SOURCES SOUGHT
A -- Influenza IVD Assays
- Notice Date
- 10/23/2009
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- US Army Space and Missile Defense Command, Deputy Commander, ATTN SMDC-CM-AP, P.O. Box 1500, Huntsville, AL 35807-3801
- ZIP Code
- 35807-3801
- Solicitation Number
- W9113M-10-R-0003
- Response Due
- 3/31/2010
- Archive Date
- 5/30/2010
- Point of Contact
- Cynthia Gnam, 301-619-8453
- E-Mail Address
-
US Army Space and Missile Defense Command, Deputy Commander
(cynthia.gnam@us.army.mil)
- Small Business Set-Aside
- N/A
- Description
- Influenza IVD Assays for JBAIDS Analyzer This is a Research and Development Sources Sought in accordance with FAR 5.205(a). Responses to this notice will not be considered an offer and cannot be accepted by the Government to form a binding contract. This announcement is not to be construed as a commitment by the Government, nor will the Government pay for the information solicited. The U.S. Army Joint Program Management Office (JPMO) for Chemical, Biological, and Medical Systems (CBMS) requests that any qualified interested parties respond with information regarding their capabilities in the development and production of influenza in vitro diagnostic (IVD) assays, specifically for use on the US Army Joint Biological Agent Identification and Diagnostic System (JBAIDS) (Block I). Description: The JPMO CBMS is seeking companies with experience and capability in developing IVD assays for the detection of influenza A, influenza B, and influenza A subtypes. Specifically, companies would develop and validate real-time reverse transcriptase polymerase chain reaction (rRT-PCR) assays to aid in clinical diagnosis using the existing Joint Biological Agent Identification and Diagnostic System (JBAIDS) analyzer, developed and manufactured by Idaho Technology, Inc. The panel of assays would be designed to identify clinical specimens that are positive for influenza A or B, followed by subtyping the influenza A hemagglutinin. This suite of assays would quickly and accurately identify and differentiate influenza A and B infections. This announcement pertains to specific influenza assays described herein; no other diseases or agents are included. Assay Development and Assessment would include the following: 1. Develop (if necessary), or obtain rights to designs of, the target assays that are able to identify the following influenza virus strains at levels comparable to assays already cleared by FDA, or at clinically relevant concentrations in the absence of a FDA-cleared predicate assay: a. Pan-Influenza Type A, b. Pan-Influenza Type B, c. Seasonal Influenza Type A/H1, d. Seasonal Influenza Type A/H3, e. Pan-Swine Influenza Type A, f. Swine Influenza Type A (H1 target - 2009 strain) 2. Develop (if necessary) synthetic positive template control materials for each assay that can be multiplexed with each of the corresponding target assay reagents; 3. Optimize the assays on the JBAIDS instrument; 4. Formulate the assays in a freeze-dried, room-temperature (18-28C) stable format consistent with the existing JBAIDS assay format; 5. Initiate a real-time stability program to demonstrate 18-month (T) or 24-month (O) shelf life of the freeze-dried assays. The offeror/company would conduct pre-clinical trials and clinical trials on the assays developed to support submission of a 510(k) package(s) to the U.S. Food and Drug Administration. DoD would sponsor the 510(k) submission to the FDA with the developing company being designated as the clinical research organization (CRO). Responses: The JPMO CBMS expects to award a contract this fiscal year (2010). If qualified and capable, please respond and include a description of your companys experience and resources that meet the following: 1. Possession of a system science and methodology, and proven expertise to development freeze-dried PCR virus assays and has supporting test data to validate virus influenza identification performance claims. 2. Ability to develop the five IVD assays noted above, knowledge of the FDA clearance process, and a plan for your companys assay candidate(s) to operate on the JBAIDS analyzer. 3. Access to FDA cGMP (Current Good Manufacturing Practices) compliant manufacturing facilities capable of producing thousands of assays monthly for multiple influenza viruses. 4. Eligibility to receive a DoD secret-level facility clearance and key personnel clearances by the time assay development is completed (approximately 12 months after contract award). 5. Capability of delivering some influenza test assays no later than 12 months after contract award in a freeze-dried format. Interested companies are requested to respond in writing to JBAIDS.EXP.FLU.Panel@ AMEDD.Army.Mil by 13 November 2009. Provide contact name, phone number, email address and mailing/street address, and description of company capabilities in 15 pages or less. Responses shall be unclassified; proprietary information should be identified as Company Proprietary. The preferred response method is email using file formats such as Microsoft Word, Portable Document Format (pdf), or Microsoft Power Point. However, CDs, printed information, or similar will be accepted if sent to US Army Space & Missile Defense Command, ATTN: Cynthia Gnam, 64 Thomas Johnson Drive, Frederick, Maryland 21702. Early responses are encouraged. Companies qualified to develop the PCR influenza assays will be invited to brief (not more than three hours in duration) in person, by VTC, or via internet before 24 November 2009. This announcement and any additional information, when released, may also be found on the Joint Program Executive Office for Chemical and Biological Defense (JPEO CBD), CBMS opportunities, at: http://www.jpeocbd.osd.mil/packs/Default.aspx?pg=1214&title=CBMS%20-%20Current%20Opportunities Any questions regarding this Research and Development Sources Sought should be submitted to JBAIDS.EXP.FLU.Panel@AMEDD.Army.Mil.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/SMDC/DASG60/W9113M-10-R-0003/listing.html)
- Place of Performance
- Address: US Army Space and Missile Defense Command, Deputy Commander ATTN SMDC-CM-EB Frederick MD
- Zip Code: 21702
- Zip Code: 21702
- Record
- SN01991141-W 20091025/091023234919-d4a2866ae90e05957f2f1a6aa1e6c43a (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |