DUBLIN, Ireland, May 20, 2022 (GLOBE NEWSWIRE) – Trinity Biotech plc (Nasdaq: TRIB) has obtained a CE mark for its 10-minute Covid-19 antigen test. This CE mark allows the use of healthcare professionals and trained users. The company intends to launch the test throughout the European Union as well as other countries that recognize the CE mark.
In addition to its ease of use and impressive speed that results in, the test in extensive clinical traces has shown excellent 99% sensitivity and 99% specificity, which are levels of accuracy that are superior to many of the tests currently on the market.
The test uses an anterior nasal graft instead of the more invasive nasopharangeal graft, providing a more comfortable patient experience. The test also has several user-friendly features, including a convenient pre-filled extraction buffer and a running time of 10 minutes, which is faster than many competing products. This speed of result and pre-filled buffer allows a higher throughput of patients for healthcare professionals and trained users performing the test, while providing a more comfortable patient experience without compromising on diagnostic performance.
In many cases, antigen testing has replaced PCR as the go-to method for Covid-19 testing, and we expect antigen testing to be an important tool for handling Covid-19 for many years to come.
The rapid Covid-19 antigen test was developed by Trinity Biotech on the same lateral flow test platform as the recently approved Trinscreen HIV ™ test by the World Health Organization (WHO) and will be manufactured at the company’s high volume automated lateral flow production site in Bray, Ireland.
The company will continue to investigate regulatory approval paths in other countries to decide which additional regulatory approvals to apply for this product.
The company intends to continue to expand its portfolio of rapid testing in the field of infectious diseases using the existing lateral flow testing platform and high-volume automated manufacturing.
Certain statements in this publication, which 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 terms aims to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties. Many factors may cause Trinity Biotech’s actual results, achievements or achievements to differ materially from future results, achievements 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 the global spread of coronavirus (COVID-19), the impact of regulation by the US Food and Drug Administration and other agencies, the impact of competitive products, the commercialization of product development, and technological difficulties. For more information about these and other risks and uncertainties associated with Trinity Biotech’s business, please refer to our reports submitted to the US Securities and Exchange Commission from time to time. We assume no obligation to update or revise any forward-looking statements for any reason.
About Trinity Biotech
Trinity Biotech develops, acquires, manufactures and markets diagnostic systems, including both reagents and instrumentation, for point-of-care and clinical laboratory segments in the diagnostic market. The products are used to detect infectious diseases and to quantify the level of hemoglobin A1c and other chemical parameters in serum, plasma and whole blood. Trinity Biotech sells directly in the United States, Germany, France and the United Kingdom and through a network of international distributors and strategic partners in over 75 countries worldwide. For further information see the company’s website: www.trinitybiotech.com.
|Contact:||Trinity Biotech plc
Email: [email protected]