DIGET_BAA Attachment 2_Specific_Program_Plan_Template FINAL.xlsx

XLSX spreadsheet 13 KB Posted

Attached to
Detect It with Gene Editing Technologies (DIGET) Federal contract opportunity
Solicitation number
HR001120S0016
Issued by
Defense Advanced Research Projects Agency

About this file

This document provides guidance for completing a Specific Program Plan template to support proposals submitted in response to the Defense Advanced Research Projects Agency's Detect It with Gene Editing Technologies broad agency announcement. The Specific Program Plan template requests concise answers about assay and device details, goals, validation and demonstration plans for Phases 1 and 2. Proposals should address detection assays for specific pathogens or biomarkers from various sample types using computational design and internal validation approaches. Phase 1 goals include limits of detection, sensitivity, specificity, multiplex capability, and time to result. Device details incorporate sample preparation, throughput, and detection methods. Integration plans and internal validation processes are also summarized. Proposals must include engagement plans with verification and validation partners for shipping samples and receiving feedback.

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Text version

SPP

Guidance for completing the DIGET Specific Program Plan (SPP):

--Provide key proposal details already described in the full proposal. (Replace existing text below with answers.)

--Provide concise (no more than1-3 sentence answers) to each Program Detail requested. (Some answers may be redundant.)

--Submit in excel format.

PhaseTopicProgram Detail
1TA1 (Detection Assay Design and Development)Assay summary: targets (specific pathogens, biomarkers, etc.), sample types, enzyme, reporter system
1Computational design strategy (e.g., software pipeline used, approach, COTS or custom-built, ML/AI tools, design validation)
1Summary (1-3 sentences) of Internal assay validation plan (e.g., how will assays be tested and evaluated by performer, what is necessary for an assay to pass or be marked for revision)
1Phase 1 Assay goals: Limit of detection, Sensitivity, Specificity, Multiplex, Time (sample to answer)
1Expected performance compared to "gold standard" methods (e.g., x more sensitive than..., x faster than…, x lower LOD than...)
1TA2 (Device Development and Deployment)MMD summary: sample prep, sample throughput (per run, per day, etc.), detection method, analysis algorithm method, result readout
1MMD Phase 1 goals: Limit of detection, Sensitivity, Specificity, Multiplex, Time (sample to answer), Manufacturing
1MMD: Summary (1-3 sentences) of plan to build into current biosurveillance networks
1MMD: Expected Phase 1 performance compared to "gold standard" methods (e.g., x more sensitive than..., x faster than…, x lower LOD than...)
1Point-of-Need summary:sample prep, sample throughput (per run, per day, etc.), detection method, result readout
1Point-of-Need Phase 1 goals: Limit of detection, Sensitivity, Specificity, Multiplex, Time (sample to answer), Manufacturing
1Point-of-Need: Expected Phase 1 performance compared to "gold standard" methods (e.g., x more sensitive than..., x faster than…, x lower LOD than...)
1Capability Demonstration 1Demo summary (1-3 sentences): targets, samples, method of testing
2Integrated PlatformIntegration plan summary (1-3 sentences)
2Summary (1-3 sentences) of internal platform validation plan (e.g., how will platforms be tested and evaluated by performer, what is necessary for a platform to pass or be marked for revision)
2MMD summary: sample prep, sample throughput (per run, per day, etc.), detection method, analysis algorithm method, result readout
2MMD Phase 2 goals: Limit of detection, Sensitivity, Specificity, Multiplex, Time (sample to answer), Manufacturing, SWAP, ruggedness, stability
MMD: Expected Phase 2 performance compared to "gold standard" methods (e.g., x more sensitive than..., x faster than…, x lower LOD than...)
2Point-of-Need summary:sample prep, sample throughput (per run, per day, etc.), detection method, result readout
2Point-of-Need Phase 2 goals: Limit of detection, Sensitivity, Specificity, Multiplex, Time (sample to answer), Manufacturing, SWAP, ruggedness, stability
2Point-of-Need: Expected Phase 2 performance compared to "gold standard" methods (e.g., x more sensitive than..., x faster than…, x lower LOD than...)
2Capability Demonstration 2Demo summary (1-3 sentences): targets, samples, method of testing
2FDA SubmissionSummary (1-3 sentences) of steps and timing for successful FDA submission (e.g., IDE, 510(k), etc)
1+2IV&V engagementSummary of planned engagment with IV&V partners, plans for shipping devices/samples, receiving samples, training materials, etc

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