NOI_75N91023Q00153.pdf

NOTICE OF INTENT (NOI)

NCI NOI No.: 75N91023Q00153

Title: Acquisition of one (1) OLINK Signature Q100 instrument and accessories Notice ID Number: 75N91023Q00153 Response Date: 8/9/23 (3:00 pm EST) PSC Code: 6640 - Laboratory Equipment and Supplies NAICS Code: 334516 – Analytical Laboratory Instrument Manufacturing

1.0 DESCRIPTION

The Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Office of Acquisitions (OA) intends to procure, on a sole source basis, one (1) OLINK Signature Q100 instrument and accessories from Olink Proteomics Inc., 130 Turner Street, Waltham, Massachusetts 02453-8901.

The publicizing and response time of the notice for this requirement is in accordance with Federal Acquisition Regulation (FAR) 5.203. This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR Part 13.106-1(b)(1); and is exempt from the requirements of FAR Part 6. The North American Industry Classification System (NAICS) code is 334516 – Analytical Laboratory Instrument Manufacturing and the business size standard is 1,000 employees.

2.0 BACKGROUND

The U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), Center for Immuno-Oncology (CIO) functions as a multidisciplinary and interdisciplinary translational research programmatic effort with the goal of developing novel immunotherapies for cancer. As part of its research effort, the CIO performs studies aimed at understanding of the complex interplay between components of the immune system and the tumor and tumor-associated stromal tissues. These observations help to develop immunotherapeutic treatment regimens capable of promoting an effective anti-tumor immune response.

The acquisition of the required instrument will allow researchers within the CIO to simultaneously measure 88 tumor-associated proteins present at the tumor site and circulating in blood using only 1 microliter of sample. This capability will allow investigators at the CIO to measure all these proteins in clinical samples and in preclinical studies, including biomarkers of treatment response, in real-time following treatment with various immunotherapeutic agents given the minimal sample amount required. These experimental procedures are an essential aspect of the CIO’s research program, which provides the pre-clinical rationale for the clinical trials performed by the CIO as well as the examination of the effects of experimental treatments in immune cells and other cell types from cancer patients enrolled in NCI clinical trials.

3.0 TYPE OF ORDER

This is a Firm Fixed-Price Purchase Order.

4.0 SPECIAL ORDER REQUIREMENTS

4.1 REQUIRED ITEMS

The following items shall be included:

Item Description Product No. Quantity 1 Olink Signature Q100 Instrument and interface plate format 96.96 for Target 96 kits 96000 1

2 Olink Signature Q100 Power cord US 96020 1 3 Olink Signature Q100 Interface Plate 48.48 for Target 48 and Flex kits 96011 1

4 Olink NPX Software Access 91050 1 5 Olink Target 48 Cytokine Reagent Kit 93200 1 6 Olink Pooled Plasma Training Sample 97007 1 7 Olink 48.48 IFC for Protein Expression Target 48 kit for training 93007 1

8 Olink 96.96 IFC for Protein Expression 95007 1 9 Olink Target/Flex/Focus Training Kit 91957 1

4.2 PRODUCT FEATURES/SALIENT CHARACTERISTICS

The following product features/characteristics are required for this acquisition:

1) Sample requirement: 1uL volume;

2) Internal controls for each sample at each step of the protocol;

3) No requirement for technical replicates;

4) Signal generation via dual genomic label with digital barcode to confirm correct binding;

5) Dual detection format where both antibodies carry label components (a digital barcode providing 2-step authentication);

6) No-wash format to preserve weak binders;

7) Ability to run non-validated sample types with universal sample diluent;

8) Ability to perform Proximity Extension Assay (PEA);

9) Ability to process Integrated Fluidic Chips with automated microfluidics;

10) Ability to generate a fluorescent signal via PCR thermal cycles;

11) Ability to discriminate proteins without biological cross-reactivity;

12) Ability to process up to 88 samples in one run;

13) Ability to create a unique protein signature via 92 unique tests simultaneously;

14) Ability to generate data as correlative normalized protein expression (NPX) as well as absolute quantification (pg/mL);

15) Small footprint to fit within 1.5 linear feet of bench space;

16) Instrument check with onboard diagnostics;

17) Self-calibration;

18) Ports for connectivity (HDMI, ethernet for DHCP networking, compressed air);

19) Network segmentation;

20) On-screen help and real-time monitor;

21) Ability to export run logs and data via USB; and

22) Permissions set as Manager or User

4.3 WARRANTY

The Contractor shall warrant all supplies furnished under this award against any defects in design, material, or manufacture for a period of at least twelve (12) months from the date of installation. The Contractor shall also warrant and imply that all items delivered as a result of this order are merchantable and fit for use for the particular purpose described in the order in accordance with FAR 52.212-4(o).

