1.0 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 developing an assay cartridge for the i-STAT® and submitting the assay and device for approval by the Food and Drug Administration (FDA) for the detection of protein biomarkers that are associated with Traumatic Brain Injury (TBI).     

2.0 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.

3.0 DESCRIPTION:  USAMMDA 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 using antigen-antibody interactions.  There is an interest in assays that can detect low levels of these blood proteins, < 50pg/ml of whole blood using the i-STAT®. Furthermore, this request is for information that discusses the development 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. 

4.0 SUBMISSION INSTRUCTIONS:   Entities interested in submitting a response must furnish in writing, a 1-2 page (not including cover page, index or list of references) synopsis of their capability to perform assay development,testing and FDA submission of  an assay cartridge designed for the i-STAT® to detect protein biomarkers associated with TBI.  Companies responding to this notice must provide complete contact information (telephone, address, email address). Responders must identify their company’s business size (based on the NAICS size standard), business status (i.e. small business, disadvantaged, HUB zone, woman owned, service disabled veteran owned).  Please also include information regarding any prior experience with U.S. Government contracts and favorable experience working with the FDA. 

5.0  SUBMISSION CONTACT INFORMATION:  Interested entities shall forward submissions to Herbert Caj Keen at [email protected] no later than the close of business 12 APR 2016.  Telephonic communication will not be considered as submission or receive response.