OXFORD, United Kingdom and MARLBOROUGH, Mass., May 17, 2019 (GLOBE NEWSWIRE) -- Oxford Immunotec Global PLC (Nasdaq:OXFD) (the "Company"), a global, high-growth diagnostics company, today announced that it welcomes the updated Tuberculosis Screening, Testing, and Treatment of U.S. Health Care Personnel: Recommendations from the National Tuberculosis Controllers Association and CDC, 2019, published by the U.S. Centers for Disease Control and Prevention (CDC)1. These guidelines increase the focus on eradicating tuberculosis (TB) disease in the United States through an individual risk-based approach to screening and treatment for Healthcare Personnel (HCP).
Key highlights from the updated guidelines include:
- Recommendation for TB Screening and Individual Based TB Risk Assessment on Hire: continue baseline screening of all HCPs upon hire with the addition of an individual risk assessment
- Recommendation to Focus Serial Testing on Higher Risk Individuals: decision to perform TB testing after baseline based on HCP's risk for TB exposure at work or elsewhere
- Recommendation for Latent Tuberculosis Infection (LTBI)Treatment: treatment, including short-course therapy, is now strongly recommended for all HCPs diagnosed with LTBI
"We are pleased to see increased focus on preventative screening and treatment for LTBI," said Dr. Peter Wrighton-Smith, CEO of Oxford Immunotec. "These updated recommendations underscore the need to treat LTBI in order to eradicate active TB. We expect these guidelines to further the trend toward IGRA adoption for healthcare personnel screening due to high test accuracy and reduced number of patient visits."
There are currently two types of tests available for TB screening in the US, the tuberculin skin test (TST) and interferon gamma release assays (IGRAs). The 2017 TB diagnostic guidelines of the American Thoracic Society, Infectious Diseases Society of America and CDC recommend performing an IGRA instead of a TST for patients who are unlikely to be infected with TB, such as most HCPs.2
The performance of Oxford Immunotec's IGRA, the T-SPOT.TB test, specifically in HCP testing is well documented in the largest published study of US HCPs, with over 42,000 T-SPOT.TB tests across 19 geographically diverse hospitals.3 The results of this study demonstrated that the T-SPOT.TB test provided consistently reliable results in both high and low risk real world HCP settings.
About the T-SPOT.TB test
The T-SPOT.TB test is a single-visit blood test for TB screening and is one of only two recommended alternatives to the TB skin test. The T-SPOT.TB test has demonstrated both sensitivity and specificity exceeding 95% and reliability in challenging patient populations, including immunosuppression, in its' pivotal clinical study. The test does not cross react with the BCG vaccine and there is no association between T-SPOT.TB test results and immunocompromised status.4
T-SPOT.TB is available nationally through Quest Diagnostics and regionally through laboratory partners.
About Oxford Immunotec
Oxford Immunotec Global PLC is a global, high-growth diagnostics company focused on developing and commercializing proprietary assays for immunology and infectious disease. The Company's T-SPOT.TB test has been approved for sale in over 50 countries, including the United States, where it has received pre-market approval from the Food and Drug Administration, Europe, where it has obtained a CE mark, as well as Japan and China. The Company is headquartered near Oxford, U.K. and in Marlborough, MA. Additional information can be found at www.oxfordimmunotec.com.
T-SPOT and the Oxford Immunotec logo are trademarks of Oxford Immunotec Ltd.
This release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this release are forward-looking statements. This includes statements about Oxford Immunotec's anticipated plans and objectives, future performance and revenues, financial condition, prospects for sales of its products, growth, strategies, expectations and objectives of management. Forward-looking statements can be identified by the fact that they do not relate strictly to historical or current facts. Forward-looking statements contained in this release reflect Oxford Immunotec's current expectations and are subject to risks and uncertainties. Actual results may differ materially from those projected or implied by forward-looking statements. Other factors that could adversely affect Oxford Immunotec's business and prospects are described under the "Risk Factors" section in its filings with the Securities and Exchange Commission, or the SEC's website, www.sec.gov.
Investors should give careful consideration to these risks and uncertainties. Forward-looking statements contained herein are based on current expectations and assumptions and currently available data and are neither predictions nor guarantees of future events or performance. Investors should not place undue reliance on forward-looking statements contained herein, which speak only as of the date of this release. Oxford Immunotec does not undertake to update or revise any forward-looking statements after they are made, whether as a result of new information, future events, or otherwise, except as required by applicable law.
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1 Sosa LE, Njie GJ, Lobato MN, et al. Tuberculosis Screening, Testing, and Treatment of U.S. Health Care Personnel: Recommendations from the National Tuberculosis Controllers Association and CDC, 2019. MMWR Morb Mortal Wkly Rep 2019.
2 Lewinsohn DM, Leonard MK, LoBue PA, et al. Official American Thoracic Society/Infectious Diseases Society of America/Centers for Disease Control and Prevention clinical practice guidelines: Diagnosis of tuberculosis in adults and children. Clin Infect Dis, 2017
3 King TC, Upfal M, Gottlieb A, et al. T-SPOT. TB Interferon-g Release Assay performance in healthcare worker screening at nineteen US hospitals. Am J Respir Crit Care Med. 2015.
4 Oxford Immunotec. T-SPOT.TB Package Insert PI-TB-US-V6. Abingdon, UK. May 2017