Oxford Immunotec Files Submission to Food and Drug Administration (FDA) for the T-Cell Select™ Reagent Kit

Rhea-AI Summary

Oxford Immunotec Global PLC (Nasdaq: OXFD) announced the FDA submission for the T-Cell Select reagent kit, facilitating automated sample preparation for the T-SPOT® .TB test. This submission aims to meet strong demand for automation from lab partners, enhancing logistics by allowing samples to be processed up to 54 hours post-collection without refrigeration. The T-SPOT.TB test has already received FDA clearance for pediatric use and boasts a sensitivity of 95.6% and a specificity exceeding 97.1%. The reagent kit is currently available in Europe and expanding globally.

Positive

• FDA submission for T-Cell Select reagent kit aimed at enhancing automation in TB testing.
• T-Cell Select kit allows sample processing up to 54 hours without refrigeration.
• Recent FDA clearance of T-SPOT.TB test for pediatric patients enhances market reach.
• High sensitivity (95.6%) and specificity (>97.1%) of T-SPOT.TB test strengthens product credibility.

Negative

• None.

If approved, the T-Cell Select reagent kit would enable automated sample preparation and the T-SPOT^®.TB test to be used with blood samples stored for up to 54 hours at room temperature

OXFORD, United Kingdom and MARLBOROUGH, Mass., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Oxford Immunotec Global PLC (Nasdaq:OXFD) (the “Company”), a global, high-growth diagnostics company, today announced that it has filed its FDA submission for the T-Cell Select reagent kit.

“Filing to the FDA for T-Cell Select approval is a critical first step to bring automation to U.S. customers,” said Dr. Peter Wrighton-Smith, the company’s Chief Executive Officer. “There is strong demand from our lab partners and the market to automate the T-SPOT.TB test cell separation process and this reagent kit opens the door for laboratories of varying throughput requirements.” The T-Cell Select reagent kit also improves logistics and laboratory flexibility, allowing T-SPOT.TB samples to be processed up to 54 hours after collection without field-based incubation or refrigeration.

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.

“This submission builds on our recent FDA clearance of the T-SPOT.TB test as the only TB blood test cleared for use in pediatric patients ages two and up, adding workflow improvements on top of the recent extensions to clinical utility,” said Peter Wrighton-Smith.

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 uses a standardized sample, reducing the influence of factors in the blood which may affect performance, and normalizing for cell number variation. In the U.S., 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 and BCG-vaccinated patients.¹

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, T-Cell Select and the Oxford Immunotec logo are trademarks of Oxford Immunotec Limited.

Forward-Looking Statements

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. Such forward-looking statements may be identified by words such as “anticipates,” “believes,” “expects,” “plans,” “intends,” “projects,” and “future” or similar expressions that are intended to identify 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 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 quarters ended March 31, 2020, June 30, 2020 and September 30, 2020, and in any other reports it 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.

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.

CONTACTS:

For Media and Investor Inquiries:
Matt McLaughlin
Chief Financial Officer
Oxford Immunotec
Tel: +1 (508) 573-9953
mtmclaughlin@oxfordimmunotec.com

[1] Oxford Immunotec. T-SPOT.TB Package Insert PI-TB-US-0001 V8. Abingdon, UK. September 2020.

 

FAQ

What is the significance of OXFD's FDA submission for the T-Cell Select reagent kit?

The FDA submission for the T-Cell Select reagent kit is crucial for automating the T-SPOT.TB test process, responding to market demand and enhancing laboratory efficiency.

How does the T-Cell Select reagent kit improve TB testing logistics for OXFD?

The kit allows blood samples to be processed up to 54 hours post-collection without the need for refrigeration, improving logistical flexibility.

What recent approval did OXFD receive related to pediatric use?

OXFD received FDA clearance for the T-SPOT.TB test, making it the only TB blood test approved for use in pediatric patients two years and older.

What are the performance metrics of the T-SPOT.TB test from OXFD?

The T-SPOT.TB test has a sensitivity of 95.6% and a specificity exceeding 97.1%, demonstrating robust performance for TB screening.

In which regions is the T-Cell Select reagent kit available?

The T-Cell Select reagent kit has been available throughout Europe and is quickly expanding into other global markets.