Trinity Biotech invites all our partners visit us at our booth Z6. D41
Trinity Biotech plc. (Nasdaq: TRIB) today announced that a CLIA waiver has been received for Syphilis Health Check –a point-of-care rapid test for the detection of Syphilis which is distributed by Trinity Biotech in the USA. CLIA waiver has been granted by the U.S. Food and Drug Administration (FDA) to Syphilis Health Check, which is the first ever waiver for a rapid screening test for syphilis available in the United States. Importantly, the waiver allows the test to be performed by untrained healthcare workers in a variety of non-traditional laboratory sites such as emergency rooms, health department clinics, community-based organisations, physicians’ offices and other free standing counselling and testing locations.
Syphilis Health Check is a qualitative rapid membrane immune-chromatographic assay for the detection of Treponema pallidum(Syphilis) antibodies in human whole blood, serum and plasma. The test, which acts as a screening test, will primarily be performed in a CLIA waived setting using finger stick samples of whole blood only, with results being available in as little as 12 minutes.
All positive tests should be followed up with further syphilis serological laboratory testing and clinical evaluation before final diagnosis. Syphilis has been identified as a growing disease in the USA. According to the Centers for Disease Control and Prevention (CDC) there are approximately 55,000 new cases of primary and secondary syphilis in the USA each year. This growth is particularly prevalent amongst men who have sex with men (MSM), who now account for more than 75% of all new cases, with an increasing number occurring in the 15 to 24 age bracket. Early detection and treatment is central to limiting the spread of the disease and should help to reduce the risk of additional health issues in those who contract it.
William Smith, Executive Director of the National Coalition of STD Directors (NCSD) which represents state and local STD public health programs across the country commented, “NCSD has been working and advocating for years to bring this product to the wider marketplace that a CLIA waiver makes possible. We have done so because we have a public health emergency on our hands when it comes to increases in syphilis rates and now we have a point-of-care screening device that allows for timely and accurate test results to intervene sooner in people who are infected. It’s a game changer and we are excited to get this test out into our member health department programs.”
Commenting on today’s news, Ronan O’Caoimh, CEO of Trinity Biotech, said “We are delighted that Syphilis Health Check has been CLIA waived. This is the only CLIA waived syphilis test now available in the USA and will become a major platform in combating the spread of syphilis, which has been increasing at an alarming rate over recent years. Early detection has been identified as a key step in this battle and this waiver now provides broader availability and easier access which should contribute to a higher rate of detection. Prior to the granting of this waiver there was no product for rapid syphilis screening testing in the USA. In addition, this test should act as an excellent companion product for our Uni-Gold™ rapid HIV test which itself is CLIA waived and services a similar patient demographic.”
Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements involve risks and uncertainties including, but not limited to, the results of research and development efforts, the effect of regulation by the United States Food and Drug Administration and other agencies, the impact of competitive products, product development commercialisation and technological difficulties, and other risks detailed in the Company’s periodic reports filed with the Securities and Exchange Commission.
Trinity Biotech plc. (Nasdaq: TRIB), today announced it has obtained the CE mark (i.e. European approval) for its Meritas point-of-care BNP test.
Heart failure, also referred to as chronic or congestive heart failure, is a complex progressive syndrome that impacts about 26 million people worldwide with almost 700,000 new cases diagnosed each year in the United States alone. Heart failure is a serious condition in which the heart cannot pump enough blood to meet the needs of the body. Although often life threatening, the typical symptoms of heart failure (breathlessness, fatigue and swelling of the limbs) are usually less dramatic than those associated with a heart attack. In economically developed countries, up to one in five people are expected to develop heart failure at some point in their life. As the symptoms of heart failure are variable and non-specific, blood-based biomarkers are frequently used to assist in the difficult diagnosis of heart failure.
Brain or B-type natriuretic peptide (BNP) levels in the bloodstream increase as the severity of heart disease proceeds. Thus, BNP has emerged as the principal biomarker in aiding the diagnosis of and determining the clinical severity of acute and chronic heart failure. In addition, BNP can be useful in a wide range of clinical applications including risk stratification and monitoring of patients with heart failure and heart attacks. The Meritas BNP test demonstrates exceptional sensitivity and precision, which is at least comparable to much larger and far more expensive central laboratory systems, while delivering results in ten minutes, right at the point-of-care. Existing competitive BNP tests have certain limitations due to the effects of sample degradation. This makes those tests challenging to use in primary care and in retrospective studies, where sample degradation may falsely lower test results. Due to its design the new patented Meritas BNP test is not hindered by these limitations.
Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements involve risks and uncertainties including, but not limited to, the results of research and development efforts, the effect of regulation by the United States Food and Drug Administration and other agencies, the impact of competitive products, product development commercialisation and technological difficulties, and other risks detailed in the Company’s periodic reports filed with the Securities and Exchange Commission.
Trinity Biotech plc announces the CE marking of our new Uni-Gold™ H. pylori Antigen point-of-care test. The Uni-Gold™ H. pylori Antigen is a 15 min rapid test, used to aid in the diagnosis of Helicobacter pylori (H. pylori) infection and to monitor the effectiveness of treatment.
The launch of the Uni-Gold™ H. pylori Antigen test will complement our existing range of Uni-Gold™ tests for enteric diseases.
Helicobacter pylori (H. pylori) is a bacterium, found in either the stomach, duodenum or hepatobiliary tract. H. pylori is an important cause of gastritis and peptic ulcers. Infection with H. pylori is the cause of most stomach and duodenal ulcers and is a major risk factor for gastric cancer. About 10-20% of people who are infected with H. pylori develop an ulcer and have a 1-2% risk of stomach cancer.