SOLICITATION NOTICE
A -- Medical Devices for the Detection of Tranfusion Transmitted Diseases
- Notice Date
- 3/7/2011
- 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-11-R-0016
- Response Due
- 7/7/2011
- Archive Date
- 9/5/2011
- Point of Contact
- Shavon Baker, 301-619-2664
- E-Mail Address
-
US Army Medical Research Acquisition Activity
(shavon.baker@us.army.mil)
- Small Business Set-Aside
- N/A
- Description
- A solicitation will be posted on or about 23 March 2011 for the development of medical devices for the detection of transfusion transmitted diseases. 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. 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. tests for prescreening deployed military forces for Transfusion Transmitted Diseases (TTDs). The requirements identified in the solicitation are to develop two highly sensitive, highly specific, rapid and easy to use disposable Immunologic Clinical Screening devices for use in a technologically constrained, deployed environment. Offerors may submit proposals for the development of one or multiple devices. Devices are needed for the: (1) detection of HBV Surface Antigen (HBsAg); and (2) simultaneous detection of multiple TTDs to include, but not limited to, HBV, Hepatitis C Virus (HCV) and Human Immunodeficiency Virus 1 and 2 (HIV 1/2). The multiplex assay should test for all HBV genotypes and should ideally include two targets for HBV, anti-HBc and HBsAg, though proposals will be considered for devices that detect only one of these targets. The multiplex assay for anti-HCV should test for all HCV genotypes. The multiplex assay should detect both anti-HIV-1 and anti-HIV-2. The Offeror shall have a functioning prototype device and testing data to support substantial equivalency to a predicate device (if such a predicate exists), and the testing data shall demonstrate that the device can at a minimum meet the Threshold Performance Attributes described in the upcoming solicitation. All efforts shall be in accordance with FDA processes and requirements for medical device clearance. 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.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH-11-R-0016/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
- SN02394717-W 20110309/110307234248-a648ff1dd4ccacccb49e8c951895ac9f (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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