MODIFICATION
A -- Market research to assess the commercial availability or technical maturity of technologies that are capable of satisfying the capability gap for rapid diagnosis of infectious diseases (ID) in austere environments
- Notice Date
- 5/10/2013
- Notice Type
- Modification/Amendment
- 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
- W81XWH13RFIID
- Archive Date
- 8/8/2013
- Point of Contact
- Shannyn Scassero, 301-619-2640
- E-Mail Address
-
US Army Medical Research Acquisition Activity
(shannyn.scassero.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- THIS IS NOT A REQUEST FOR PROPOSAL (RFP) OR A REQUEST FOR QUOTATION (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 U.S. Army Medical Research and Materiel Command (USAMRMC) is conducting market research to assess the commercial availability or technical maturity of technologies that are capable of satisfying the capability gap for rapid diagnosis of infectious diseases (ID) in austere environments. Moreover, the USAMRMC wishes to receive industry comment on both the commercial interest and the commercial viability of diagnostic devices capable of meeting our needs, inclusive of affordability given the projected Department of Defense (DoD) demand. Attachment 1 describes the USAMRMC Target Product Profile (TPP) for ID diagnostic capabilities. Of note is the Key Performance Parameter (KPP) of US Food and Drug Administration (FDA) clearance. Commensurate with this parameter, respondents should strongly consider associated development cost, post FDA-clearance costs, and overall commercial viability both globally and in the US market in order to determine if candidate products can be sustained in a way that is both profitable to the company and affordable by the DoD. 3.0 Background: In the absence of approved prophylactic drugs and vaccines, prevention and early diagnosis remain the best option to mitigate the impact of certain ID pathogens in US Service Members. The USAMRMC has a need to develop and field (in a sustainable and affordable manner) forward-deployable, rapid, ID diagnostics that meet or exceed the specifications listed in Attachment 1 (see ATTACHMENT). Recently, the USAMRMC prioritized diseases and pathogens of interest for rapid diagnostic devices (see Table 1 in ATTACHMENT). This table, although not comprehensive, lists those IDs for which diagnostics are needed based on military end-user desirability and potential impact. Additionally, Table 1 lists the anticipated DoD annual purchase quantities. Note: Table 1 depicts the diseases and pathogens that are the USAMRMC's top priorities. However, the USAMRMC also has interest in developing other ID diagnostic capabilities that are not included in the table. Procurement quantities are subject to change and industry should comment on the feasibility of sustaining the capability on the US market given the procurement quantity listed. Prior to determining the acquisition strategy, the USAMRMC must assess the commercial market for availability and maturity of commercially developed ID diagnostic candidates that are both rapid and forward-deployable (henceforth referred to as quote mark candidates quote mark ) and gauge industry interest in developing these candidates for the US market. Moreover, the USAMRMC must ensure that a sufficient US market and industry interest (in that market) exists to warrant investment in development and (more importantly) sustainment of these candidates (following FDA-clearance) at quantities and cost that are sustainable in the marketplace and affordable to the USAMRMC. Specifically, the USAMRMC is interested in determining the following: A. candidate diagnostic products, either in the development pipeline or currently marketed in the US or in foreign markets, that can be used to diagnose the USAMRMC ID Pathogen Priorities shown in Table 1. B. the current status of each candidate C. how specifications of each candidate compare with the USAMRMC threshold/objective specifications (Attachment 1 in Attachment) D. why or why not pursuit of FDA clearance and the US marketing is or is not being currently considered E. the support interested industry sources will require from the DoD (technical and scientific expertise, clinical sites, research and development financial support, procurement needs (projected US market cost, projected sustainment quantity), etc.) In addition, the USAMRMC wishes to obtain industry feedback on strategies by which candidate assays can be combined, kitted, or otherwise optimized such that logistical burden can be minimized and greater affordability can be achieved in the long term. For example: Creatively packaging individual assay capabilities together may promote cost savings and affordability. Please share perspectives on different strategies that the MRMC may want to consider. Table 1: See Attachment for Table 1 Ultimately, in order for the USAMRMC to be able to field a candidate, it must meet or exceed the specifications listed in Attachement 1: FDA-cleared, no greater than moderate complexity, usable in