Loren Data's SAM Daily™

FBO DAILY ISSUE OF JULY 24, 2004 FBO #0971
SOURCES SOUGHT

A -- CRO for Point-of-Care assays to diagnose militarily relevant infectious diseases and to take these forward under the most appropriate regulatory mechanism for FDA clearance or approval

Notice Date

7/22/2004
 

Notice Type

Sources Sought
 

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-POINT-OF-CARE
 

Response Due

10/29/2004
 

Archive Date

12/28/2004
 

Point of Contact

Cheryl Miles, 301-619-7148
 

E-Mail Address

Email your questions to US Army Medical Research Acquisition Activity
(cheryl.miles@det.amedd.army.mil)
 

Small Business Set-Aside

N/A
 

Description

The point-of-contact for this announcement is Mr. Scott Doughty (scott.doughty at amedd.army.mil). THIS IS NOT A SOLICITATION ANNOUNCEMENT. This is a sources sought synopsis only. The purpose of this sources sought synopsis is to gain knowledge of po tential qualified sources for planning purposes only for the U.S. Army Medical Materiel Development Activity (USAMMDA), Fort Detrick, Maryland. Its mission is to protect and preserve the lives of America's sons and daughters by providing new drugs, vaccine s, and medical devices that enhance readiness, ensure the provision of the highest quality medical care to DoD, and maximize the survival rate for medical casualties on the battlefield. USAMMDA is seeking a Contract Research Organization (CRO) to develop a variety of ??????Point-of-Care?????? (POC) assays to diagnose militarily relevant infectious diseases and to take these forward under the most appropriate regulatory mechanism for FDA clearance or approval, and ensure that they remain commercially availab le for use by the U.S. military for a minimum of 5 years. Collaborations with USAMMDA would be required for the test and evaluation of these assays to ensure that they meet military requirements. The CRO would be responsible for preparing a 510(k) applica tion or PreMarket Approval Application (PMA), as appropriate, for submission to the FDA for each assay, and must ensure that these assays are available for purchase by the U.S. military once cleared or approved by the FDA. We envision that POC assays are r apid detection devices capable of determining whether clinically ill soldiers are infected with a particular pathogen. The assay should detect the pathogen OR an alternative bio-marker that is specific for the pathogen. The assay must be rapid (less then 30 min), one- or two-step format, and stable (storage at 35 degrees C for 2 years). The assay should be 85 percent sensitive and 85 percent specific for the particular agent compared to current reference diagnostic assays. The assay must be soldier-friendl y (i.e., easy to operate), inexpensive, portable, use heat-stable reagents, and have no special storage requirements. A standardized platform is desired (i.e., if multiple assays are provided they should all be similar in design). Pathogens for which we d esire POC-DD include: Leishmania sps. (assay detects all species of Leishmania), flaviviruses (detects all flaviviruses), alphaviruses (detects all alphaviruses), bunyaviruses (detects all bunyaviruses, dengue virus, Rickettsia typi, Rickettsia rickettsia, Orientia tsutsugamushi, various enteric pathogens (Cryptosporidium, E. coli, Shigella sps., Salmonella sps., etc.), and hantaan virus. Additional assays are envisioned. Sample matrix will depend on the pathogen of interest (e.g., skin scrapings will be used to test for Leishmania, whole blood or sera for dengue virus, and stool samples for Shigella).Ideally the FDA-cleared 510(k) application or approved PMA would be held and managed by the CRO, although consideration could be given to the U.S. Army Medic al Research and Materiel Command holding the application and the CRO managing it. The CRO should be able to demonstrate that they have the ability and experience to successfully develop an FDA-cleared or approved diagnostic assay. A short fact sheet (less than 3 pages) is requested that summarizes capabilities of the CRO in completing the requirements identified above. However, this announcement is not a formal solicitation and is not a request for proposal. No contract will be awarded from this announceme nt. No reimbursement will be made of any costs to provide information in response to this announcement or any follow up information requests. Availability of any formal solicitation will be announced under a separate announcement. This synopsis is for info rmation and planning purposes only and is not to be construed as a commitment by the Government. Each response must reference the sources sought title. All prop rietary information should be marked as such. Responses will be held confidential if requested. Please submit fact sheets to the attention of: USAMMDA, ATTN: MCMR-UMP, 622 Neiman Street, Fort Detrick, MD 21702-5009. Fact sheets may be emailed to: Scott.Do ughty at amedd.army.mil. Responses must be received no later than October 29, 2004, by 4:00 P.M. Eastern Standard Time.
 

Place of Performance

Address: US Army Medical Research Acquisition Activity ATTN: MCMR-AAA, 820 Chandler Street Frederick MD

Zip Code: 21702-5014

Country: US
 

Record

SN00628742-W 20040724/040722212443 (fbodaily.com)
 

Source

FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

---

| FSG Index  |  This Issue's Index  |  Today's FBO Daily Index Page |