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National Cancer Institute (NCI), Center for Cancer Research (CCR), Radiation Oncology Branch (ROB) plans to procure, on a sole source basis, laboratory testing from SomaLogic, Inc. of 2945 Wilderness Place, Boulder, CO 80301.

This acquisition will be processed under FAR Part 12 – Acquisition for Commercial Items and will be made pursuant to the authority in FAR 13.106-1 (b)(1)(i) using simplified acquisition procedures for commercial acquisitions. The North American Industry Classification System code is 541990 and the business size standard is $15.0M.

BACKGROUND

The Radiation Oncology Branch (ROB) at the National Cancer Institute’s (NCI’s) Center for Cancer Research (CCR) designs and conducts pre-clinical and clinical research on the biologic and therapeutic effect of radiation therapy. The laboratory has characterized novel radiation responsive proteins and correlated their patterns of expression with absorbed dose in models of both total body and partial body exposure.

Since 2020, the laboratory utilizes SomaScan (SomaLogic, Inc.) assays which allow the simultaneous analysis of a high number of protein analytes from a single 130 ul volume sample. Glioblastoma (GBM) is the most common form of primary brain tumor found in adults in the United States. The current standard of care includes surgical resection, a concurrent course of radiation therapy (RT) and temozolomide (TMZ) treatment, followed by adjuvant TMZ administration with a median survival of 14.6 months. However, even with this extremely poor prognosis, there is a small subset of patients that lives 5 years (10-15%). Thus, attempts to develop screening tools with prognostic value for the identification of those patients with better outcomes have been undertaken. Though no validated circulating biomarkers for GBM have been integrated into clinical practice, the use of circulating biomarkers for management of GBM remains an attractive approach due to accessibility, the ability to take serial samples and lower costs. Emerging circulating biomarkers for GBM have been identified in blood, urine and cerebrospinal fluid. Development of prognostic biomarkers in easily accessible serum samples have the potential to improve the outcomes of patients with GBM through personalized therapy planning.

OBJECTIVE

The primary objective is to expand and conclude on previous studies using the latest SomaScan Discovery 7K Analyte assay (version v4.1) to obtain a large-scale proteomic biomarker screening of serum from clinical samples from patients with glioblastoma multiforme undergoing radiation therapy. The data derived from this screening will be used to identify novel radiation responsive proteins and to support further research to develop new clinical biomarkers with predictive, prognostic or diagnostic value.

SCOPE

The scope of the work to be performed is limited to a single screening of proteomic biomarkers in 58 human serum samples submitted to SomaLogic, Inc. for application on their SomaScan assay platform. The work shall include sample processing, running of the assay which analyzes over 7,000 proteins, and final data analysis. Data analysis shall include internal standardization and normalization, and preparation of the final report.

CONTRACT REQUIREMENTS

TASK 1: PROCESS EACH SAMPLE RECEIVED

Upon receipt of all 58 samples from the Government, the Contractor shall verify each sample label and the overall inventory of samples. The Contractor shall also aliquot from primary samples and any necessary dilutions for application on the assay platform.

Note: In the event residual samples remain after final data delivery, these residuals shall be returned to the Government within 1 month following the completion of analysis on dry ice.

TASK 2: RUN ASSAY ANALYSIS

The Contractor’s assay analysis shall include a single analysis per sample of 7,000 protein analytes conducted on samples of at least 130 µL, using their proprietary SomaScan 7K assay. The analysis shall quantify proteins that span no less than 8 logs in abundance (from femtomolar to micromolar), with reproducibility of 4.6 median % CV (co-efficient of variation). The Contractor shall measure native proteins in complex matrices by transforming each individual protein concentration into a corresponding reagent concentration, which shall then be quantified by standard DNA techniques (microarrays or qPCR). The Contractor’s analysis shall include SOMASignal RUO (research use only) Tests to measure quality control factors, including (i) time from collection to freeze, (ii) number of freeze-thaw cycles, (iii) sample handling, (iv) time from collection to centrifugation, and (v) time from collection to supernatant decantation after centrifugation.

TASK 3: DELIVER FINAL DATA AND ANALYSIS REPORT

The Contractor shall deliver a final report inclusive of all data points for all samples which include analysis data normalized against intra assay controls, and secondary normalization to interpolate control standards. Data shall be supplied for all submitted samples in the form of Relative Fluorescent Units (RFU) for all aptamers present in the assay. The report shall be provided in SomaLogic specific .ADAT file format.

Note: All data generated shall be the sole property of the U.S. Government.

GOVERNMENT RESPONSIBILITIES

The Government Technical Point of Contact (TPOC) will coordinate with the Contractor to deliver samples to the Contractor’s facilities. Samples will be shipped no later than 45 calendar days after award. The Government will be responsible for arranging shipment of samples to and from the Contractor.

TYPE OF ORDER

This is a firm fixed price purchase order for non-severable services.

PERIOD OF PERFORMANCE

The period of performance shall be for 6 months from 08/01/2023 to 01/31/2024.

PLACE OF PERFORMANCE

Work shall be performed at the Contractor’s facilities.

