SOURCES SOUGHT
A -- Evaluation of New HIV Testing Technologies in Clinical Settings with High HIV Incidence
- Notice Date
- 4/21/2014
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 2014-68641
- Archive Date
- 5/20/2014
- Point of Contact
- Kim H. Morris, Phone: 7704882621, Theresa Routh-Murphy, Phone: 7704882713
- E-Mail Address
-
ycy1@cdc.gov, tnr3@cdc.gov
(ycy1@cdc.gov, tnr3@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Sources Sought Notice. It is NOT a solicitation for proposals, proposal abstracts, quotations, or an invitation for bid. The sole intent of this Sources Sought Notice is to obtain information regarding the availability and capability of qualified business sources (both small and large) for procurement planning purposes. The Centers for Disease Control and Prevention (CDC), National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) has a potential requirement to better understand the performance of available HIV tests and to use this information to update future CDC guidance on new HIV testing technologies. The applicable NAICS code is 541712 with a size standard of 500 employees. An estimated 50,000 new HIV infections occur each year in the United States. Men who have sex with men (MSM) are estimated to have the highest incidence of new HIV infections. The first few weeks after HIV infection, referred to as the acute stage in this document, can be defined as the stage when HIV infection can be detected by testing for HIV virus directly, but there is no detectable HIV-specific antibody response. Although clinical sensitivity of tests for HIV antibodies appears to be improving, detection of HIV infection during the acute stage, by definition, requires the ability to detect virus directly rather than relying on detection of antibody. Molecular tests for HIV have traditionally been complicated and expensive to perform, and although a variety of strategies to utilize these tests in clinical settings have been proposed, they are still not widely used. Several new HIV tests have recently been approved by the US Food and Drug Administration (FDA) for use on unprocessed specimens (e.g. fingerstick whole blood and/or oral fluid) at the point-of-care (POC), or their approval is imminent. So that CDC can monitor and update HIV testing guidance that reflects newly available testing technology and characterizes the relative performance of available tests, an evaluation must be conducted to understand the differences in sensitivity of the newest HIV serologic tests using unprocessed specimens collected from infected individuals while they are in the acute stage of disease. In addition, there is a need to evaluate the diagnostic performance of nucleic acid (molecular) tests to allow CDC to determine the applicability of this technology for use in a variety of clinical and point-of-care. In order to maximize the yield of persons identified shortly after they have been infected while limiting overall project costs, the study will be conducted in three parts. The objectives of each part of the proposed project are: 1) To identify persons at high-risk for early infection. In Part 1, up to 50,000 persons presenting for an HIV test at study sites will be categorized as high or lower risk, based on information extracted from their medical records, or collected directly from participants through a short questionnaire. This behavioral screener which will be used on 50,000 participants seeking HIV testing will be used to identify no more than 10,000 highest risk clinic clients for selection for Part 2. 2) The objective of Part 2 is to evaluate the tests under study using fresh specimens collected from no more than 10,000 Part 2 participants, including a minimum of 600 HIV-infected participants and 50 participants with early infection. Part 2 of the study will involve collecting specimens for testing with the HIV testing technologies being evaluated. 3) The objective of Part 3 is to evaluate the seroconversion sensitivity of the new HIV tests through serial follow-up. Participants with discordant test results will undergo frequent follow-up testing to document either seroconversion on all tests being evaluated, two consecutive visits with negative test results on all tests (indicating reactive Part 2 tests were false-positive), or the completion of 70 days of follow-up. It is expected that at least 50 participants with early infection will complete Part 3 follow-up. It is anticipated that contracts to no more than six (6) clinical sites (individually) or one overall contract to subcontract to six (6) sites will be awarded. In order to assess the capabilities/experience, the Offeror must have proven capabilities in the areas listed below. These areas will be the core requirements for the contemplated contract. 1. Does your firm serve the patient population necessary to conduct the study? Numbers below are for individual clinics, if your firm is a large business intending to subcontract, please document both prior collaborations with such clinical sites and the total numbers of clients at sites with which you would be able to subcontract (totals for the entire project are included in parentheses). a. At least 2000 unduplicated patients presenting at clinic for HIV testing in the most current 12-month period preceding submission of your response (12,000/year for the total project). b. A minimum of 2% undiagnosed HIV prevalence (number of new HIV diagnoses/number tested) over the prior 24 months preceding submission of your response. (2% overall at all clinical sites included in the project, and with no individual site included with less than 2% prevalence of undiagnosed infection in the prior 24 months). With 2000 unduplicated patients and a 2% prevalence, a