SPECIAL NOTICE
A -- Biomarkers of Neurological Injury for the Encephalitic Alphaviruses
- Notice Date
- 3/2/2021 9:22:30 AM
- Notice Type
- Special Notice
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- NAVAL MEDICAL LOGISTICS COMMAND FORT DETRICK MD 21702-9203 USA
- ZIP Code
- 21702-9203
- Solicitation Number
- ADVFY21RD100007
- Response Due
- 3/17/2021 10:00:00 AM
- Archive Date
- 04/17/2021
- Point of Contact
- Cheryl Vendemia, Phone: 3016196004
- E-Mail Address
-
cheryl.r.vendemia.civ@mail.mil
(cheryl.r.vendemia.civ@mail.mil)
- Small Business Set-Aside
- SBA Total Small Business Set-Aside (FAR 19.5)
- Description
- The Naval Medical Logistics Command (NMLC) intends to award a sole source contract to Banyan Biomarkers for technical and research subject matter expertise services in support the Naval Medical Research Center (NMRC), Fort Detrick MD, coordinated effort to carry out activities for their study titled Biomarkers of Neurological Injury for the Encephalitic Alphaviruses (BNIEA). The original development of the protein biomarkers UCH-L1 and GFAP in human serum assay was funded in part by the Army for the diagnosis of traumatic brain injury (TBI). As a result of this research, the Banyan BTI� was discovered, FDA approved, and patented by Banyan Biomarkers. The NMRC recently obtained the Banyan BTI� kits and equipment that are no longer in use as part of the U.S. Army Medical Materiel Development Activity�s (USAMMDA) TBI program for use in this research study. The research study will evaluate the feasibility of using the Banyan BTI� platform (to diagnose traumatic brain injury in humans and in non-human primates infected with encephalitic alphaviruses.� The Banyan BTI� kits and equipment are being used for two reasons; its availability to NMRC and its patented Food and Drug Administration (FDA) approved method for using protein biomarkers in human serum assays to detect traumatic brain injury, which is closely related to this research effort. To carry out this effort, the Immunodiagnostics Department at NMRC/BDRD requires a source that is capable of providing technical and research subject matter expertise non-personal services with intimate knowledge of the Banyan BTI� kits and equipment. This technical and research subject matter expertise is needed to assist the NMRC in determining the feasibility of adapting the same protein biomarkers in the Banyan BTI� kits (ubiquitin carboxy-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein (GFAP) in human serum) to detect human cases of encephalitis due to alphavirus infection.� These services will also assist the NMRC to determine if these same protein biomarkers can be detected in non-human primates infected with the encephalitic alphaviruses. This effort requires subject matter expertise to review and provide guidance on the planning and execution to NMRC using Banyan BTI� to carry out activities associated with the BNIEA study. The overall goal of the study is to identify biomarkers to monitor disease progression, direct treatment, and as reliable end-points to help develop medical countermeasures for the encephalitic alphaviruses. More generally, these studies will establish the first research paradigm to validate systematically the use of blood biomarkers for the clinical diagnosis of brain injury associated with viral infections. The research to be conducted under this effort must use the FDA approved Banyan BTI� kits� to utilize the protein biomarkers in the Banyan BTI� kits for the reasons outlined above. � If capable sources are not identified through this notice, NMLC intends to award a sole source contract under the authority of FAR 6.302-1 (one source) to Banyan Biomarkers, 16470 W. Bernardo Drive, Suite 100, San Diego, CA, 92127. � Banyan Biomarkers is the only source that has received FDA approval for the patented Banyan BTI� and they are the only known source with the unique capabilities and intimate knowledge to provide technical and research subject matter expertise to assist the NMRC in carrying out this research effort. � This notice is not a request for competitive proposals and no solicitation document exists for the requirement.� Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data and cost information in sufficient detail and with convincing evidence that clearly demonstrates the capability to perform the required work.� Capability statements shall not exceed 5 (8.5 x 11 inch) pages using a font size no smaller than 10-point.� All capability statements received by the due date of this notice will be considered by the Government.� A request for documentation or additional information or submissions that only ask questions will not be considered as an affirmative response.� A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government.� Information received will be considered solely for determining whether to conduct a competitive procurement or to proceed with a sole source contract. Capability statements are due by 1:00 PM Eastern Time, 17 March 2021. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following address: cheryl.r.vendemia.civ@mail.mil. No phone calls will be accepted.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/597e09517f954de5bfd0b033e899af2b/view)
- Place of Performance
- Address: Frederick, MD 21702, USA
- Zip Code: 21702
- Country: USA
- Zip Code: 21702
- Record
- SN05930414-F 20210304/210302230104 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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