SOURCES SOUGHT
A -- Request for Information
- Notice Date
- 1/4/2018
- Notice Type
- Sources Sought
- 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
- W81XWH-10-C-0251
- Archive Date
- 1/25/2018
- 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
- Request for Information (RFI) 1.0 RFI TITLE: Develop TBI Assay using Banyan Biomarker's Ubiquitin C-terminal Hydrolase (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP) reagents for use on a small, self-contained, field ready benchtop device. 2.0 AGENCY: United States Army Medical Research and Materiel Command 3.0 OFFICE: United States Army Medical Materiel Development Activity 4.0 LOCATION: Fort Detrick, Maryland 5.0 SUBJECT: The U.S. Army Medical Research and Materiel Command (USAMRMC) is working to develop U.S. Food and Drug Administration (FDA)-approved self-contained, field ready benchtop device to improve assays specific for UCH-L1 and GFAP biomarkers, to serve as an aid for evaluating mild TBI by detecting the presence of TBI-induced blood proteins using antigen-antibody interactions. USAMRMC currently intends to modify Contract W81XWH-10-C-0251, adding new work to develop a less than 1 hour UCH-L1/GFAP Assay on a self-contained bench top device that has minimal associated equipment and reduces the logistical burden in military operations. This out of scope modification will be awarded to Banyan Biomarkers under statutory authority 10 U.S.C. 2304(c)(1) as implemented by FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. 6.0 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 or any follow-up information request. All information received in response to this RFI or any follow-up information request that is marked Proprietary will be handled accordingly. Responses to the RFI will not be returned. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. However, if a competitive solicitation is released, it will be synopsized on the Government-wide Point of Entry. It is the responsibility of potential offerors to monitor the Government-wide Point of Entry for additional information pertaining to this requirement. 7.0 DESCRIPTION: During the past decade, over 340,000 service members have been diagnosed with a brain injury. Greater than 80% of these brain injuries have been classified as mild TBI (mTBI). However, the current testing methods that are available to diagnose battlefield brain injury are subjective and often rely on self-report of injury occurrence and symptoms. The military need to diagnose and triage TBI casualties is described in the Theater Combat Casualty Care Initial Capability Document dated October 2007 and the Joint Force Health Protection Joint Casualty Management Joint Capabilities Document dated June 11, 2008. There is widespread agreement among subject matter experts that there is no clinically validated device for the diagnosis of mild TBI (mTBI). There is an interest in assays that can detect low levels of these blood proteins, in serum, using standard ELISA assays, compressed time ELISA assays and/or compact, self-contained, field ready devices. The U.S. Army has worked in collaboration with Banyan Biomarkers to discover and test protein biomarkers of TBI. To date, Ubiquitin C-terminal Hydrolase (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP) have been tested in multiple clinical trials of patients with mild, moderate and severe TBI. The key objective in completing the requirements for this contract is FDA approval of the biomarker(s) for a TBI indication for use. This requirement is for additional work to improve assays developed by Banyan Biomarkers Inc that are specific for UCH-L1 and GFAP biomarkers, to serve as an aid for evaluating mild TBI by detecting the presence of TBI-induced blood proteins using antigen-antibody interactions. The first improvement requires Banyan to develop a <1 hour UCH-L1/GFAP Assay using the same reagents currently optimized on the Synergy II Biotek instrument (device). Faster assay time is necessary because the assay on the benchtop device has a significant run time, which in turn means the assay has a low clinical utility. The second improvement requires Banyan to develop the assay on a self-contained bench top device that has minimal associated equipment and therefore reduces the logistical burden in military operations. 8.0 SUBMISSION INSTRUCTIONS: In response to this sources sought, please provide the following information to the U.S. Army Medical Research Acquisition Activity (USAMRAA) Contract Specialist, Herbert Caj Keen, at herbert.e.keen.civ@mail.mil. Telephonic communication will not be considered as submission nor receive a response. Email submissions must be received no later than 4:00 PM Eastern on 10 January 2018. 8.1. Identify any condition or action that may be having the effect of unnecessarily restricting competition with respect to this acquisition and identify alternatives or solutions. Provide the specific aspects that unreasonably restrict competition and the rationale for such conclusion. 8.2. Name of the firm, point of contact, phone number, email address, DUNS number, CAGE code, identify business size (large business or a small business), 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. 8.3. Identify whether your firm is interested in competing for a follow-on requirement as a prime contractor or not. Identify subcontracting, joint ventures or teaming arrangement that will be pursued, if any. 8.4. Information in sufficient detail regarding 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.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH-10-C-0251/listing.html)
- Place of Performance
- Address: N/A, United States
- Record
- SN04781088-W 20180106/180104230650-a27a9ef4b37503cfc8440f8e437f14b9 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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