Oxford Immunotec Announces Food and Drug Administration (FDA) Clearance of the T-SPOT®.TB Test for Use in Pediatrics Over the Age of Two
The T-SPOT.TB test is now the only interferon-gamma release assay (IGRA) cleared for use in children ages two and upwards in the United States.
OXFORD, United Kingdom and MARLBOROUGH, Mass., September 29, 2020 (GLOBE NEWSWIRE) — Oxford Immunotec Global PLC (Nasdaq:OXFD) (the “Company”), a global, high-growth diagnostics company, today announced that it has received clearance from the FDA to amend the pediatric age limitation to allow use of the T-SPOT.TB test in individuals two years of age and older.
“This clearance fills an unmet need, as many pediatric patients are still TB screened using the antiquated tuberculin skin test. Removing this pediatric limitation further demonstrates the strong clinical performance of the T-SPOT.TB test across a spectrum of patient populations,” said Dr. Peter Wrighton-Smith, Chief Executive Officer of Oxford Immunotec. “This clearance comes at a perfect time for pediatric patients, parents and providers. Completing TB screening in one office visit is critical during this pandemic. Whether it’s a TB screen due to patient risk or a mandatory test for a school physical, providers can now confidently complete their pediatric patient screen in one visit with an FDA approved diagnostic.”
The T-SPOT.TB test is available nationally through Quest Diagnostics® and through regional laboratory partners.
For additional information about the T-SPOT.TB test, visit www.tspot.com.
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 tuberculin skin test (TST) – otherwise known as purified protein derivative (PPD) test, or the Mantoux test. The T-SPOT.TB test is available in over 50 countries including Europe, China, Japan and the US, and is recognized by the WHO as one of the 100 essential diagnostic tests that should be available in every country. The T-SPOT.TB test uses a standardized sample, reducing the influence of factors in the blood which may affect performance, and normalizing for cell number variation. The test has been shown to have a sensitivity of 95.6% and a specificity in excess of 97.1%, and is able to maintain performance even in samples otherwise difficult to test, such as samples from immunosuppressed patients. The T-SPOT.TB test does not cross-react with the BCG vaccine1. Automation of the T-SPOT.TB test is possible using the T-Cell SelectTM reagent kit. Automation solutions are available for low, medium and high throughput settings2. The T-Cell Select reagent kit also enables samples to be stored at ambient temperature for up to 54 hours after blood is collected.
About Oxford Immunotec
Oxford Immunotec Global PLC is a global, high-growth diagnostics company. We bring energy and invention to a world in need of diagnostic truth. Our leading product, the T-SPOT.TB test is used for diagnosing infection with Tuberculosis, the world’s largest cause of death from infectious disease. The 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 Limited.
T-Cell Select is a trademark of Oxford Immunotec Ltd. Quest Diagnostics is a registered trademark of Quest Diagnostics.
Certain statements in this press release constitute forward-looking statements within the meaning of applicable U.S. and U.K. laws and regulations, including under the U.S. Private Securities Litigation Reform Act of 1995. Any statements contained herein which do not describe historical or current facts, including statements about Oxford Immunotec’s plans to ensure that when the COVID-19 disruption eases, Oxford Immunotec is best positioned to meet the needs of the TB market and drive long-term growth and statements regarding uncertainties around the impact of COVID-19 on Oxford Immunotec’s revenues and results of operations, constitute forward-looking statements. Any forward-looking statements are based on our management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks that the COVID-19 pandemic may disrupt the company’s business and the global healthcare system more severely than anticipated, as well as those other risks described in Oxford Immunotec’s filings with the U.S. Securities and Exchange Commission (the “Commission”), including the company’s Annual Report on Form 10-K for the year-ended December 31, 2019 and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, and in any other reports it subsequently files with the Commission, including any other Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. Oxford Immunotec’s filings with the Commission are available for free by visiting the investor section of our website, www.oxfordimmunotec.com, or the Commission’s website, www.sec.gov.
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1 Oxford Immunotec. T-SPOT.TB Package Insert PI-TB-US-0001 V8. Abingdon, UK. September 2020.
2 Note that not all products and reagents are approved or available in all jurisdictions, including the US. Please contact us for details on availability in your country.