ASELL LLC
ASELL is a product and solutions development and consulting firm focused on medical device and in vitro diagnostic development for health security and emergency preparedness. The company provides regulatory strategy and submission support, quality management system implementation, clinical research and validation services, product development and program management, and government contracting expertise. ASELL also develops biodosimetry diagnostic tools and automated high-throughput cytogenetic assays to support response to radiological/nuclear incidents.
Industries
N/A
Nr. of Employees
small (1-50)
ASELL LLC
Products
CellRADx (triage biodosimetry system)
A triage biodosimetry approach that uses hematological data and biodosimetry algorithms to provide early diagnostic information to support rapid triage after radiological/nuclear incidents.
CytoRADx (confirmatory high-throughput biodosimetry)
A high-throughput implementation of the cytokinesis-block micronucleus (CBMN) cytogenetic assay that automates and optimizes assay workflows and biomarkers to enable quantitative biodosimetry at scale for use in clinical laboratories.
CellRADx (triage biodosimetry system)
A triage biodosimetry approach that uses hematological data and biodosimetry algorithms to provide early diagnostic information to support rapid triage after radiological/nuclear incidents.
CytoRADx (confirmatory high-throughput biodosimetry)
A high-throughput implementation of the cytokinesis-block micronucleus (CBMN) cytogenetic assay that automates and optimizes assay workflows and biomarkers to enable quantitative biodosimetry at scale for use in clinical laboratories.
Services
Regulatory strategy development, pre-submission and submission preparation, and FDA engagement support for EUA, Breakthrough Device, 510(k), de novo, and PMA pathways.
Design and implementation of QMS scaled to the organization, development of quality manuals and SOPs, QMS training, and audit preparation/support aligned to FDA QSR and ISO 13485.
Clinical study project management, protocol development, IRB submissions, site and lab management, data management, usability testing, and clinical performance testing from feasibility through validation.
Product roadmap and development planning, program and risk management, partner and vendor management, and scientific advisory support throughout device development.
Identification of federal funding targets, capture planning, proposal development, federal subcontracting, FAR-compliant accounting, and earned value management for federally funded programs.
Regulatory strategy development, pre-submission and submission preparation, and FDA engagement support for EUA, Breakthrough Device, 510(k), de novo, and PMA pathways.
Design and implementation of QMS scaled to the organization, development of quality manuals and SOPs, QMS training, and audit preparation/support aligned to FDA QSR and ISO 13485.
Clinical study project management, protocol development, IRB submissions, site and lab management, data management, usability testing, and clinical performance testing from feasibility through validation.
Product roadmap and development planning, program and risk management, partner and vendor management, and scientific advisory support throughout device development.
Identification of federal funding targets, capture planning, proposal development, federal subcontracting, FAR-compliant accounting, and earned value management for federally funded programs.
Expertise Areas
- Regulatory compliance and submission strategy for medical devices and IVDs
- Quality management systems (FDA QSR and ISO 13485)
- Clinical trial management and diagnostic validation
- Biodosimetry and cytogenetic assay development
Key Technologies
- Cytokinesis-block micronucleus (CBMN) cytogenetic assay
- High-throughput assay automation
- Biodosimetry algorithms and hematological analytics
- Molecular diagnostics (PCR and related amplification methods)
News & Updates
Summary of analytical and clinical validation studies presented for a high-throughput cytogenetic biodosimetry system and a link to the presentation detailing validation work.
Presentation and summary describing triage and confirmatory biodosimetry diagnostic tools and how they integrate with radiological/nuclear emergency response frameworks; includes a downloadable presentation.
Commentary on interactions between FDA and the medical device/IVD industry during the COVID-19 pandemic, with focus on EUA processes and impacts on regulatory workflows.
Summary of analytical and clinical validation studies presented for a high-throughput cytogenetic biodosimetry system and a link to the presentation detailing validation work.
Presentation and summary describing triage and confirmatory biodosimetry diagnostic tools and how they integrate with radiological/nuclear emergency response frameworks; includes a downloadable presentation.
Commentary on interactions between FDA and the medical device/IVD industry during the COVID-19 pandemic, with focus on EUA processes and impacts on regulatory workflows.