Development of CellRADx as a Tool for Dose Assessment and Triage ASELL is a leader in the development of in vitro diagnostics for biodosimetry. ASELL has been developing the CellRADx™ point-of-care biodosimetry diagnostic test in collaboration with the Armed Forces Radiobiology Research Institute (AFRRI) to increase national preparedness to respond to a mass-casualty [...]

Clinical Validation of a High-Throughput Biodosimetry Diagnostic Test ASELL is a leader in the development of in vitro diagnostics for biodosimetry. ASELL has been developing the CytoRADx™ System, a high-throughput biodosimetry diagnostic test, to increase national preparedness to respond to a mass-casualty radiological or nuclear incident. An essential requirement of this program is [...]

QSR Q&A: 5 Top Medtech Experts Answer 6 Burning Questions About FDA’s Coming Quality Reg Redo Medical device manufacturers and other industry stakeholders are waiting for the draft harmonized Quality System Regulation from the US Food and Drug Administration with breath that is bated. The agency has been working on the QSR redo – [...]

FDA and the Device Industry: Challenges in Working Together During the SARS-CoV-2 Pandemic It has become common these days to hear “We live in unprecedented times.” The medical device industry and FDA have been at the forefront of working to combat the SARS-CoV-2 virus, through the development and authorization of diagnostic tests, personal [...]

Regulatory and Practical Considerations for SARS-CoV-2 Direct Detection Test Developers IVD tests have two components of accuracy – sensitivity and specificity. Just as specificity is important for serology tests (https://asell.com/regulatory-considerations-for-sars-cov-2-serology-test-developers/), sensitivity is a key measurement of the effectiveness of a direct detection test. These values are typically obtained from a clinical study or method [...]

Regulatory Considerations for SARS-CoV-2 Serology Test Developers Given the considerable recent focus on serology assays for the detection of IgG and IgM antibodies to SARS-CoV-2, we wanted to highlight a few areas for consideration. Serology testing can, in theory, provide important information on the extent of the presence of antibodies to the virus in [...]