Shares in diagnostic group Trinity Biotech jumped more than 10 per cent in the US yesterday after it announced that it had cleared the final regulatory hurdle to distribute its rapid test for HIV more widely.
The US Food and Drugs Administration (FDA) granted a waiver under the Clinical Laboratory Improvements Amendments (CLIA) of 1988 that will allow the the test to be used by a finger-stick procedure in doctor's offices or clinics. Until now, the test could be administered only through specially trained personnel in hospitals.
The HIV test designed by Trinity Biotech allows clinicians to get a result within 10 minutes.
The company, based in Bray, Co Wicklow, says it faces only one other competitor in the rapid test market for HIV in the key US market. However, it claims that its Uni-Gold product is twice as fast and more accurate.
Uni-Gold is the only rapid test for HIV that can be used to detect HIV antibodies in human serum, plasma, and blood drawn either from a vein or via a finger-stick.
The one-step process has been shown to be 100 per cent sensitive and 99.7 per cent specific.
Trinity Biotech chief executive Mr Ronan O'Caoimh praised the efforts of Trinity's workforce in reaching what he called a milestone. "We have cleared the final regulatory hurdle for our product," he said.
Trinity has had a 90-strong team marketing and selling the test to hospitals in the United States since it won initial FDA approval last December.
"With the finger stick approval and CLIA waiver, this group will now turn its focus on to the significantly larger public health and physician's office market segments," said Mr O'Caoimh in a statement last night. "We are excited at the prospect of what this means for Trinity Biotech's future growth."
The latest approval opens up almost 200,000 potential new testing centres for the product, which has already been marketed in sub-Saharan Africa.
Last September, Trinity said the test had accounted for $6 million (€4.65 million) in its worldwide sales for the year to date. The company will hope for a sharp increase with the wider availability of the procedure. It had 2003 sales of $65.7 million.
Shares in Trinity closed more than 14 cent up in the US last night on $2.99. However, the stock is still well short of the $6.72 mark it hit in the immediate aftermath of the initial FDA approval last December.