TECHNICAL POINT OF CONTACT

The Technical Point of Contact (TPOC) will serve as the Governments point of contact for coordination of all required efforts covered under the scope of the purchase order. Additionally, all services shall be delivered to the TPOC for final inspection and acceptance upon completion.

All deliverables will have been deemed accepted fifteen (15) calendar days after date of delivery, except as otherwise specified in this purchase order if written approval or disapproval has not been given within such period.

REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE

The below table outlines the deliverables which the Contractor is responsible for fulfilling throughout the requirement. All submittals shall be submitted electronically to the TPOC and individuals identified below for inspection and acceptance.

Deliverable

Description

Due Date

Task #1

(see Section 4.1)

Email confirmation of receipt of samples

Immediately upon receipt of delivery

Task #2

(see Section 4.2)

Performance of SomaScan Discovery 7K Analyte assays and SOMASignal RUO tests

No later than 14 calendar days after receipt of delivery

Task #3

(see Section 4.3)

Delivery of final data and analysis report (final report)

No later than 30 calendar days after receipt of delivery

All deliverables shall be sent electronically as Microsoft Excel, or Adobe Portable Document Format (PDF), or SomaLogic-specific .ADAT file format unless otherwise approved by the TPOC.

Electronic copies of the final report shall be provided within 30 days following submission of biological samples. The report shall be sent electronically to the TPOC.

The Radiation Oncology Branch at CCR requires commercial proteomic analysis services, utilizing the 7K SomaScan platform V4.1 from SomaLogic, Inc., for the identification of radiation biomarkers fromapproximately 58 human serum samples.

This is a follow-on requirement with the purpose of expanding and concluding previous studies on murine and human radiation exposure biomarkers using the SomaScan assay provided by SomaLogic, Inc. Funding for this study is specifically limited to the SomaScan platform. Furthermore, the purchase of these services from the same vendor will ensure the generation of scientifically comparable data.

The National Cancer Institute (NCI), Center for Cancer Research (CCR), Radiation Oncology Branch (ROB) has characterized novel radiation-responsive proteins and correlated their patterns of expression with absorbed dose in models of both total body and partial body exposure. Their most recent work using the Somalogic Inc. SomaScan 1.3K Analyte assay, which uses a proprietary aptamer-based approach to simultaneously screen 1,310 analytes, yielded novel panels of significantly altered proteomic biomarkers of radiation exposure. ROB’s collective studies have consistently shown that higher predictive accuracies for radiation exposure and level of dose prediction are achieved when multiple biomarkers are used, and the benefit of taking advantage of highly multiplexed proteomic expression analysis technologies.

The primary objective of this project is to expand on ROB’s previous studies by using the latest Somalogic, Inc. SomaScan 7K assay to obtain a large scale proteomic biomarker screening of serum from clinical samples from patients with glioblastoma multiforme undergoing radiation therapy. In the current project an additional expanded clinical cohort will be run to augment data/findings from previous studies. ROB will use the data derived from this screening to identify novel radiation responsive proteins and to support further research to develop new clinical biomarkers with predictive, prognostic or diagnostic value.

SomaScan is a high-throughput, aptamer-based proteomics assay designed for the simultaneous measurement of thousands of proteins with a broad range of endogenous concentrations. The SomaScan platform is enabled by a new generation of protein-capture SOMAmer (Slow Off-rate Modified Aptamer) reagents which are constructed with chemically modified nucleotides that greatly expand the physicochemical diversity of the large randomized nucleic acid libraries from which the SOMAmer reagents are selected. The SomaScan platform measures native proteins in complex matrices by transforming each individual protein concentration into a corresponding SOMAmer reagent concentration, which is then quantified by standard DNA techniques such as microarrays or qPCR.

The most current assay version, 7K SomaScan V4.1, measures ~7,000 protein analytes in only 130 ìL of serum, plasma or cerebrospinal fluid, or equally small amounts of a variety of other biological matrices. The assay offers an exceptional dynamic range, quantifying proteins that span over 8 logs in abundance (from femtomolar to micromolar), with excellent reproducibility (4.6 median %CV).

NCI’s ROB has previously utilized SomaLogic Inc’s 7K SomaScan V4.1 in support of ongoing research involving proteomic analyses for the identification of radiation biomarkers in small-volume samples from murine and human plasma. The current study is a continuation of previous efforts performed by SomaLogic Inc in their lab, utilizing their SomaScan V.4.1 platform and experimental protocols and data normalization processes. As such SomaLogic is the only vendor able to maintain scientific comparability of the previously generated data related to ROB’s ongoing research. Therefore, SomaLogic is the only vendor with the required technical capabilities needed to maintain scientifically comparable results with related past efforts and studies utilizing 7K SomaScan V4.1. Inconsistency in resulting data would lead to unacceptable delays and substantial duplication of cost to the NCI, not expected to be recovered through competition.

This notice is not a request for competitive quotation. However, if any interested party, especially small business believes it can meet the above requirement, it may submit a capability statement 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. Responses must be received in the contracting office by 12:00 PM ET, on May 26, 2023. All responses and questions must be via email to Miguel Diaz, Contracting Officer at miguel.diaz@nih.gov. 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 the System for Award Management, SAM.gov, and have their Representations and Certifications completed.

Reference: 75N91023Q6660334 on all correspondence.

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