Loren Data's SAM Daily™

FBO DAILY ISSUE OF MAY 10, 2012 FBO #3820
DOCUMENT

A -- ADVANCED DIAGNOSTICS FOR FIELD-BASED BIOSURVEILLANCE - Link to BAA Instruction webpage.

Notice Date

5/8/2012
 

Notice Type

Link to BAA Instruction webpage.
 

NAICS

541711 — Research and Development in Biotechnology
 

Contracting Office

Department of the Navy, Office of Naval Research, Naval Research Laboratory, 4555 Overlook Ave. S.W., Washington, District of Columbia, 20375
 

ZIP Code

20375
 

Solicitation Number

BAA-N00173-6101
 

Point of Contact

Mary A. Johnson, Phone: 2027672021, Carol A Parnell, Phone: 202-767-2372
 

E-Mail Address

mary.johnson@nrl.navy.mil, carol.parnell@nrl.navy.mil
(mary.johnson@nrl.navy.mil, carol.parnell@nrl.navy.mil)
 

Small Business Set-Aside

N/A
 

Description

The Naval Research Laboratory (NRL) is looking for Research & Development to advance technology development of mature in vitro diagnostic devices that are amenable to military hardening and integration with communication capabilities to support the biosurveillance needs of the US military. Desired Design and Performance Capabilities : The Government is interested in proposals offering innovative approaches for in vitro diagnostics devices (technology readiness level, TRL 5 or greater and a TRL of 7 after 24 months of funded R&D; See Appendix A for assay-type TRL definitions) for the following two use cases: Role 0 : Highly robust self-collection and presumptive diagnostic screening modality (analogous to home glucose or pregnancy testing), medical diagnostic devices demonstrating CLIA-waived status (i.e., low complexity), specifically for use in austere environments and capable of entry to "telemedicine/remote consultation" electronic treatment/management hierarchy and defined reflexivity to higher level of care. Such a device should demonstrate sufficient analytical sensitivity and negative predictive value for infectious disease screening applications. No assumption should be made by Offerors as the mode of communication (e.g., telemedicine) of the analytical result. The only requirement is that the communication of the resulting analytical data is possible via electronic means (e.g., voice, text message, email, image et cetera), and that the algorithm by which the diagnostic information is generated and provided to the patient and physician, be remote to the device itself. Role 1 : Handheld and CLIA-waived/waiver-capable diagnostic devices/analyzers that are more highly multiplexed and designed for diagnostic/confirmatory field use by a medically trained operator in a "primary care" setting (i.e., field clinic, urgent care facility, Level 1 Medical Treatment Facility, Shock Trauma Platoon, etc. ). Important assumptions for these environments include that they no surgical or patient holding capability, are manned by a Physician, Physician Assistant (PA), or Medic, with the mission of providing triage, and treatment to return military personnel to duty, or stabilizing them for evacuation to the next level care facility (may be chemical & biological protected). Devices should demonstrate sufficient analytical sensitivity, specificity and total (positive and negative) predictive value for infectious disease diagnostic and confirmatory applications. In both cases, proposals are sought for medical diagnostic devices that have been designed to deliver information that will be used to facilitate the diagnosis of diseases whose origin is an infectious agent pathogen or toxin (organized as panels by syndromic presentation or pathogen class),and/or biomarkers of exposure to said agents. Analytes of interest include both pathogen and pathogen class-differential diagnostic markers. The ability to differentiate between pathogens such as Malaria (specifically P. falciparum), Arboviral diseases (e.g. dengue, chikungunya, etc.), Typhoid, Arenaviral diseases, Rickettsial diseases, Viral hemorrhagic fevers (VHF) (including arenaviruses above), Plague, Q fever (Coxiella burnetti), Tularemia (Francisella tularensis), and Anthrax(B. anthracis) is desirable. It is not a requirement that the device technology fulfilling the requirements outlined in Role 0 or Role 1 above be specifically designed for these pathogens/diseases, but it is preferable that the technology be adaptable to such pathogens/diseases. One specific matrix of interest is blood with either a finger prick or venous blood draw by a medic or trained medical personnel. It is not a requirement that the device technology be designed for a blood matrix but it is preferable that it be adaptable enough to enable diagnostics on a blood matrix. NRL will work cooperatively with the Offeror to test and verify performance of the devices and to assist in the integration of the diagnostic devices with communication and device hardening for field application. Additional background information may be found here: https://www.fbo.gov/index?s=opportunity&mode=form&id=eb0d8db0d46f190ee282a8e70b7ef768&tab=core&_cview=1 Anticipated Period of Performance : It is anticipated that the 24-Month Challenge program shall provide up to two years of funding for research and development through competitive prototyping. The timeline will be divided into a Base Period of no more than 7 months, an additional Option 1 phase of 7-8 months, and a final Option 2 phase of 7-8 months. These phases include device development, testing and demonstration, evaluation, reporting, and selection activities. Selection of device candidates to be advanced into the Option 1 and Option 2 phases will be based on specific parameters and metrics being successfully met in demonstration exercises. The government shall provide technical data and support for demonstrations, as well as facilitate interaction with relevant DoD and Interagency stakeholders. The following presents a timeline that lists the anticipated sequence of major milestones for this program. 1 Jan 2013: Prototype I testing completed - Base period complete 31 Jan 2013: Down selection, Initiate Prototype II development - Option 1 awarded 28 Jun 2013: Prototype II testing completed - Option 1 complete 30 Aug 2013: Down select - Operational demo - Option 2 awarded 28 Feb 2014: Operational demo completed - Option 2 complete Award : The Government reserves the right to make single or multiple awards. It is anticipated that award will be in the form of a cooperative agreement. The total amount of funding available is approximately $2M.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/DON/ONR/N00173/BAA-N00173-6101/listing.html)
 

Document(s)

Link to BAA Instruction webpage.
 

File Name: Link to BAA Instruction webpage. (http://heron.nrl.navy.mil/contracts/index6101.htm)

Link: http://heron.nrl.navy.mil/contracts/index6101.htm

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN02741926-W 20120510/120508235039-c508b41e934734412cd2f16d9265b48d (fbodaily.com)
 

Source

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

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