Trinity gets approval for HIV test

Trinity Biotech plc today announced that the US Food and Drug Administration (FDA) has approved a waiver for the Uni-Gold Recombigen HIV test.

The test is approved by the FDA for the detection of antibodies to HIV in human serum, plasma, venous and finger stick whole blood and is the only Rapid HIV Test to be approved for use with all four sample types.

The product, the company says, is easy to use, requires one-step and produces a result within 10 minutes.

The test is highly accurate being 100% sensitive and 99.7% specific.

The waiver means that the test can be used by almost 200,000 test sites including physician’s offices and clinics in addition to its previously-approved applicability in the hospital environment.

The waiver is necessary to address the public health market segment which is estimated to be three times the size of the hospital laboratory market.

Trinity Biotech’s CEO Ronan Ó Caoimh said: “With the receipt of the CLIA waiver for use of Uni-Gold HIV with finger stick whole blood, we have now completed the final regulatory hurdle for our product.

“During 2004 our 90-strong sales and marketing team in the United States launched Uni-Gold HIV in the hospital market and with the finger stick approval and CLIA waiver, this group will now also turn its focus on to the significantly larger public health and physician’s office market segments.

“We are excited at the prospect of what this means for Trinity Biotech’s future growth and know that our successful experience of marketing the product in sub-Saharan Africa can be applied to the US market.”

Trinity Biotech develops, acquires, manufactures and markets over 500 diagnostic products for the point-of-care and clinical laboratory segments of the diagnostic market.

Trinity’s shares on the ISEQ were steady at €2.20 at lunchtime today.