I've yet to see any headway with FDA approval for either the Ellume:lab (not really a lab but a Dr clinic based test) or iTreat tests systems. In fact the majors seem to be running blocking interference with FDA, demanding self tests be as accurate as lab ones - further stirred along by deaths after false negative & positives from some existing "Rapid" clinic based tests. However at the recent Ausbiotech event, Anteo's ex and now current Head of Quality at Ellume Shaun Cooper and TGA’s Steve Dunlop, (Director, Regulatory Guidance) were copresenters and offering SME Support. Asian regulators are less transparent but Ellume hinted at regional direction so most probably are working on approval paths there.
They do say on their web site:
"Currently health care professionals can test for Group A Streptococcus. Test for future release include Influenza A/B, Chlamydia trachomatis, Respiratory Syncytial Virus (RSV), D-Dimer, C-Reactive Protein (CRP)." - this would be for the Ellume:lab but maybe iTreat too. The difference maybe subject to potential markets & regulations.
Here is a picture of test strips which confirms the test modules exist. Zoom the colourful thingys for test nomenclature.
Are Anteo & Ellume collaborating on all of these? Well in 28-Oct-2016 annc, Tamara noted "Other pipeline products include
Respiratory Syncytial Virus, Group A Streptococcus and Chlamydia." Note: A Strep clinical trial was running concurrent with the recent FluA/B trial.
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