Posted: 6 October 2023
Universal Biosensors, Inc. (ASX: UBI) is pleased to announce it has received the approval required for the sale of “Xprecia Prime 4U” directly to patients for self-testing in Europe.
The approval is in the form of the EU Technical Documentation Assessment Certificate (IVDR) issued pursuant to Regulation (EU) 2017/746 on in vitro diagnostic medical devices (Class C) for Patient Self-Testing/near patient testing, issued by Notified Body -TÜV SÜD Product Service GmbH.
Mr John Sharman, CEO of UBI said; “We have been working on the development and approval of the new Xprecia Prime 4U device for more than 18 months and this approval is an important step towards building a meaningful Xprecia business in Europe.
“The Patient Self-Testing market is the fastest growing PT/INR market in Europe and when combined with the use of PT/INR devices and test strips in hospitals and clinic, we estimate
the market is worth $365m pa. More importantly, many of the hospitals and governments will only award tender ’wins’ to products that have the approval for patients to take the device home and test themselves. This approval is therefore very important for the future sales growth of our Xprecia products in Europe.”
