FDA clears Inova's Luminex-based diagnostic kit:
This article was originally published in Clinica
Executive Summary
Inova Diagnostics has gained US FDA 510(k) marketing clearance for an immunoassay that can simultaneously measure four of the most common autoantibodies - Sm, RNP, SS-A and SS-B - found in systemic autoimmune disorders. The QUANTA Plex ENA Profile 4 is based on a testing technology, called LabMAP, developed by Luminex. LabMAP, which is also cleared in the US, combines microsphere-based assays with small lasers, advanced digital signal processors and software to offer greater speed, precision and flexibility over current bioassay technologies, Inova claims. The San Diego, California firm says it plans to expand its QUANTA Plex product line. It will pay Luminex a royalty based on sales of their LabMAP-based products.
You may also be interested in...
EU’s SCCS Finds Endocrine-Disrupting Evidence Inconclusive In UV Filter Reassessments
While endocrine-disrupting evidence was inconclusive, the Scientific Committee on Consumer Safety recommends more conservative limits on use of homosalate, octocrylene and benzophenone-3 in cosmetic products compared with current requirements under the European Cosmetics Product Regulation.
US FDA Urges COVID-19 Transmission Risk Mitigation In Cell And Gene Therapy Manufacturing
The risk of inadvertently growing SARS-CoV-2 virus in cell and gene therapies and possibly infecting patients and workers should be assessed and mitigated, the agency advises.
COVID-19: US Acted To Beat Other Countries To Next 1.25M Doses Of Regeneron Cocktail
Move was meant to preempt others’ efforts to secure the next six months of Regeneron’s COVID-19 antibody therapeutic.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: