SPECIAL NOTICE
99 -- RFI - TBI Assay Cartridge
- Notice Date
- 6/11/2018
- Notice Type
- Special Notice
- NAICS
- 541714
— Research and Development in Biotechnology (except Nanobiotechnology)
- Contracting Office
- Department of the Army, U.S. Army Medical Research Acquisition Activity, U.S. Army Medical Research Acquisition Activity, Attn: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014, Maryland, 21702-5014, United States
- ZIP Code
- 21702-5014
- Solicitation Number
- RFI-TBI-Assay-Cartridge
- Archive Date
- 7/3/2018
- Point of Contact
- Herbert Caj Keen, Phone: 3016191011
- E-Mail Address
-
herbert.e.keen.civ@mail.mil
(herbert.e.keen.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- 1.0 RFI TITLE: Development and U.S. Food and Drug Administration (FDA) approval to market for a TBI Assay Cartridge for the i-STAT®, using Ubiquitin Carboxy-terminal Hydrolase-L1 (UCH-L1) and Glial Fibrilliary Acidic Protein (GFAP) protein biomarkers. 2.0 AGENCY: Unites States Army Medical Materiel Development Activity (USAMMDA) 3.0 OFFICE: Neurotrauma and Psychological Health Program Management Office (NPH PMO) 4.0 SUBJECT: In support of the U.S. Army Medical Materiel Development Activity's (USAMMDA) mission to develop and manage medical materiel to protect and sustain the Warfighter, this request for information is seeking entities capable of achieving FDA market approval of an assay cartridge for the i-STAT® for the detection of protein biomarkers that are associated with Traumatic Brain Injury (TBI). 5.0 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. At this time, the Government intends to award a contract to Abbott Laboratories using other than full and open competition using the authority at FAR 6.302-1. This Request for Information is being published in accordance with DFARS PGI 206.302-1. 6.0 DESCRIPTION: USAMMDA NPH PMO is requesting information from companies capable of developing a FDA approved assay cartridge that will be utilized on the fielded medical device, i-STAT®, to serve as an aid for diagnosing mild and moderate TBI by detecting the presence of TBI-induced blood proteins, UCH-L1 and GFAP, using antigen-antibody interactions. There is an interest in assays that can detect low levels of these blood proteins, < 50 pg/ml of whole blood, using the i-STAT®. Furthermore, this request is for information that discusses the FDA market approval of an i-STAT® assay cartridge which will be used with antibodies developed by Banyan Biomarkers Inc. that are specific for UCH-L1 and GFAP biomarkers. 7.0 SUBMISSION INSTRUCTIONS: Entities interested in submitting a response must furnish a Capabilities Statement. Submissions shall be kept to one to three pages. The subject header of the email for submission of questions and/or the RFI response shall be: RFI Response: FDA-approved blood assay for traumatic brain injury (TBI). All information regarding capabilities statements or any other proprietary information relative to this RFI shall be marked appropriately. Submission should include the following information: 7.1 Name of the firm, point of contact, phone number, email address, DUNS number, CAGE code, and if applicable, a statement regarding small business status (including small business type(s)/certifications(s) such as SDB, 8(a), HUBZone, SDVOSB, WOSB, etc.) and the corresponding NAICS code. 7.2 Information in sufficient detail regarding how your firm is able to meet this requirement, as well as previous experience (indicate whether as a prime contractor or subcontractor) on similar requirements (include size, scope, complexity, timeframe, government or commercial), pertinent certifications, etc., that will facilitate making a capability determination. 6.0 SUBMISSION CONTACT INFORMATION: Interested entities shall forward submissions to Herbert Caj Keen at herbert.e.keen.civ@mail.mil no later than the close of business 18 JUNE 2018. Telephonic communication will not be considered as submission or receive response.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/RFI-TBI-Assay-Cartridge/listing.html)
- Place of Performance
- Address: Fort Detrick, Maryland, 21702, United States
- Zip Code: 21702
- Zip Code: 21702
- Record
- SN04951383-W 20180613/180611231049-71b83c96b6ce039126a2abfc7fbf03ec (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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