News and Announcements
Development Update UBI PT-INR Testing System
- Published October 15, 2015 11:36AM UTC
- Publisher Wholesale Investor
- Categories Company Updates
15th October 2015, ASX Announcement
Universal Biosensors, Inc. (ASX: UBI) today provided the following development update with respect to its own PT-INR testing system to be used in decentralised settings (e.g. doctor’s offices and the home).
The Company is currently undertaking a program of product reliability and performance testing to verify that the system is ready for clinical trials and usability studies.
At the same time it is finalising arrangements with clinical sites in preparation for the start of regulatory clinical trials.
As soon as sufficient clinical data has been collected to demonstrate performance across an appropriate patient population, the Company will be in a position to see CE Mark self-certification and approve the product for initial European release. It is anticipated that this will now occur in the first half of 2016, noting that the majority of the costs of associated product development are expected to be incurred before the end of 2015.
To read the full announcement, please click here.
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