SB_Sources_Sought_Notice_(3-14-25)_1.docx

Title: 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 $19M.

Background:

This Sources Sought Notice supports ongoing research experiments.

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 research under the previous contract provides important public health information on the risk of common and rare cancers arising from cancer-predisposition genes using a new gene-focused approach. This research proposes to use genetic data on >150,000 adults and children combined with electronic health record (EHR) data to answer important public health questions for the American people including estimating cancer risk, determining prevalence of genetic disorders, and evaluating penetrance associated with specific genetic variants. Exomes capture genetic sequence variation from all ~20,000 genes.

In the traditional approach to estimate cancer risk, people with a cancer (say breast cancer) are sequenced. Using statistics, risk estimates are calculated so a person can be counseled on how likely a cancer would develop given the type of mutation they have. For some genes and cancers (like BRCA1 or BRCA2, which increase risks for breast cancer), these risk estimates are very high (60-70% chance of developing breast cancer in women over their lifetime). However, this traditional approach may over-estimate risk since only people who had developed cancer are sequenced; people with a mutation but who never developed a cancer were missed.

Using the proposed genetic and EHR data on >150,000 adults and children, we are investigating a new approach to quantify cancer risk by reversing the traditional approach. Instead of starting with people with cancer, we identify people in the study cohort with mutations in cancer genes and then ask what types of cancers developed. Findings under the previous contract have demonstrated that cancer gene mutations are more common in the population than expected and that the risk from those mutations is lower than expected. We have also observed significant differences in survival (usually improved) from those mutations compared to what has been previously reported. It is essential to further investigate these findings to provide better risk estimates to individuals who carry mutations in the genes under study and to follow-up to evaluate reasons for the differences in survival for mutation carriers. 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 support the study of rare disorders and 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. To support this, NCI needs a sample size sufficient to have power for the required evaluations. For example, based on a study with the prevalence of the genetic disorder being 1:1000 and a cancer rate of 1%, we would need to have a sample size of 100,000 to have 80% power to detect an odds ratio of 4.0. A sample size of 200,000 would have 80% power to detect an odds ratio of 3.0. Thus, a sample size of at least 150,000 would provide sufficient power for detecting likely odds ratios for individual cancer risks in rare disorders. Thus, NCI believes the scientific needs of this acquisition include EHR on a minimum of 150,000 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 February 2026 – February 2031.

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 UEI number.

Information Submission Instructions:

All capability statements sent in response to this Small Business Sources Sought notice must be sent electronically (via email) to Bryan Dankanich, Contracting Officer at bryan.dankanich@nih.gov and Kari Peterson, Contracting Officer/Team Lead at kari.peterson@nih.gov in either MS Word or Adobe Portable Document Format (PDF) by March 29, 2025; 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.

Disclaimer and Important Notes:

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use the information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in the System for Awards Management (SAM). However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality:

No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation.