Global electrochemical cell technology company, Universal Biosensors (ASX:UBI) shares have surged 60% following the attainment of US Food and Drug Administration (FDA) and Clinical Laboratory Improvement Amendments (CLIA) Waiver approvals for its, Xprecia Prime Coagulation Analyser, classified as a Class II device.
“Approval to sell Xprecia Prime in the USA is a historic moment for UBI. It represents more than 10 years of research & development work and many millions of dollars of investment,” UBI CEO John Sharman said.
“This is the first time the FDA has granted a CLIA Waiver by Application to any coagulation device, and it is testament to the performance of Xprecia Prime.”
The approval allows UBI to market the Xprecia Prime across various healthcare professional settings, including CLIA waived facilities such as hospitals, clinics, and doctor’s offices throughout the USA.
These approvals cover the full measuring range of 0.8 – 8.0 International Normalised Ratio (INR) for the Waiver applications, validating the device’s efficacy and compliance.
“The number of PT/INR tests performed in clinics is the largest part of the USA market, so to have won unrestricted access to all clinics and hospitals across the USA is a major achievement,”
“There are more than 6 million patients who take warfarin (coumadin) in the USA and more than 140 million PT/INR test strips are sold each year.” Mr Sharman said.
This FDA approval marks the first opportunity in UBI’s history to access the profitable and fully reimbursed USA market.
UBI last traded at 25 cents, at 11 am AEDT.