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Oxford Immunotec Announces Agreement with Stop TB Partnership - Global Drug Facility (GDF) to Provide Access to the T-SPOT®.TB Test for 100+ TB Burden Countries

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Oxford Immunotec Global PLC (Nasdaq: OXFD) announced a long-term agreement to supply its T-SPOT.TB test to the Stop TB Partnership - Global Drug Facility (GDF). This follows the inclusion of the test in GDF’s diagnostics catalog, enhancing access for TB diagnostics in over 140 countries. The T-SPOT.TB test, recognized by WHO, demonstrates a 98.8% sensitivity and over 99% specificity, catering to challenging patient populations. This collaboration aims to address TB diagnostic needs, particularly in high-burden nations.

Positive
  • Long-term agreement with GDF to supply T-SPOT.TB test enhances market reach.
  • T-SPOT.TB test included in GDF's diagnostics catalog, facilitating global access.
  • Test shows high sensitivity (98.8%) and specificity (over 99%) for TB diagnosis.
Negative
  • None.

OXFORD, United Kingdom and MARLBOROUGH, Mass., July 20, 2020 (GLOBE NEWSWIRE) -- Oxford Immunotec Global PLC (Nasdaq:OXFD) (the "Company"), today announced that it has entered into a long-term agreement to supply its T-SPOT.TB test and associated accessories to the Stop TB Partnership - Global Drug Facility (GDF). This follows the inclusion of the T-SPOT.TB test in the GDF’s diagnostics catalog for the detection of tuberculosis (TB) infection.

The GDF is the largest global provider of quality-assured TB medicines, diagnostics and laboratory supplies since its creation in 2001. GDF has facilitated access to TB medicines and diagnostics in more than 140 countries. In 2019 alone, GDF delivered nearly USD$264 million worth of TB medicines and diagnostics to 116 countries. GDF has led the introduction of advanced diagnostic and supplies in countries to support TB diagnosing.

“We are excited to collaborate with GDF to use their procurement mechanism and provide the T-SPOT.TB test to countries not previously served by the company,” said Peter Wrighton-Smith, CEO of Oxford Immunotec. “Inclusion in the GDF’s diagnostic catalog makes our test more accessible to countries that are most in need of an accurate, reliable TB test that works in challenging patient populations, including children and those with immunosuppression, who are likely the first targets for new latent TB testing programs.”

The GDF makes the T-SPOT.TB test available in countries with TB burden and therefore with a need for TB diagnostics. National TB control programs may now order the T-SPOT.TB test directly through the GDF’s procurement mechanism. The GDF product catalog and procurement process is outlined on the GDF website (http://www.stoptb.org/gdf/). The following link provides the steps for ensuring timely processing of orders via GDF: http://www.stoptb.org/gdf/placeOrder.asp.

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 60 countries including Europe, China, Japan and the US, and is recognized by the WHO as one 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. It has been shown to have a sensitivity of 98.8% and a specificity in excess of 99%, 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 60 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.

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. 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

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-IVD-UK v3. Abingdon, UK. 2016
2 Note that not all products and reagents are available in all countries; please contact us for details on availability in your country.


FAQ

What is the significance of Oxford Immunotec's agreement with GDF?

The agreement allows Oxford Immunotec to supply T-SPOT.TB tests to countries in need of reliable TB diagnostics, significantly enhancing its market reach.

How does the T-SPOT.TB test perform in clinical settings?

The T-SPOT.TB test has a sensitivity of 98.8% and a specificity exceeding 99%, making it suitable for diverse patient populations, including immunosuppressed individuals.

In how many countries is the T-SPOT.TB test available?

The T-SPOT.TB test is available in over 60 countries, including Europe, the US, Japan, and China.

What does the inclusion of the T-SPOT.TB test in GDF's catalog mean?

Inclusion in GDF's catalog means that national TB control programs can now directly order the test to improve TB diagnostic capabilities.

What is the role of the Stop TB Partnership - Global Drug Facility?

The GDF is the largest global provider of quality-assured TB medicines and diagnostics, facilitating access in over 140 countries.

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