total of 40 newly diagnosed patients per year are expected. If your firm collects information on client's risk, and would meet the minimum of 40 new infections identified in a subset of 2000 or less high-risk clients this should be stated in your response. If this is the case, please describe the criteria used to subset the population to this highest risk group, and document the yield of 40 newly diagnosed infections in no more than 2000 unduplicated individual clients in this high-risk subset using data collected in the 24 months prior to your response. c. A minimum of 0.2% acute stage HIV infection (defined as the presence of detectable HIV virus in the absence of detectable HIV antibody) among those tested for HIV over the prior 24 months preceding submission of your response. (0.2% prevalence of detected acute infection in the prior 24 months at every site included as a subcontract). With 2000 unduplicated patients and a 0.2% prevalence of acute infection, a total of 4 newly diagnosed, acutely infected patients per year are expected. If your firm collects information on client's risk, and would meet the minimum of 4 new infections identified in the acute stage from a subset of 2000 or less high-risk clients, this should be stated in your response. If this is the case, please describe the criteria used to subset the population to this highest risk group, and document the yield of 4 newly diagnosed acute infections in no more than 2000 unduplicated individual clients in this high-risk subset using data collected in the 24 months prior to your response. 2. Does your firm have an onsite laboratory to conduct an evaluation of novel HIV diagnostic tests? Describe the clinic laboratory and services for HIV testing. Provide a description of onsite laboratory capacity, including any testing currently performed on site, laboratory space available for testing onsite, and onsite equipment such as number of centrifuges, freezers for storing specimens, etc. If any HIV testing is currently performed offsite, please also describe the facilities where this testing is performed or would be performed, and the processes for sending specimens out for testing and turn-around time for receipt of the results of this testing. 3. Does your firm have prior experience conducting clinical evaluations of diagnostic tests within your patient population? Describe current and recent laboratory research, and capacity to conduct a variety of investigational tests on unprocessed specimens at the same time and prior experience with clinical evaluations of such tests, including any experience with protocols for submission of test performance data to FDA. Also describe current and recent experience collecting, cataloguing and storing biologic specimens for future testing. 4. Does your firm have experience developing, implementing and managing electronic databases of patient information? Examples of the types of data to be provided include: patient demographics (race, gender, age), prior testing history (ever tested, last test time (categorized as >3 years ago, 1-3 years ago, or months ago if tested in the past 12 months), and for those tested in the past 12 months (number of tests in that time period), prior HIV diagnosis, exposure to HIV pre-exposure prophylaxis in the past 3 months, and risk-behavior data, as well as all test results generated from patient specimens as part of the project. Describe prior experience collecting and managing such information. 5. Federal government contractors must comply with strict federal and agency standards, laws and regulations for security. Detail your firms experience complying with Section 508 of the Rehabilitation Act of 1973, the Federal Information Security Management Act (FISMA), and the Certification and Accreditation (C&A) process required by the EGovernment Act of 2002. Teaming Arrangements: All teaming arrangements shall include the above-cited information and certifications for each entity on the proposed team. Teaming arrangements are encouraged. Responses shall be limited to 15 pages, less than 10 is preferred, excluding the business information, single space, minimum Font Size 10, Times New Roman or Arial. Responses must be submitted via email no later than May 5, 2014, 4:00PM EST to Kim Morris at ycy1@cdc.gov. TELEPHONE CALLS WILL NOT BE ACCEPTED. Please provide the following Business information: 1. DUNS Number 2. Company Name 3. Company Address 4. Company Point of Contact, phone number and email address. 5. Type of company under NAICS, as validated via the System for Award Management (SAM). Additional information on NAICS codes can be found at www.sba.gov. Any potential government contract must be registered on the SAM located at http://www.sam.gov. 6. Corporate structure (corporation, LLC, sole proprietorship, partnership, limited liability partnership, professional corporation, etc.) 7. Current GSA Schedule contracts appropriate to this Sources Sought. 8. Current Government Wide Agency Contracts (GWACs). 9. Point of Contact, phone number and email address of individuals who can verify the demonstrated capabilities in the responses. 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 information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed. Information provided will be used to assess tradeoffs and alternatives available for the potential requirement and may lead to the development of a solicitation. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. Any solicitation resulting from the analysis of information obtained will be announced to the public in Federal Business Opportunities in accordance with the FAR Part 5. 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(s).
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