Medical tech firm Universal Biosensors (ASX:UBI) has submitted an application to the US Food and Drug Administration for approval of its Xprecia Prime blood clot screening product for use in the US.
The company has spent over a decade developing its Point-of-Care coagulation platform and the centrepiece of the application is the 360 patient study to provide evidence of Xprecia Prime.
Universal Biosensors Chief Executive John Sharman said he hoped a positive result would "add significant value to our coagulation business into the future".
Following the announcement, shares of Universal Biosensors were down 2%.