| 7.2 |
Biothreat Agent Diagnostics: Biothreat Agents of Interest include (listed alphabetically): Bacillus anthracis (anthrax), botulinum neurotoxin (botulism), Burkholderia mallei (glanders) and Burkholderia pseudomallei (melioidosis), ebolaviruses and Marburg virus, Francisella tularensis (tularemia), Rickettsia prowazekii (epidemic typhus), Yersinia pestis (plague), and smallpox (orthopox genus virus assays acceptable). |
| 7.2.1 |
Advanced development, clinical evaluation, and FDA clearance/approval of rapid, accurate POC diagnostic systems for biothreats defined above |
| 7.2.2 |
Advanced development, clinical evaluation, and FDA clearance of automated, high-throughput diagnostic assays for determining infection due to the biothreats defined above |
| 7.3 |
Antibiotic Resistance Diagnostics for priority bacterial pathogens |
| 7.3.1 |
Advanced development, clinical evaluation, and FDA clearance/approval of direct specimen diagnostic tests to guide targeted therapeutic decisions for priority bacterial pathogens by identifying the pathogen(s) and their resistance or susceptibility to relevant antibiotics without additional sample preparation. |
| 7.3.2 |
Advanced development, clinical evaluation and FDA clearance/approval of CLIA waivable/waived, rapid platforms and assays for use in POC settings that will reliably distinguish between Viral and Bacterial infections in order to inform appropriate use of antibacterials and antivirals |
| 7.3.3 |
Advanced development, clinical evaluation and FDA clearance/approval of multiplex molecular assays for use in moderate complexity and high complexity laboratory settings that identify priority bacterial pathogens and genetic determinants of antibiotic resistance in a single direct specimen analysis |
| 7.3.4 |
Advanced development and clinical evaluation of POC tests to enable antibiotic clinical trials, i.e., rapidly rule in/rule out pathogen of interest, and assess resistance profile from clinical specimens |
| 7.3.5 |
Advanced development, clinical evaluation, and FDA clearance/approval of clinically applicable specimen-to-result sequencing solutions with user-friendly simplified workflow and bioinformatics tools appropriate for use in a clinical diagnostics laboratory to identify pathogens with known and novel resistance determinants directly from a broad range of clinical specimen types |
| 7.3.6 |
Advanced development, clinical evaluation, and FDA clearance/approval of novel phenotypic susceptibility platforms and assays for use in moderate and high complexity laboratory settings that will shorten the time required to reliably and accurately identify resistance or susceptibility to relevant antibiotics |
| 7.4 |
Radiation Exposure (Biodosimetry) Diagnostics |
| 7.4.1 |
Development of a dosimetry self-assessment tool in order to determine if an individual (adults and children) has absorbed ionizing radiation at a dose equal to or greater than 2 Gy |
| 7.6 |
Influenza Diagnostics |
| 7.6.1 |
Advanced development, clinical evaluation and FDA clearance/approval of home-use tests that detect influenza, and, at a minimum, differentiate Influenza A and B viruses |
| 7.6.2 |
Advanced development, clinical evaluation, and FDA clearance/approval of methods to enable more rapid identification of novel influenza viruses, human-animal reassortant influenza viruses, or emerging respiratory viruses with the goal to identify and diagnose both seasonal and novel influenza infections |
| 7.8 |
Sequencing System Development |
| 7.8.1 |
Advanced development of simplified, next generation sequencing platforms and analysis tools, making them more suitable for use in CLIA regulated laboratories |
