The attached amendment is to provide answers to questions received, modify the response date, provide an addition question and answer period, revise the white paper page limits and modify the anticipated period of performance.
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the naval research laboratory (nrl) is seeking research & development partners to advance technology developed for in vitro diagnostic devices that are amenable to military hardening and integration with communication capabilities to support the biosurveillance needs of the us military in field forward locations. Syndromic approaches on devices capable of detecting diseases that cause febrile illness are specifically sought.
Desired design and performance capabilities
the government is interested in proposals offering innovative approaches for in vitro diagnostics devices (technology readiness level (trl) of 4 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:
genomic analysis platforms: devices capable of examining molecular sequences, specifically dna and/or rna, to provide positive identification of the causative agent of febrile illness. Analysis should be multiplexed (minimum of three, preferred more than 4) to provide a syndromic approach to disease identification; including sub-classification for diseases as appropriate (e.g., serotypes 1, 2, 3, and 4 for dengue virus, differentiation of ebola strains). Genomic analysis must be compatible with whole blood starting material and be performable in field forward settings.
High performance immuno-analysis platforms: devices capable of identification of immunological targets that provide identification of the causative agent of febrile illness. Analysis should be multiplexed (minimum of three, preferred more than 4) to provide a syndromic approach to disease identification; including sub-classification for diseases as appropriate. Assays for immunological targets that indicate acute infections are preferred, particularly for deployment in endemic areas. Immuno-analysis must be compatible with whole blood starting material and be performable in field forward settings.
In either use case, the device and assay must have the following characteristics: the device must be a low-complexity diagnostic device usable by personnel following minimal training. A total sample to answer timeframe of one hour or less is preferred. The final technology package should be for use in field forward, often austere environments with limited resources, and capable of entry to "telemedicine/remote consultation" electronic treatment/management hierarchy. Important assumptions for these environments include that they have 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. The device must have communications ability. The only requirement is that the communication of the resulting analytical data is possible via electronic means (e.g., 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. The device should have battery capability that assures no disruption in assay completion should field conditions change abruptly. Full battery operation with periodic battery charging is preferred. It is not required that the device is handheld, but the physical parameters of weight and footprint will be evaluated.
Devices should demonstrate sufficient analytical sensitivity, specificity and total (positive and negative) predictive value for infectious disease diagnostic applications. The devices and assays should be designed to diagnosis 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 (specifically lassa fever), plague, tularemia (francisella tularensis), and melioidosis (burkholderia pseudomallei) is desirable. It is not a requirement that the device technology fulfilling the requirements outlined above be specifically designed for these pathogens/diseases, but the technology must be easily adaptable to such pathogens/diseases. The specific matrix of interest is blood, with preference for finger prick sample collection. It is not a requirement that the device technology be already designed for a blood matrix but the technology must be adaptable to work from a whole blood sample. A full use scenario from sample collection, through sample preparation, to answer must be offered with preference given to fully automated and user-friendly solutions.
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. The offeror must demonstrate manufacturing capability, or partnerships for manufacturing, that assure prototype devices and assays will be available for field deployment and testing at the end of the performance period.
Any potential international traffic in arms regulations (itar) restrictions, including any anticipated restrictions likely to be generated by the proposed work plan, must be listed.
Anticipated period of performance
it is anticipated that the development of field forward diagnostics and tiered evaluation program shall provide up to two years of funding for research and development through competitive prototyping. The timeline will be divided into three tiers. The first tier will be no more than 5 months and benchmark the performance of the offerors technology with the assay that best matches the stated diagnostic needs. An optional second tier can be activated that engages the offeror in research development of the technology to meet the specific needs outlined with a performance period up to 12 months. Following the performance period, the developed technology will be benchmarked by nrl. Finally, an optional third tier of 3-9 months can be activated for the field deployment of the developed technology. These tiers include device development, testing and demonstration, evaluation, reporting, and selection activities. Selection of device candidates to be advanced into tier 2 and tier 3 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.
31 august 2015: tier 1 testing complete
7 september 2015: down selection, initiate tier 2
1 july - 1 october 2016: tier 2 development complete
1 november 2016: tier 2 testing complete
30 november 2016: down selection, initiate tier 3
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.
Appendix a: diagnostic technology readiness level (trl) statements
pcr assay trl definitions
trl 1. Requirement identified, molecular targets not defined or not yet identified. May require basic research (sequencing, etc.)
trl 2. Potential target sequences identified, but no lab testing. Paper chemistry only.
Trl 3. Initial assay development and evaluation. Assay design (primers, probes) and assay format (taqman, fret, etc.) locked down
trl 4. Home brew assay. Buffer only, no scale-up, not optimized on any real-time platform
trl 5. Bench scale pilot reagent manufacturing with some mfg. Controls. Not fully qualified/validated, but some testing in relevant sample types.
