The latest headlines on diagnostics regulation: FDA, CMS, and international regulatory agencies.
Theassay is designed for the rapid qualitative detection of platelet factor 4-heparin complex IgG antibodies associated with heparin-induced thrombocytopenia.
Participants shared data from head-to-head assay comparisons, reflected on the advancement of NGS and digital PCR methods, and discussed new standardization projects.
The FDA cited Euro Diagnostica for at least five violations stemming from an inspection of its facility in January, as well as inadequate responses to those violations.
The firm is now in talks with commercialization and distribution partners to make the test widely available in Europe and other markets that recognize the CE mark.
OIG will evaluate data to assess whether PAMA pricing results in market-based rates