Oxford Immunotec Announces the Approval of the T-Cell Select™ Reagent Kit, Used to Automate the T-SPOT®.TB Test Workflow, for IVD Use in South Korea
Oxford Immunotec Global PLC (Nasdaq: OXFD) has received approval from South Korea's Ministry of Food and Drug Safety for its T-Cell Select reagent kit. This kit simplifies the T-SPOT.TB test process by automating cell preparation from blood samples, reducing labor costs and improving laboratory integration. It allows for sample storage at room temperature for up to 54 hours, enhancing workflow flexibility. CEO Peter Wrighton-Smith highlighted that this approval will facilitate wider adoption of the T-SPOT.TB test in South Korea, benefiting more patients.
- Approval of T-Cell Select reagent kit by South Korea enhances market presence.
- Automation of the T-SPOT.TB test reduces labor costs and simplifies lab workflow.
- Extended sample storage at room temperature increases logistical flexibility.
- None.
OXFORD, United Kingdom and MARLBOROUGH, Mass., Dec. 10, 2020 (GLOBE NEWSWIRE) -- Oxford Immunotec Global PLC (Nasdaq: OXFD) (the “Company”), a global, high-growth diagnostics company today announced that the Company’s T-Cell Select reagent kit has been approved for use by the Ministry of Food and Drug Safety, South Korea.
The T-Cell Select reagent kit is an immune cell separation reagent. It is used to automate the preparation of the cells required to run the Company’s T-SPOT.TB test, for diagnosis of TB infection, from patient blood samples.
The T-Cell Select reagent kit streamlines and simplifies the T-SPOT.TB test laboratory protocol. Automation makes implementation of the T-SPOT.TB test easy, reducing hands-on time and saving on labour costs. It also allows for higher throughput and easier integration of the T-SPOT.TB test into the laboratory workflow.
The T-Cell Select reagent kit also has additional advantages. It allows samples to be stored for up to 54 hours at room temperature before use, enabling easy centralisation of sample processing and simplifying sample logistics. This also gives laboratories more flexibility as it allows time for sample batching.
Peter Wrighton-Smith, CEO of Oxford Immunotec, said “The approval of T-Cell Select is a major step forward in simplifying the workflow for our T-SPOT.TB test in South Korea. It will enable adoption of the test in many more labs throughout the country and most importantly will extend the benefits of our test to more patients.”
The T-Cell Select reagent kit has been available throughout Europe under CE mark and is quickly becoming available in more markets around the world.
For additional information, please visit: http://www.oxfordimmunotec.com/international/products-services/t-cell-select/.
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. We are uniquely placed as the only company in the world offering regulated ELISPOT assays for T cell measurement, with approval around the globe. 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 Company is an experienced manufacturer of IVD tests, operating under a fully audited Quality Management System, ensuring rigorous batch control. The company has manufactured in excess of 20 million clinical T cell tests for TB infection. 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, the Oxford Immunotec logo, and T-Cell Select are trademarks of Oxford Immunotec Limited.
Forward-Looking Statements
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 (“SEC”). Oxford Immunotec’s SEC filings are available for free by visiting the investor section of its website, www.oxfordimmunotec.com, 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.
For Investor Inquiries:
Matt McLaughlin
Chief Financial Officer
Oxford Immunotec
Tel: +1 (508) 573-9953
mtmclaughlin@oxfordimmunotec.com
FAQ
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