CyTOF and O-Link Assessment in the NCI COVID-19 in Cancer Patients Study(NCCAPS)

The planned contract action is to extend the period of performance under authority FAR 6.302-1(a)(2)(ii) The Government intends to continue with one source, Icahn School of Medicine at Mount Sinai. Interested persons may identify their interest and capability to respond to the requirement. This notice of intent is not a request for competitive proposals. However, all proposals received will be considered by the Government. A determination by the Government not to continue with this planned contract action based upon responses to this notice is solely within the discretion of the Government. Background NCI awarded Contract Number 75N91021C00003 to Icahn School of Medicine at Mt Sinai as a cost-reimbursement contract with the period of performance from December 23, 2020 to December 22, 2021. This contract was modified to extend the period of performance through December 22, 2022. This contract provides expertise and experience to assess the cytokine and cellular compartments of the immune system in samples from cancer patients collected by the NCI COVID-19 in Cancer Patients Study (NCCAPS) study. The contractor employs O-link and CyTOF technologies, respectively, to accomplish this goal and provides the data to the NCCAPS study team using a data collection system under development by the NCI. In addition, this contractor works with NCI personnel, NCCAPS Biorepository staff, NCCAPS database Contractors and NCCAPS collaborating scientists, with the goal of reviewing biospecimen collections, updating the NCI on the assay results, and ensuring open and ongoing communication amongst all the stakeholders in this project. This contractor has worked with the NCI and the NCCAPS Biorepository to develop processes to receive de-identified plasma and white blood cell specimens from the NCI contracted biorepository for this study with careful documentation of biospecimen tracking within the laboratories to allow later re-linking to clinical data within the NCI database. In addition, the contractor has participated in meetings with NCI focused on data entry priorities, data cleaning, definition of variables and discussion on which analyses will be performed.. Description The National Cancer Institute (NCI) is seeking to extend the period of performance of the Contract Number 75N9121C00003, Titled: - CyTOF and O-link Assessment of Immune Response to COVID-19 in Cancer Patients (NCCAPS) which supports NCI in the study of the immune response to COVID-19 in patients with cancer by assessing the cellular compartment of the immune system using mass cytometry by CyTOF and cytokines by O-link profiling. The successful completion of the contract involves providing the expertise and experience of the contractor's laboratory to assess the cytokine and cellular compartments of the immune system in samples from up to 500 cancer patients collected by the NCCAPS study through O-link and CyTOF assays. In order to allow sufficient time to assay samples collected from cancer patients, the period of performance will need to be extended beyond its current 24 months under current contract 75N91021C00003. NCI intends to modify contract number 75N91021C00003, with Icahn School of Medicine at Mount Sinai to extend the period of performance by an additional 12 months to allow for completion of the study of the immune response to COVID-19 in patients with cancer by assessing the cellular compartment of the immune system using mass cytometry by CyTOF and cytokines by O-link profiling. NCI Intends to use the Statutory authority: 41 U.S.C. 253(c)(1), as set forth in FAR 6.302-1, only one responsible source and no other supplies or services will satisfy agency requirements. Icahn School of Medicine at Mount Sinai is the only responsible source, and no other supplies or services will satisfy agency requirements. Icahn School of Medicine at Mount Sinai has the unique capabilities as the only source to provide the services that meet NCI's needs. The CyTOF and O-link Assessment of Immune Response to COVID-19 in Cancer Patients (NCCAPS) as well as the assessing of the cellular compartment of the immune system using mass cytometry by CyTOF and cytokines by O-link profiling are all ongoing activities. The current investigators are acknowledged experts and national leaders in the field of assay development and validation and have extensive experience in performing cancer clinical trials where human biospecimens are collected and analyzed using these techniques. Their expertise also includes participation in scientific validation of the sought biomarker assays through prior work with the NCI. In addition, the investigators are involved in other NIH directed studies of COVID-19 where these assays are used. Icahn School of Medicine at Mount Sinai has the assay infrastructure necessary to perform requirements in stated above. Its infrastructure included development of quality control, assay precision and accuracy, as well as receipt of specimens from clinical trials and specimen flow from the biobank to the laboratory. Numerous CyTOF and O-link assays have been completed by the contractor and, the contractor is working on writing up the first scientific paper and a detailed paper is expected to follow. No other source has been found that possess all the necessary elements to perform the services in a way that would satisfy the requirements. Award to any other source would result in substantial duplication of cost to the Government that is not expected to be recovered through competition. This is not a request for proposals, Proposal abstracts, or quotations and does not commit the Government to any contractual agreement. The original award notice was posted to beta.sam.gov as Notice ID: 75N91021C00003. All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency. Interested parties may contact the points of contact referenced in this posting.