics, precision oncology, biomarker discovery, and translational research. Adding the AVITI24 will increase sequencing capacity, improve operational flexibility, reduce turnaround times, provide continuity during maintenance or downtime on existing instruments, and improve cost efficiency through flexible run configurations and efficient reagent utilization.

The AVITI24 will complement the Genomics Core's existing Illumina sequencing platforms by allowing projects to be assigned to the most cost-effective and technically appropriate instrument. This multi-vendor strategy will reduce reliance on a single sequencing technology, improve scheduling flexibility, and minimize service disruptions associated with instrument maintenance, downtime, or capacity constraints.

HiTIF will use the AVITI24 to support high-resolution spatial cytoprofiling and functional genomics workflows. The system functions as a sequencing microscope by integrating high-resolution imaging with direct in situ sequencing, enabling simultaneous measurement of cellular morphology, protein expression, and transcriptomic information at single-cell resolution. These capabilities support highly multiplexed spatial profiling applications, including Cell Painting assays, multi-parameter immunofluorescence, direct mRNA in situ sequencing, mutation detection, splice variant analysis, immune receptor sequencing, and identification of barcoded perturbations in optical pooled screening experiments.

The AVITI24 is particularly aligned with HiTIF's growing optical pooled screening (OPS) program. HiTIF currently supports multiple OPS projects in collaboration with CCR investigators and anticipates continued growth in demand for these assays. The AVITI24 will provide the molecular readout needed to link phenotypic imaging data with genetic perturbations and transcriptional responses at single-cell resolution, creating capabilities that are not currently accessible to CCR researchers through existing institutional resources.

Both core facilities completed a six-month manufacturer-sponsored evaluation of the AVITI24. The evaluation demonstrated high-quality sequencing performance, compatibility with existing library preparation workflows, integration with current analysis pipelines, and strong spatial biology performance. Acquiring the AVITI24 as a shared institutional resource will expand access to advanced sequencing and spatial cytoprofiling technologies, reduce reliance on external service providers, improve operational efficiency, and support the growing research needs of CCR investigators.

3.0 TYPE OF ORDER

This acquisition will be made as a Firm Fixed-Price Purchase Order.

4.0 SPECIAL ORDER REQUIREMENTS

4.1 Product Features / Salient Characteristics

The system shall meet the following minimum requirements:

· Provide integrated next-generation sequencing, high-resolution imaging, spatial cytoprofiling, and direct in situ sequencing capabilities on a single instrument.

· Generate high-throughput sequencing data suitable for operation in a shared core facility environment and for performance comparable to current industry-standard sequencing platforms.

· Provide flexible sequencing configurations, including support for multiple flow cell formats and independent run scheduling, to accommodate projects with different throughput and turnaround requirements.

· Accept standard sequencing libraries generated using existing laboratory workflows without requiring additional library conversion or extensive redevelopment of validated methods.

· Use efficient reagent and consumable workflows that improve productivity, support cost-effective project assignment, and reduce turnaround times.

· Support spatial cytoprofiling at single-cell resolution by integrating high-resolution fluorescence imaging with sequencing-based molecular readout.

· Enable simultaneous detection or measurement of RNA, protein, and cellular morphology from the same sample, reducing the need to split samples across separate assays or integrate data generated on separate instruments.

· Support highly multiplexed spatial biology applications, including RNA profiling, protein detection, morphology profiling, mutation analysis, splice variant detection, immune receptor profiling, and optical pooled screening.

· Support direct in situ sequencing or equivalent direct in-sample sequencing workflows for identifying barcoded perturbations and linking imaging phenotypes to genetic perturbations and transcriptional responses.

· Provide subcellular-resolution imaging suitable for cell segmentation, spatial feature extraction, and high-content cytoprofiling workflows.

· Support high-throughput spatial profiling suitable for large-scale perturbation screens, drug-response profiling, and single-cell imaging studies.

· Provide onboard instrument control, automated run setup, quality monitoring, image acquisition, sequencing analysis, primary data processing, and data export.

· Include software for instrument operation, run monitoring, imaging, sequencing analysis, spatial cytoprofiling analysis, and data export compatible with institutional computing infrastructure, including downstream analysis pipelines used by CCR investigators.

· Support remote system monitoring, diagnostics, software updates, and manufacturer-supported maintenance.

· Include all hardware, optics, imaging components, computing hardware, software licenses, accessories, and other components necessary for full operation of the system.

· Be delivered, installed, tested, validated, and fully operational upon completion of installation and Government acceptance testing.

· Include manufacturer warranty coverage, technical support, and user training for Genomics Core and HiTIF personnel.

4.2 Delivery and Installation

The Contractor shall deliver and install the system within four to twelve weeks after contract award at the following location:

Liz Conner CCR Genomics Core National Cancer Institute 37 Convent Drive, MSC 4256 Bethesda, MD 20892-4256 Phone: 240-760-7373 Email: liz_conner@nih.gov

4.3 Training

The Contractor shall provide training on the proper use of the equipment, software, consumables, and associated sequencing and spatial cytoprofiling workflows for NCI personnel at the delivery location. Training shall be conducted within one week of installation, unless otherwise agreed to by the Government, and shall be provided by Element Biosciences application specialists, field service engineers, premium support scientists, or other qualified manufacturer-authorized personnel. Additional training and technical support shall be available on an as-needed basis during implementation.

