N0017315RBA01_Amendment_02.pdf

Solicitation No.: N00173-15-R-BA01

Amendment 0002

Whereas the Naval Research Laboratory Contracting Officer received questions from potential offerors, the purpose of this amendment is to provide answers to questions received.

Q1. Can you clarify again the requirements for Tier 1. If multiplexed assay completed at

TRL4 level is not a requirement at the end of Tier 1, do the biomarkers suggested as a multiplex for this BAA need to be at TRL4 as singleplex?

A1) Tier 1 evaluation, performed by NRL staff, will be with the technology at its current state. At the time of white paper submission, there is no specific characteristic of the assay or device that must meet TRL4 to be considered. However, evaluation of the white paper will include an assessment of the technology's maturity, technical capabilities not yet demonstrated, the plan and time needed for development, and cost realism to advance from its current state to the final performance characteristics.

Q2. Since your answer (Q1-A1) in the June 9 amendment states that “for Tier 1 it could be acceptable to demonstrate the technology's performance with a disease not listed in the Broad

Area Announcement, for example influenza”, does the whole purpose of Tier 1 is to access the suitability of the technology proposed? If that is the case, can all the biomarkers planned for the multiplex be introduced and researched in Tier 2? Does the assay need to be at TRL4 at the end of Tier 2?

A2) Yes, the purpose of Tier 1 is to evaluate the suitability of the proposed technology.

Yes, it is acceptable for all assays on the multiplex to be introduced in Tier 2. The technology would need to be at minimum TRL5 by the end of Tier 2; note that: (1) the technology must demonstrate sufficient analytical sensitivity, specificity and total

(positive and negative) predictive value for infectious disease diagnostic applications and

(2) be capable of detection from whole blood.

Q3. Can you clarify the statement “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”? Is it directed towards genomic analysis platforms or is it also for immune-analysis platforms like lateral-Flow?

A3) The BAA seeks both immunoassay and genomic assay technologies. In either case, the offeror must explain how they envision the work flow progressing from sample collection through diagnostic answer. Please remember that in Tier 3, the proposed technology is intended for use in field forward settings with febrile subjects.

Q4. If automation is a requirement for immune-analysis platforms, can the modification to the assay to be able to automate be introduced in Tier 2 along with research needed for multiplexing

(with all proposed biomarkers) while Tier 1 work is only directed to show the suitability of the non-automated assay platform?

Solicitation No.: N00173-15-R-BA01

Amendment 0002

A4) Yes, automation of assay performance, sample prep, etc. are suitable Tier 2 activities. Yes, assay multiplexing is a suitable Tier 2 activity.

Q5. We are in the process of preparing our budget to stand-alone subsets of efforts. However as we do so for Tier 1, we are hoping to obtain more information on the benchmarking to be performed. Will benchmarking be a review of the Design history file and or technical file for the platform/proposed product, i.e. a document review? Or will our teams be delivering product for functional assessment during Tier 1?

A5) Tier 1 will be a functional assessment of the assay and/or device platform delivered to NRL.

End of Amendment 0002.