Oxford Immunotec Announces CE Mark for the T-SPOT.PRT Test
OXFORD, United Kingdom and MARLBOROUGH, Mass., 2015-12-22 22:45 CET (GLOBE NEWSWIRE) -- Oxford Immunotec Global PLC (Nasdaq:OXFD), a global, commercial-stage diagnostics company focused on developing and commercializing proprietary tests for the management of immune-regulated conditions, today announced that it gained CE marking for the T-SPOT®.PRTtest. The panel of reactive T cells (PRT) test assesses a solid organ transplant candidate’s T cell response to foreign tissue, referred to as alloreactivity.
Alloreactivity is the body’s reaction to foreign tissue. In transplant, understanding the likelihood of a rejection event is an important factor in patient management. A T cell immune response to the donated organ can lead to T cell mediated rejection (TCMR), which is a complication detrimental to the survival of the transplanted organ. The T-SPOT.PRTtest measures a transplant candidate’s T cell mediated response to cells representing the potential donor population. This test may help clinicians identify patients at increased risk of TCMR, which in turn may guide decisions regarding immunosuppressive therapies.
"We are pleased the T-SPOT.PRTtest gained CE marking this year as anticipated," said Dr. Peter Wrighton-Smith, Chief Executive Officer of Oxford Immunotec. "While we are enthusiastic about the potential clinical utility and economic value that the T-SPOT.PRTtest may provide in transplant medicine, we are taking a measured approach to market introduction as we await the results of our PROTECT clinical trial."
The T-SPOT.PRTtest leverages Oxford Immunotec's proprietary T-SPOT technology platform and the CE-marked kit will be offered as a testing service from our UK ODL laboratory. The T-SPOT.PRTtest is also available in the US as a laboratory developed test from the Company’s CLIA-certified and CAP accredited service laboratory1. The T-SPOT.PRTtest builds on Oxford Immunotec's capabilities in T cell measurement technology, and is the second in a series of planned new products intended to help transplant patients and physicians manage immune regulated conditions.
About Oxford Immunotec
Oxford Immunotec Global PLC is a global, commercial-stage diagnostics company focused on developing and commercializing proprietary tests for the management of immune-regulated conditions. The Company's first product is the T-SPOT.TBtest, which is used to test for tuberculosis infection. The T-SPOT.TBtest 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 T-SPOT.CMVtest and the T-SPOT.PRTtest are the Company's second and third products and part of a series of products intended for the transplantation market. In addition to these three products, the Company has an additional six active development programs, each of which leverages our T cell, B cell and innate immune measuring technology. The Company is headquartered near Oxford, U.K. and in Marlborough, Mass. Additional information can be found atwww.oxfordimmunotec.com.
T-SPOT and the Oxford Immunotec logo are trademarks of Oxford Immunotec Ltd.
1. The T-SPOT.PRTtest is pending approval in California, New York and Florida.
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