A Public Health Genomics Approach to Cancer Etiology and Risk Estimation

Type of Notice: This is a Small Businesses Sources Sought notice (SS). This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small business; HUBZone small businesses; service-disabled, veteran-owned small businesses, 8(a) small businesses; veteran-owned small businesses; women-owned small businesses; or small disadvantaged business; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your response to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. The NAICS code for this project is 541690. The small business size standard is $15M. Background: The Clinical Genetics Branch (CGB), National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics Branch (DCEG), has a need to access anonymized genomic data linked to longitudinal clinical data from clinical programs that have created platforms for genomic discovery, drug development and clinical genomic implementation. The traditional approach to evaluating a phenotype is subject to ascertainment bias towards the most highly-penetrant clinical manifestations. The availability of large-scale, population-based exome-sequenced cohorts linked to the electronic health record (EHR) will substantially change the traditional, rare-disease clinical genetics paradigm. The new model inverts the traditional "phenotype-first" strategy into a "genotype-first" strategy in which we start with a sequenced rare variant, characterize the variant distribution in a population embedded within an EHR resource, and then determine its associated phenotype in an individual. This "public health genomics" approach has the potential to reduce ascertainment bias, identify the complete phenotypic spectrum, provide a more comprehensive gauge of phenotype severity, and permit more precise gene/variant penetrance and risk estimates. This Small Business Sources Sought (SBSS) is for information and planning purposes only and shall not be construed as an obligation on the part of NCI. Purpose and Objectives: The goal of this acquisition is to acquire highly specific and detailed EHR data with matching exome sequence data that will allow the investigation of the genotype-first approach in a comprehensive way using numerous cancer-associated genes studied by DCEG investigators in established, funded protocols. Specifically, the scientific needs of this acquisition include EHR on a minimum of 25,000 individuals with matched exome sequence data that will allow: 1) Quantification of pathogenic germline variant prevalence and the spectrum of different variants; 2) Refinement of estimates of phenotype (especially cancer and cancer precursors) penetrance in carriers of pathogenic germline variation in genes of interest; 3) Detailed characterization of cancer phenotype (histology, location, natural history) associated with germline variants evaluated in 1 and 2; 4) Quantification of gene-specific cancer risk in individuals with and without family history; 5) Development of eligible gene- and disease-specific patient referrals for actively recruiting DCEG protocols. NCI is seeking capability statements from all eligible small businesses concerns in performing the tasks/duties herein. Based on the responses received from this SBSS notice, the proposed project may be solicited as a Small Business Set-Aside. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NCI shall arise as a result of a response to this Small Business Sources Sought notice or the NCI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. Project Requirements: A copy of the draft Statement of Work (SOW) pertaining to this requirement, which is subject to revisions, is attached to this notice. Anticipated Period of Performance: The anticipated period of performance, inclusive of options, for this proposed acquisition is November 2020 - November 2025. Multiple awards may be made from a single solicitation. Capability Statement/Information Sought: Small businesses possessing experience and demonstrated capability to accomplish the aforementioned requirements and level of effort are to supply pertinent information in sufficient detail to demonstrate their ability to perform the required services. Information furnished must not exceed 20 pages (12-point font minimum), including all attachments, resumes, charts, etc.; and should include an outline of previous or similar projects performed. All responses must include an indication of current certified small business status, and clearly marked on the first page of the capability statement, as well as the eligible small business concern's name, point of contact, address, and DUNS number. Information Submission Instructions: All capability statements sent in response to this Small Business Sources Sought notice must be sent electronically (via email) to Lisa Bielen, Contracting Officer at lisa.bielen@nih.gov and Jill Johnson, Contracting Officer at jill.johnson2@nih.gov in either MS Word or Adobe Portable Document Format (PDF) by November 12, 2019; 2:00PM Eastern. All responses must be received by the specified due date and time in order to be considered. Capability Statements received after that date and time will not be considered.