ASELL
Developer and integrator of diagnostic and medical device technologies focused on health security and emergency preparedness. Provides regulatory and quality systems support, clinical study execution, product development and government contracting services. Active in biodosimetry R&D and high-throughput assay implementation to support radiological/nuclear emergency response.
Industries
Nr. of Employees
small (1-50)
Products
Point-of-care biodosimetry triage diagnostic
Point-of-care diagnostic approach combining hematological measurements with triage algorithms to rapidly identify individuals needing further biodosimetry testing after radiological/nuclear incidents.
High-throughput automated cytogenetic biodosimetry system
Automated, high-throughput implementation of the cytokinesis-block micronucleus (CBMN) cytogenetic assay and associated reagents/kits to quantify absorbed radiation dose at scale for confirmatory testing.
CytoRADx
CytoRADx is an automated high-throughput cytogenetic biodosimetry and dose estimation system implementing the Cytokinesis Block Micronucleus (CBMN) assay for radiological incident response and clinical case management.
CellRADx
CellRADx Software Application can assess ionizing radiation exposure using a patient's CBC result from existing CBC instruments along with time post-exposure, age, and select medical conditions.
RADxScan
Automated slide scanning and analysis software used to obtain dose estimates from prepared biodosimetry slides.
Point-of-care biodosimetry triage diagnostic
Point-of-care diagnostic approach combining hematological measurements with triage algorithms to rapidly identify individuals needing further biodosimetry testing after radiological/nuclear incidents.
High-throughput automated cytogenetic biodosimetry system
Automated, high-throughput implementation of the cytokinesis-block micronucleus (CBMN) cytogenetic assay and associated reagents/kits to quantify absorbed radiation dose at scale for confirmatory testing.
CytoRADx
CytoRADx is an automated high-throughput cytogenetic biodosimetry and dose estimation system implementing the Cytokinesis Block Micronucleus (CBMN) assay for radiological incident response and clinical case management.
CellRADx
CellRADx Software Application can assess ionizing radiation exposure using a patient's CBC result from existing CBC instruments along with time post-exposure, age, and select medical conditions.
RADxScan
Automated slide scanning and analysis software used to obtain dose estimates from prepared biodosimetry slides.
Services
Regulatory strategy, submission preparation, and interactions with regulatory agencies for medical devices and IVDs.
Design and implementation of scaled QMS, SOP/manual development, QMS training and audit 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 reporting for diagnostics.
Roadmap development, program and risk management, partner/vendor coordination, and scientific advisory support throughout product lifecycle.
Identification of federal funding opportunities, capture planning, proposal development and execution of federally funded programs with FAR-compliant accounting practices.
Regulatory strategy, submission preparation, and interactions with regulatory agencies for medical devices and IVDs.
Design and implementation of scaled QMS, SOP/manual development, QMS training and audit 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 reporting for diagnostics.
Roadmap development, program and risk management, partner/vendor coordination, and scientific advisory support throughout product lifecycle.
Identification of federal funding opportunities, capture planning, proposal development and execution of federally funded programs with FAR-compliant accounting practices.
Expertise Areas
- Regulatory affairs and FDA submissions
- Quality management systems (FDA QSR, ISO 13485)
- Clinical trial design and execution for diagnostics
- Biodosimetry and cytogenetic assay development
Key Technologies
- Cytogenetic biodosimetry (CBMN assay automation)
- Molecular diagnostics (PCR/NAAT)
- Immunoassays
- Flow cytometry
News & Updates
Briefing on development of a triage biodosimetry test in collaboration with a federal radiobiology institute.
Presentation on analytical and clinical validation studies for a high-throughput cytogenetic biodosimetry system.
Presentation on qualitative and quantitative biodosimetry diagnostics for response planning to radiological/nuclear events.
Summarizes validation studies and presentation materials for a high-throughput cytogenetic biodosimetry system.
Discusses development of a point-of-care biodosimetry triage test and links to presentation materials.
Discussion of validation, EUA expectations, supply-chain considerations and alternative non-molecular detection approaches for SARS-CoV-2.
Briefing on development of a triage biodosimetry test in collaboration with a federal radiobiology institute.
Presentation on analytical and clinical validation studies for a high-throughput cytogenetic biodosimetry system.
Presentation on qualitative and quantitative biodosimetry diagnostics for response planning to radiological/nuclear events.
Summarizes validation studies and presentation materials for a high-throughput cytogenetic biodosimetry system.
Discusses development of a point-of-care biodosimetry triage test and links to presentation materials.
Discussion of validation, EUA expectations, supply-chain considerations and alternative non-molecular detection approaches for SARS-CoV-2.