1.0 PAYMENT

Payment shall be made once after delivery and installation of equipment, upon government acceptance. Payment authorization requires submission and approval of invoices to the COR and NIH OFM, in accordance with the payment provisions listed below:

The following clause is applicable to all Purchase Orders, Task or Delivery Orders, and Blanket Purchase Agreement (BPA) Calls: PROMPT PAYMENT (JUL 2013) FAR 52.232-25. Highlights of this clause and NIH implementation requirements follow:

I INVOICE REQUIREMENTS

A. An invoice is the Contractor's bill or written request for payment under the contract for supplies delivered or services performed. A proper invoice is an "Original" which must include the items listed in subdivisions 1 through 12, below, in addition to the requirements of FAR 32.9. If the invoice does not comply with these requirements, the Contractor will be notified of the defect within 7 days after the date the designated billing office received the invoice (3 days for meat, meat food products, or fish, and 5 days for perishable agricultural commodities, dairy products, edible fats or oils) with a statement of the reasons why it is not a proper invoice. (See exceptions under II., below.) Untimely notification will be taken into account in the computation of any interest penalty owed the Contractor.

1. Vendor/Contractor: Name, Address, Point of Contact for the invoice (Name, title, telephone number, e-mail and mailing address of point of contact).

2. Remit-to address (Name and complete mailing address to send payment).

3. Remittance name must match exactly with name on original order/contract. If the Remittance name differs from the Legal Business Name, then both names must appear on the invoice.

4. Invoice date.

5. Unique invoice #s for all invoices per vendor regardless of site.

6. NBS document number formats must be included for awards created in the NBS: Contract Number; Purchase Order Number; Task or Delivery Order Number and Source Award Number (e.g., Indefinite Delivery Contract number; General Services Administration number); or, BPA Call Number and BPA Parent Award Number.

7. Data Universal Numbering System (DUNS) or DUNS + 4 as registered in the Central Contractor Registration (CCR).

8. Federal Taxpayer Identification Number (TIN). In those exceptional cases where a contractor does not have a DUNS number or TIN, a Vendor Identification Number (VIN) must be referenced on the invoice. The VIN is the number that appears after the contractor’s name on the face page of the award document.

9. Identify that payment is to be made using a three-way match.

10. Description of supplies/services that match the description on the award, by line billed.*

11. Freight or delivery charge must be billed as shown on the award. If it is included in the item price do not bill it separately. If identified in the award as a separate line item, it must be billed separately.

12. Quantity, Unit of Measure, Unit Price, Extended Price of supplies delivered or services performed, as applicable, and that match the line items specified in the award.*

* NOTE: If your invoice must differ from the line items on the award, please contact the Contracting Officer before submitting the invoice. A modification to the order or contract may be needed before the invoice can be submitted and paid.

B. Shipping costs will be reimbursed only if authorized by the Contract/Purchase Order. If authorized, shipping costs must be itemized. Where shipping costs exceed $100, the invoice must be supported by a bill of lading or a paid carrier's receipt.

C. Mail an original and 1 copy of the itemized invoice to:

National Institutes of Health Office of Financial Management, Commercial Accounts 2115 East Jefferson Street, Room 4B-432, MSC 8500 Bethesda, MD 20892-8500

For inquiries regarding payment call: (301) 496-6088

In order to facilitate the prompt payment of invoices, it is recommended that the vendor submit a photocopy of the invoice to the “Consignee” designated for the acquisition in blocks 6A – 6E of the face page of the Order/Award document.

II. INVOICE PAYMENT

A. Except as indicated in paragraph B., below, the due date for making invoice payments by the designated payment office shall be the later of the following two events:

1. The 30th day after the designated billing office has received a proper invoice.

2. The 30th day after Government acceptance of supplies delivered or services performed.

B. The due date for making invoice payments for meat and meat food products, perishable agricultural commodities, dairy products, and edible fats or oils, shall be in accordance with the Prompt Payment Act, as amended.

III. INTEREST PENALTIES

A. An interest penalty shall be paid automatically, if payment is not made by the due date and the conditions listed below are met, if applicable.

1. A proper invoice was received by the designated billing office.

2. A receiving report or other Government documentation authorizing payment was processed and there was no disagreement over quantity, quality, or contractor compliance with a term or condition.

3. In the case of a final invoice for any balance of funds due the contractor for supplies delivered or services performed, the amount was not subject to further settlement actions between the Government and the Contractor.

B. Determination of interest and penalties due will be made in accordance with the provisions of the Prompt Payment Act, as amended, the Contract Disputes Act, and regulations issued by the Office of Management and Budget.

IV. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

SUBCONTRACTORS, FAR 52.232-40 (DEC 2013)

1. Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

1. The acceleration of payments under this clause does not provide any new rights under the prompt Payment Act.

Include the substance of this clause, include this paragraph c, in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.