Trinity Biotech plc has received approval for its new HIV screening product, TrinScreen™ HIV, from the World Health Organisation (WHO). Trinity Biotech's Uni-Gold™ HIV product has been the main confirmatory test provider for the detection of the HIV virus on the African continent over many years. Trinity Biotech has developed this new product, TrinScreen™ HIV, specifically for the screening market, a market that is significantly larger than the confirmatory market, with an estimated market size of over USD 150 million.

TrinScreen™ HIV is a rapid test providing results in less than 12 minutes from a finger stick drop of blood and the test has demonstrated excellent performance in both an independent evaluation sponsored by the WHO and in a multi-centre clinical evaluation conducted in Africa in 2020 by the Company. The Company believes the TrinScreen™ HIV product has a number of key advantages compared to the current main incumbent product. Having been the main confirmatory test provider for the detection of HIV in Africa over many years, the Company has strong relationships with key opinion leaders in this area as well as with the Non-Government Organisationswho fund HIV testing in Africa.

In anticipation of the WHO approval of TrinScreen™ HIV, the Company has expanded the sales and marketing team serving the African continent through the appointment of senior and experienced sales executives with a demonstrated track record in the HIV market. This WHO approval coupled with the excellent product performance, Trinity Biotech's brand equity and an experienced sales and marketing team should allow Trinity Biotech to expedite the adoption of Trinscreen™ HIV into recurring multi-year national screening algorithms across Africa and as a result, the Company expects to capture a significant share of the HIV screening market in Africa. Opportunities also exist for TrinScreen™ HIV in emerging countries on other continents.

The Company will manufacture TrinScreen™ HIV at its automated manufacturing plant in Bray, Ireland.