NICHD-20-232 – Sources Sought – Analysis of genetic variants associated with persistence of hepatitis B virus among Alaska Natives

Aug 12, 2020 | Sources Sought

SOURCES SOUGHT NOTICE
(Analysis of genetic variants associated with persistence of hepatitis B virus among Alaska Natives)
AGENCY:  The National Institutes of Health, National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK)

TITLE: Analysis of genetic variants associated with persistence of hepatitis B virus among Alaska Natives
PROPOSED SOLICITATION NUMBER: NICHD-20-232
PROJECT SERVICE CODE: Q301 – MEDICAL- LABORATORY TESTING

This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. There is no solicitation available at this time.

The purpose of this notice is to obtain information regarding: (1) the availability and capability of all qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification according to the North American Industry Classification System, (NAICS) code for the proposed acquisition. Your responses 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.

BACKGROUND:
Despite the availability of an effective vaccine, chronic hepatitis B (CHB) remains a substantial public health problem with health disparities. Globally, there are an estimated 257 million persons with chronic hepatitis B virus (HBV) infection accounting for over 887,000 deaths annually primarily from complications of cirrhosis and hepatocellular carcinoma (HCC). Indeed, chronic HBV and hepatitis C virus infections now rank as the leading infectious cause of death worldwide surpassing malaria, tuberculosis and cholera. Within the U.S., Asian Americans and Alaskan Natives are disproportionately affected by CHB. There is currently no curative therapy for CHB due to the persistence of episomal DNA (covalently closed circular DNA) in the hepatocyte nucleus. 

The presence of hepatitis B surface antigen (HBsAg) in serum for a period or 6 months or longer is the defining feature of CHB. Clearance of HBsAg is associated with improvement in outcome (lower rates of cirrhosis, hepatocellular carcinoma and liver-related death) but is rarely achieved. Spontaneous- or treatment-related HBsAg loss occurs at a rate of 0.5-1% per year. HBsAg loss or functional cure is the endpoint of novel treatments in development for chronic hepatitis B. Therefore, it is critical to identify factors that influence the rate of HBsAg loss. Factors that have been shown to be associated with HBsAg loss include older age, male gender, non-Asian race and lower levels of HBsAg in serum. As a viral infection it is highly likely that host genetic variants can modify the course of the infection including its persistence. Indeed, genome wide association studies (GWASs) have identified single nucleotide polymorphisms (SNPs) at eleven loci linking genetic susceptibility to persistent HBV infection in populations of Asian ancestry (Chinese, Japanese and Korean). However, it is unknown whether the genetic differences identified in East Asian populations are relevant to other populations with CHB. A thorough assessment of candidate genetic markers between Asian and Alaskan Native populations, an ethnically homogenous population, would address this issue.

Among the U.S. population, the Alaskan Native population is at increased risk for complications of CHB and disproportionately affected by HCC. Our collaborator, Dr. Brian McMahon has prospectively followed a cohort of >1500 Alaskan Natives with CHB over 4 decades and carefully documented and recorded outcomes of the cohort including HBsAg loss. Approximately 250 subjects have spontaneously cleared HBsAg, the marker of disease resolution. A candidate gene analysis of Alaskan Natives with CHB will inform whether there is a genetic contribution to HBsAg loss among this population. Further comparisons will be conducted among East Asian and European populations with CHB to understand if there are racial differences in viral persistence. We will integrate clinical and virological data with the results of the genetic analysis to develop risk models to predict HBsAg loss. The overarching goals of the research are to improve understanding of the pathogenesis of CHB, improve risk stratification models for clearance of HBsAg, and ultimately a personalized management approach to improve health disparities which will translate to lower health care costs and improved patient outcomes of CHB.

This Sources Sought is for an organization or institution to provide the NIDDK with services to provide a comprehensive assessment of known genetic markers in this population.  The purchase of these services are necessary to maintain the high quality of our research.  

All qualified small businesses, whether they are small businesses; HUBZone small businesses; service-disabled, veteran owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; interested in submitting a corporate capability statement should demonstrate their capability to provide equipment that meets the characteristics below.

SALIENT / REQUIRED FEATURES AND SPECIFICATIONS:

Task Area 1 – The contractor will amend an existing protocol to allow for the collection of genetic material using saliva and whole blood samples from Alaska Natives with chronic hepatitis B and provide those samples to the Liver Diseases Branch (LDB) at NIDDK.
    
Task Area 2 – The contractor will generate a de-identified list of potential participants who are infected with hepatitis B who are consented to their long-term natural history study and provide accompanying demographic, laboratory and outcome data to NIDDK/LDB. The data will be in a common electronic format e.g. Excel spreadsheet Numbers.

Task Area 3 – NIDDK/LDB will utilize the clinical data to complement the data generated from the candidate gene analysis on the DNA samples provided by the contractor at a later date. Given the complexity of the analysis, the interpretation of the results of these analyses may not be straightforward. It is expected that a collaborator and the contractor will provide the expertise to aid in the interpretation, for example, by reviewing analytic plans, tables of results and drafts of manuscripts or other research reports. Our collaborator may also facilitate the comparison of results with those from other populations (e.g. East Asian and European) and suggest alternate analytic strategies.

SPECIAL INSTRUCTIONS:
This acquisition is being conducted under the authority of FAR Part 13.5 Simplified Acquisition Procedures.

The vendor will be evaluated on their quoted product meeting the specifications under section SALIENT / REQUIRED FEATURES AND SPECIFICATIONS.

If you or your firm/business has an interest and possess the required expertise we invite you to submit a corporate capability statement to assist the Government in determining in accordance with Federal Acquisition Regulation (FAR) 19.502-2(b) whether or not this procurement will be set-aside for any of the programs described above. The associated NAICS code is 541380, Testing Services, and the small business size standard is $16.50.  All respondents are requested to identify their firm’s size and type of business.

Interested firms responding to this Sources Sought Notice should adhere to the following:
(a) Provide a capability statement demonstrating relevant experience, skills and ability to fulfill the Government’s requirements for the above. The capability statement should contain sufficient detail for the Government to make an informed decision regarding your capabilities. The capability statement should not exceed 15 pages using a font size 10 or larger.

(b) Small business concerns that possess the capabilities necessary to undertake the efforts should submit complete documentation of their capabilities to the Contracting Officer. This capability statement should include: 1) the total number of employees, 2) the professional qualifications of scientists, medical experts, and technical personnel as they relate to the requirements, 3) a description of general and specific facilities and equipment available, including computer equipment and software, and 4) any other specific and relevant information that would improve the Government’s consideration and evaluation of the information presented.

Further, Past Performance documentation, which should include, but not be limited to, a minimum of two (2) contracts performed for either Government or commercial organizations shall be provided. References shall include for each contract: names, titles, contract number, total price or cost, telephone numbers of government Contracting Officer Representative and Contracting Officers.

(c) All capability statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via email) to the Point of Contact below in MS Word or Adobe Portable Document Format (PDF). The subject line must specify NICHD-20-232. Facsimile responses will not be accepted. Electronically submitted capability statements are due no later than 9:00 AM (Eastern Prevailing Time) seven (7) calendar days (including date of submission to https://beta.sam.gov) after posting of the Small Business Sources Sought Notice.

CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED

This notice is for information and planning purposes only and is not to be construed as a commitment by the Government, nor will the Government pay for information solicited.

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