If a defect results in lost or decreased performance of supplies or services furnished under this order, the Contractor shall cover all parts, materials, labor, and/or travel expenses required to repair or replace the supplies at no cost to the Government. Supplies which are repaired or replaced shall be warranted for the remainder of the initial warranty period or for 90-days – whichever is greater.

4.4 DELIVERY / INSTALLATION

The Contractor shall deliver all required items within 45 business days of purchase order award.

The Contractor shall provide the NCI Technical Point of Contact (TPOC) with tracking information to anticipate delivery to the best extent possible. All shipping/handling (including FOB) and delivery/installation fees shall be included. Upon delivery, the Contractor shall notify the TPOC to schedule the installation date and time that shall occur within five (5) business days of delivery. Installation shall be performed by, or under the direct supervision of, an Original Equipment Manufacturer (OEM) authorized and certified operator. The instrument and accessories shall be delivered to and installed at the following location:

Clinical Support Laboratory (CSL) Applied/Developmental Research Directorate Frederick National Laboratory for Cancer Research 1050 Boyles St., Bldg. 469/ Rm. 145 Frederick, MD 21702

4.5 TRAINING / SUPPORT

The Contractor shall provide a minimum of one (1) in-person training session for one (1) end-user within six (6) weeks of equipment installation. Virtual training shall be conducted within five (5) business days of equipment installation. Training must be facilitated by OEM-authorized and certified personnel. Training shall include an overview of setup approaches, maintaining instrument settings, establishing operational parameters for custom instrument configurations, and a demonstration of the performance. The Contractor shall provide technical support and protocols for non-validated sample types and Tier-1 biostats support. All training and support expenses, including materials and/or travel expenses shall be included.

5.0 UNIQUE QUALIFICATIONS OF THE CONTRACTOR

The NCI’s Center for Immuno-Oncology (CIO) examines the effects of experimental treatments in murine immune cells and other cell types from cancer patients enrolled in NCI-sponsored clinical trials. For this purpose, CIO requires a protein analyzer that allows the efficient analysis of many tumor biomarkers from very small sample volumes.

Olink Proteomics Inc. is the manufacturer of the Olink Signature Q100 analyzer system and accessories. The Olink Signature Q100 analyzer is the only commercially available scientific instrument that simultaneously measures up to 96 proteins in less than 1 ul of sample in up to 96 samples at a time. The associated Olink protein panels cover the full range of human and murine tumor markers to be investigated by CIO. Olink’s protein panels are exclusive kits compatible with Olink’s Q Signature 100 device, and no other vendor currently sells specifically designed and validated assays or systems able to perform Olink's proprietary Proximity Extension Assay (PEA). Furthermore, the required instrument has been optimized for use with several reagents and consumables available for purchase from Olink Proteomics which will allow CIO to simultaneously monitor many proteins associated with response to cancer therapy in mice and in patients.

The CIO has been examining patient and preclinical samples using Olink Proteomics Proximity Extension Assay (PEA) assays for preclinical studies and ongoing clinical trials in order to gain a deeper understanding of the mode of action of various experimental therapies in cancer patients. These assays were performed by the Olink laboratory services, which is an option no longer offered by Olink. Thus, in order to continue utilizing the PEA assays, the CIO requires an Olink Signature 100 in-house to continue to perform further research utilizing Olink’s PEA assays. Having this capability will prevent research delays and/or duplicated research efforts and costs and ensure scientific comparability with previously generated data pertaining to experimental therapies for cancer patients in CIO clinical trials and preclinical studies.

6.0 RESPONSE INSTRUCTIONS

This notice is not a request for competitive quotations. However, if any interested party believes it can meet the above requirements, it may submit a proposal or quote for the Government to consider. The response and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. All responses must be sent via email to Contracting Officer, Megan Kisamore, at megan.kisamore@nih.gov by no later than 3:00 PM EST, on Wednesday, August 9, 2023 (8/9/23). A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government.

Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award, Contractors must be registered and have valid certification through SAM.gov. Reference: 75N91023Q00153 on all correspondence.