Rockeby lines up diagnostics for FDA approval
Monday, 20 September, 2004
Rockeby biomed (ASX: RBY) has lodged a 501(k) submission for regulatory approval of its systemic candidiasis diagnostic SysCan3 with the United States Food and Drug Administration.
The submission is based on data from a recent 5 centre, 200 patient clinical trial in the United States.
This data will also be used to support a second 501(k) submission for Rockeby's CanDia5 point of care diagnostic for vaginal thrush, expected later this week.
The 501(k) process -- under which the FDA determines whether the device is equivalent to devices which have already been classified -- is a much faster process than FDA approval for drugs and other pharmaceuticals and in some circumstances may take as little as 90 days from the lodgment date.
Proposed Australian trial eyes up blood testing for Alzheimer's
Utilising networks of GPs across three states, a large-scale study intends on combining digital...
Applications open for $300K pandemic therapeutics fellowships
Applications are now open for the Cumming Global Centre for Pandemic Therapeutics' inaugural...
CTA granted for CAR-T cell therapy for multiple myeloma
The Therapeutic Goods Administration has granted Clinical Trial Approval for KMCAR T-cell...
