In November 2010, a productmanager from Beckman Coulter Diagnostics said:
“…this NGAL assay is not yet CE marked as an IVD parameter and until such regulatory approval is granted, Beckman Coulter cannot recommend the assay to our customers. However, individual customers may buy NGAL direct from BioPorto for use on the AU platforms, using the stated parameters.”
And:
“NGAL is on our list of tests of interest for future development, however, as yet there is no funded project to deliver a NGAL test on a Beckman Coulter platform. As such, I would not anticipate the test being available within the next 24 months.”
As we know now, “The NGAL Test” got the CE mark in the first days of 2011.
But that is all we know for now.
