SOURCES SOUGHT
65 -- Dengue Diagnostic System
- Notice Date
- 10/10/2012
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH-12-S-N042
- Response Due
- 11/9/2012
- Archive Date
- 1/8/2013
- Point of Contact
- Michael Ursone, 301-619-9525
- E-Mail Address
-
US Army Medical Research Acquisition Activity
(michael.ursone@amedd.army.mil)
- Small Business Set-Aside
- N/A
- Description
- Subject: Dengue Diagnostic System Sources Sought THIS IS NOT A REQUEST FOR PROPOSALS (RFP) OR A REQUEST FOR QUOTATIONS (RFQ); IT IS STRICTLY A REQUEST FOR INFORMATION (RFI). NEITHER UNSOLICITED PROPOSALS NOR ANY OTHER KINDS OF OFFERS WILL BE CONSIDERED IN RESPONSE TO THIS RFI. NO CONTRACT WILL BE AWARDED PURSUANT TO THIS ANNOUNCEMENT. 1.0 DISCLAIMER: This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. All information received in response to this RFI that is marked Proprietary will be handled accordingly. Responses to the RFI will not be returned. At this time, questions concerning the composition and requirements for a future RFP will not be entertained. 2.0 SUBJECT: The Pharmaceutical Systems Project Management Office (PSPMO) of the U.S. Army Medical Material Development Activity (USAMMDA) is conducting market research to assess the maturity and commercial availability of products capable of satisfying the capability gap for diagnosis of dengue infection. In order to satisfy this capability gap, the PSPMO seeks to develop and field candidate products that meet or exceed the specifications provided in Attachment 1. Of note is the Key performance parameter (KPP) of US Food and Drug Administration (FDA) clearance. Commensurate with this goal, the PSPMO wishes to obtain information from commercial sources that possess candidate dengue diagnostic products capable of meeting (or have met) the KPP and that are capable of performing within or above the specifications provided in Attachment 1. Respondents should describe only those candidates that: Are capable of satisfying the specifications provided in Attachment 1 Are currently marketed or currently in development Have a minimum maturity level equal to (at least) demonstrated proof-of-concept in a well controlled bench performance study 3.0 Background: Dengue Fever infection is the second ranked infectious disease priority of the US Military. Development of a dengue diagnostic capability for use in a deployed setting is but one materiel solution being considered in the family of systems approach toward dengue infections. In the absence of approved drugs and vaccines, prevention and early diagnosis remain the best option to mitigate the impact of dengue infection in US troops. Toward this end, the PSPMO assessing the commercial market for candidate dengue diagnostic products capable of fulfilling the capability gap. At a minimum, dengue diagnostic system candidates must meet the threshold parameters shown in Attachment 1. Ideal candidates will meet or exceed the objective parameters listed in Attachment 1. At minimum, candidates must have demonstrated proof-of-concept in a well controlled bench performance study. A preferred candidate is FDA-cleared or is capable of achieving FDA clearance within 3-years. Candidate tests or technologies must be usable in an austere environment, preferably without the requirement for electricity or for ancillary laboratory equipment not provided with the diagnostic test. It is preferred that the candidate will be usable by medical personnel (such as a medic or physician assistant) without specialized medical laboratory technician training (i.e., the test is CLIA-waived or capable of being CLIA-waived). In addition to technical performance, the PSPMO is also interested in several non-technical characteristics. Respondents should address these items as explained in Section 4.0. 4.0 Response Instructions: Respondents should address the following in their submission: Name and address of company Names and contact information of key company personnel Description of proposed candidate(s), to include: oName of proposed candidate(s) oIntended Use or proposed intended use oTechnical Description: A thorough technical description explaining the technology utilized and manufacturing methods used. oDescription of Packaging/Kit: Either current or proposed. Please include a description of all contents of the assay kit oAncillary Equipment/Consumables: Description of any equipment and consumables required to utilize the assay kit. Describe all equipment/consumables needed that are not included with the kit oPackage Insert (if available) oCandidate Maturity: Please describe the clearance status of the candidate to include (as applicable) FDA-clearance status and/or any clearance/obtained marketing permits for use in foreign countries. If not yet FDA-cleared, please specify an estimated time frame required to achieve FDA clearance. Describe, as well, the testing performed and summary of results obtained throughout development of the candidate to include (but not limited to): bench performance, clinical performance, cross-reactivity, matrix equivalency, etc. Product Development Plan. This plan does not need to be highly detailed. However, the plan should depict major activities required to obtain FDA clearance and approximate timeframes (calendar year and quarter). Please include any required clinical performance studies, briefly describing (at minimum) the following: region/study site location, number of subjects, study groups. Also include a description of any bench performance studies, indicating laboratory site(s) that will be utilized. Please indicate if you are interested/need to utilize USAMRMC laboratory or clinical sites. Sustainability Plan. Briefly describe the market for your product (both in the Continental US and abroad) to include projected US and foreign sales. Please expand on the cost-effectiveness of achieving FDA licensure for your proposed candidate(s), indicating if and how the candidate will be profiAttachment and sustainable. Needs. In accordance with the provided development plan, respondents should provide information on their projected needs from the DoD; i.e., what they would expect the PSPMO to supply in terms of resources (by development plan activity, not the dollar amount), clinical sites, scientific expertise, materials, etc. in order to achieve the KPP of US FDA-clearance. Narrative. Explain the following: oWillingness and ability to serve as the regulatory sponsor (510(k) holder) for the candidate oWillingness/interest in co-developing dengue diagnostic candidates with the DoD oDescription of what may be provided to facilitate product development (by the respondent). Ex: Clinical site(s), scientific expertise, provision of product candidates in adequate supplies to support development, regulatory support, manufacturing, etc. oProjected US and foreign market oWillingness to achieve FDA clearance with proposed candidate(s) oDescription/explanation of availability and/or development of external positive controls, which will be required for fielding. oWillingness to pursue CLIA-waived status of the capability - provided that the clinical performance proves adequate to achieve CLIA-waived status, please comment on if your market analysis and supportability assessments provide adequate cost-benefit to pursuit of CLIA-waiver and if pursuit would be within your strategic plans. 5.0 CONTACT INFORMATION: Any and all questions related to this RFI shall be directed to Michael Ursone at 301-619-9525. All information regarding Capabilities Statements or any other proprietary information relative to this RFI shall be submitted via email to michael.ursone@amedd.army.mil, no later than 3:00 pm E.S.T. on 9 November 2012.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH-12-S-N042/listing.html)
- Place of Performance
- Address: US Army Medical Research Acquisition Activity ATTN: MCMR-AAA, 820 Chandler Street Frederick MD
- Zip Code: 21702-5014
- Zip Code: 21702-5014
- Record
- SN02911213-W 20121012/121010234119-a1a3b858e6c175506257e030e9689a78 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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