SOLICITATION NOTICE
A -- Medical Devices for the Detection of Transfusion Transmitted Diseases
- Notice Date
- 6/4/2010
- Notice Type
- Presolicitation
- 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-10-R-0025
- Response Due
- 8/9/2010
- Archive Date
- 10/8/2010
- Point of Contact
- Shannyn Scassero, 301-619-2640
- E-Mail Address
-
US Army Medical Research Acquisition Activity
(shannyn.scassero@det.amedd.army.mil)
- Small Business Set-Aside
- N/A
- Description
- This solicitation is a Performance Based Acquisition. The Government may issue one contract or multiple contracts as a result of this solicitation. Any contract(s) issued as a result of this solicitation shall include Cost Reimbursement terms and conditions. The Government herein anticipates a period of performance of two (2) years with one (1) one-year option period (depending upon the starting maturity of the medical device). Contracts shall be issued on a best value basis. HISTORICAL INFORMATION: No previous history. The U.S. Army Medical Research and Materiel Command (USAMRMC) has a requirement for U.S. Food and Drug Administration (FDA) cleared medical devices for prescreening deployed military forces for Transfusion Transmitted Diseases (TTD) and for blood donor screening for TTDs. There are both interim and long term goals for this effort. The interim goal is the development of FDA cleared medical devices for rapid clinical screening assays for Hepatitis B virus (HBV) and Hepatitis C virus (HCV). The long term goal is the development of a FDA cleared rapid and portable medical device for combined/multiplex nucleic acid testing for blood donor screening for HBV, HCV and Human Immunodeficiency virus-1/2 (HIV-1/2) that is suitable for use in a deployed and technologically constrained environment. The ultimate aim is to be able to screen potential blood donors to produce blood products in the deployed setting with methods that mirror as closely as possible the current Good Manufacturing Practices (cGMPs) used to produce products in licensed blood donor centers according standards set by the FDA. The goals of this solicitation are to develop Rapid Immunological Clinical Screening Assays for HBV and HCV and Rapid Nucleic Acid Test(s) for Blood Donor Screening to Detect and Differentiate HBV, HCV and HIV-1/2.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH-10-R-0025/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
- SN02169185-W 20100606/100604235205-6e048afb043598f48d4217dfe955f94c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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