austere environments (without the requirement for electricity or for ancillary laboratory equipment not provided with the diagnostic test), relatively small and lightweight, fielded with external controls, and provide results rapidly. Please refer to Attachment 1 for a complete list of specifications. It is preferred that the candidates 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 and affordability, the USAMRMC is also interested in several non-technical issues and strategic concerns. Ultimately, the USAMRMC wishes to obtain industry feedback in order to assess the viability and affordability of developing and maintaining a supply of ID diagnostic capabilities that meet specifications. Respondents should address these items as explained in Section 4.0. 4.0 Response Instructions: Respondents should address the following in their submission: A. Name and address of company B. Names and contact information of key company personnel Note: For items a through l, please focus on those candidates that correspond with ID pathogen priorities listed in Table 1and provide responses for each candidate proposed. C. Description of each ID diagnostic candidate currently in development that is (or will be) capable of meeting or exceeding the specifications in Attachment 1 to include: a. Name of proposed candidate(s) b. Intended use or proposed intended use c. Technical Description: A brief technical description explaining the technology utilized and manufacturing methods used and anticipated (or proven) sensitivity and specificity. Please also include information about the ability of the technology to multiplex (e.g. detect both pathogen Ag and human Ig; as applicable). d. Description of Packaging/Kit: Either current or proposed e. Ancillary Equipment/Consumables: Description of any equipment and consumables required to utilize the assay kit; indicating if each item is included with the kit (or not). f. Package Insert (if available) g. Candidate 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 for achieving FDA clearance. h. Projected selling price range per assay (please specify ranges for both US and foreign markets). It will be assumed that the US market price range will reflect the selling price to the DoD. Costs for the US market should be inclusive of external controls. i. Projected US and foreign market sales j. Projected annual US market sales volume (# of assays) needed to sustain the assay in the US market, at the price range described in item h. k. Minimum batch/production run size (# of assays / batch) l. Willingness to pursue FDA clearance and the US market D. Narrative: Please describe the barriers to market entry as you see them and any suggestions on how the DoD can help to make rapid diagnostic development more sustainable. To that end, explain and/or answer the following: a. Willingness/interest in co-developing ID diagnostic candidates with the DoD b. General capabilities and limitations of your company that may require assistance from the USAMRMC c. Willingness and ability to serve as the regulatory sponsor (510(k) holder) d. Description/explanation of availability and/or development of external positive controls, which is a requirement for fielding within the military. e. Feasibility of and willingness to pursue CLIA-waived status (in general) of candidates that have the potential to meet Attachment 1 specifications. Comment on whether CLIA-waived devices are within your strategic plans. Why or why not? f. Please comment on the overall market and sales with emphasis on US market and sustaining that market. Include commentary on continuing to market such candidates in the US both with and without DOD demand. Specifically, is the capability sustainable in the US market at the DoD demand levels depicted in Table 1? If not, what is a more realistic DoD demand that the USAMRMC should consider? g. Please describe (in general) any concerns you may have involving the sustainability of ID diagnostic products that meet or exceed USAMRMC specifications given the size of both US and foreign markets, and your anticipated profit margins. Expand on issues that you think the USAMRMC should consider in further considering development and acquisition strategy in terms of the potential to decrease unit cost and achieve better overall sustainability. h. Please describe any developmental or commercial partnerships and/or relationships that would facilitate development and fielding/supply to the US market. 5.0 CONTACT INFORMATION: Any and all questions related to this RFI shall be directed to Shannyn Scassero at shannyn.scassero.civ@mail.mil no later than 20 MAY 13, 12:00 PM ET. Response to all questions will be posted on FEDBIZOPPS as a modification to this RFI. All information regarding Capabilities Statements or any other proprietary information relative to this RFI shall be submitted via email to shannyn.scassero.civ@mail.mil no later than 12:00 PM ET on 10 JUN 13. NOTE: PLEASE TAKE NOTE OF RFI QUESTION CLOSING DATE (20 MAY 13) AS STATED ABOVE.
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