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.”
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