Trl 6. Some degree of validation in relevant sample matrices, but only in expert user hands. Cb.56 data package in development.
Trl 7. Cb.56 data package complete and on file. More complete validation, plus multiple lots manufactured and tested by users outside developing lab in relevant sample types. Ideal transition point.
Trl 8. Fully validated, tested by end users under operational conditions, eligible for fda clearance/approval, ide.
Trl 9. Fda-cleared/approved (clinical diagnostic applications only) or otherwise independently validated/accepted (e.g., aoac, usda, cdc).
Immunoassay trl definitions
trl 1. Requirement identified, antigenic targets not yet identified or no antibodies available. May require basic research (sequencing, etc.)
trl 2. Potential antigenic targets identified, but no lab testing, or antibodies being generated or still at crude serum stage. Reagent performance not yet characterized for utility.
Trl 3. Initial assay development and evaluation. Assay design (antibodies or other asr s*) and assay format (e.g., handheld vs. Instrument based, sandwich, competitive, etc.) locked down
trl 4. Home brew assay. Buffer samples only, no scale-up, optimized on at least one platform
trl 5. Bench scale pilot reagent manufacturing with some mfg. Controls. Not fully qualified/validated, but some testing in relevant sample types.
Trl 6. Some degree of validation in relevant sample matrices, but only in expert user hands. Cb.56 data package in development.
Trl 7. Cb.56 data package complete and on file. More complete validation, plus multiple lots manufactured. Assay tested by users outside developing lab in relevant sample types. Ideal transition point.
Trl 8. Fully validated, tested by end users under operational conditions, eligible for fda clearance/approval, ide.
Trl 9. Fda-cleared/approved (clinical diagnostic applications only) or otherwise independently validated/accepted (e.g., aoac, usda, cdc).
*asr = analyte-specific reagent
added: jun 16, 2015 9:39 am
this solicitation is being amended to correct the email address identified in amendment 01 to submit questions. The correct email address is
[email protected] and all questions are due by 12:00pm est on june 16, 2015. Please consult the list of document viewers if you cannot open a file.
Baa instructions
type: other (draft rfps/rfis, responses to questions, etc..) label:
baa instructions
posted date: may 26, 2015 http://heron.nrl.navy.mil/contracts/openbaas.htm
description: open specific baa
award considerations
type: other (draft rfps/rfis, responses to questions, etc..) label:
award considerations
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Http://heron.nrl.navy.mil/contracts/baa/baa_2013/awardconsider03.html
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baa introduction
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baa introduction
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representations and certifications
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representations and certifications
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white paper and proposal preparation
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white paper and proposal preparation
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amendment 1
type: mod/amendment posted date: june 9, 2015 n0017315rba01_amendment_01.pdf (97.55 kb)
description: amendment 01
contractor s location
united states
primary point of contact.:
mary a. Johnson
[email protected]phone: 2027672021secondary point of contact:
lisa a fleming
[email protected]phone: 202-767-3739
fax: 202-767-6197 all files
baa instructions
may 26, 2015
open specific baaaward considerations
may 26, 2015
considerationsbaa introduction
may 26, 2015
introrepresentations and certifications
may 26, 2015
reps and certswhite paper and proposal preparation
may 26, 2015
preparationamendment 1
jun 09, 2015
n0017315rba01_amendm...download/view n0017315rba01_amendment_01.pdfgeneral information
lisa a fleming
[email protected]phone: 202-767-3739
fax: 202-767-6197 all files
baa instructions
may 26, 2015
open specific baaaward considerations
may 26, 2015
considerationsbaa introduction
may 26, 2015
introrepresentations and certifications
may 26, 2015
reps and certswhite paper and proposal preparation
may 26, 2015
preparationamendment 1
jun 09, 2015
n0017315rba01_amendm...download/view n0017315rba01_amendment_01.pdfgeneral information
notice type:
presolicitation
original posted date:
may 26, 2015
posted date:
june 16, 2015
response date:
jun 25, 2015 4:00 pm eastern
original response date:
jun 17, 2015 4:00 pm eastern
archiving policy:
manual archive
original archive date:
-
archive date:
-
original set aside:
n/a
set aside:
n/a
classification code:
a -- research & development
naics code:
541 -- professional, scientific, and technical services/541712 -- research and development in the physical, engineering, and life sciences (except biotechnology)
for help: federal service deskaccessibility
a -- research & development
naics code:
541 -- professional, scientific, and technical services/541712 -- research and development in the physical, engineering, and life sciences (except biotechnology)
541 -- professional, scientific, and technical services/541712 -- research and development in the physical, engineering, and life sciences (except biotechnology)
for help: federal service deskaccessibility
added: may 26, 2015 3:09 pm modified: jun 09, 2015 10:45 amtrack changes
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