Trinity Biotech Welcomes The Decision Of The High Court Of Kenya To Strike Out The Applications To Prevent the Procurement of TrinScreen HIV By The Kenyan Ministry of Health

DUBLIN, Ireland, Oct. 10, 2023 (GLOBE NEWSWIRE) — Trinity Biotech plc (Nasdaq: TRIB) (the “Company”), a leading developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets, welcomes the recent decision by the High Court of Kenya. The court has struck out both the interim application and the entire lawsuit filed by Gamma Zenith Kenya Limited against Trinity Biotech, Radiance Pharmaceutical, the Kenyan Ministry of Health, and the Kenyan Attorney General, that sought to prevent the Kenyan Ministry of Health’s procurement of TrinScreen HIV test kits. The High Court also discharged the interim orders that previously placed temporary restrictions on the procurement of TrinScreen HIV tests.

This court ruling marks a positive development for both public health in Kenya and Trinity Biotech. It signifies the removal of the legal barriers that had hindered the sale of TrinScreen HIV test kits to the Kenyan Ministry of Health. Consequently, Trinity Biotech is now able to proceed with supplying TrinScreen HIV in Kenya. Trinity Biotech expects to imminently receive TrinScreen HIV orders for the new Kenyan HIV rapid testing algorithm.

The Kenyan HIV screening programme is one of the largest in Africa, with an estimated annual number of screening tests of approximately 10 million.

A separate legal case against the Kenyan Ministry of Health and others, which challenged the new HIV rapid testing algorithm, was scheduled for a ruling on October 5, 2023. However, the ruling was not delivered as the trial judge was not available. The ruling will be delivered on notice, meaning that the court will issue its decision at a later date. It is important to highlight that, at present, the Company believes that there are no existing court orders that prohibit the Kenyan Ministry of Health from purchasing TrinScreen HIV test kits.

Forward-Looking Statements

Certain statements made in this release that are not historical are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words “estimate”, “project”, “intend”, “expect”, “believe” and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties. Many factors could cause the actual results, performance or achievements of Trinity Biotech to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements, including, but not limited to, the results of research and development efforts, risks associated with the outbreak and global spread of the coronavirus (COVID-19), the effect of regulation by the U.S. Food and Drug Administration and other agencies, the impact of competitive products, product development commercialization and technological difficulties. For additional information regarding these and other risks and uncertainties associated with Trinity Biotech’s business, reference is made to our reports filed from time to time with the U.S. Securities and Exchange Commission. 

About Trinity Biotech Plc

Trinity Biotech develops, acquires, manufactures and markets diagnostic systems, including both reagents and instrumentation, for the point-of-care and clinical laboratory segments of the diagnostic market. The products are used to detect infectious diseases and to quantify the level of Haemoglobin A1c and other chemistry parameters in serum, plasma and whole blood. Trinity Biotech sells direct in the United States, Germany, France and the U.K. and through a network of international distributors and strategic partners in over 75 countries worldwide. For further information, please see the Company’s website: www.trinitybiotech.com.