UNIVERSAL BIOSENSORS SHARES SURGE AFTER FDA APPROVAL

UNIVERSAL Biosensors (ASX:UBI) is trading up 16.95 per cent today following the US Food and Drug Administration's approval of Siemens Healthineers' Xprecia Stride Coagulation Analyzer.

The hand-held device uses test strips developed and manufactured by UBI at its Rowville facility, in Victoria, to help monitor and assess patients taking the anticoagulation drug warfarin.

Warfarin is a blood thinner and its use must be monitored carefully, as too much of the drug can lead to uncontrolled bleeding, while too little can lead to a blood clot.

The worldwide point-of-care market for coagulation testing was estimated to be worth around US$1 billion in 2014 and is forecast to grow 9 per cent per annum to $US1.4 billion by 2018.

UBI executive chairman Andrew Denver says he is thrilled patients in the US will have access to this "exceptional" device.

"We look forward to working with Siemens to help establish its place in the US market," says Denver.

The Xprecia Stride analyser was commercially launched in Europe in May 2015.

Universal Biosensors released its results for the first half of 2016 in late July, and they showed a 41 per cent growth in revenue to $10.5 million compared to the previous corresponding period.

However, revenue from sales of the Xprecia Stride Coagulation Analyzer were down 56 per cent on the pcp.

The company gets most of its revenue from its partnership with LifeScan, for which it provides its One Touch Verio blood glucose test strips.

Overall, the company made a loss of $1.2 million in the first half of this year.