News | April 27, 2015
Oxford Immunotec Announces CE Mark Approval for T-SPOT.CMV Test
Product to be featured at a symposium at the European Congress of Clinical Microbiology and Infectious Disease
OXFORD, UK and MARLBOROUGH, MA, April 27th, 2015 (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 had gained CE Marking for its T-SPOT®.CMV test.
“We are pleased our T-SPOT.CMV test gained CE Mark approval earlier than our expectations,” said Dr. Peter Wrighton-Smith, Chief Executive Officer of Oxford Immunotec. “While we are enthusiastic about the potential clinical and economic value T-SPOT.CMV may provide in transplant medicine we are taking a measured approach to market introduction as we await the results of our PROTECT and REACT clinical trials. We continue to expect full commercial launch in the second half of 2016.”
T cell immunity against cytomegalovirus (CMV) is a factor in controlling viral latency and susceptibility to CMV disease. CMV can affect individuals with weaknesses in their T cell response and it is therefore an important and common cause of morbidity and mortality in solid organ and hematopoietic stem cell transplant recipients. The T-SPOT.CMV test measures the strength of T cell responses to CMV specific antigens. The T-SPOT.CMV test has the potential to assist clinicians with monitoring anti-viral prophylaxis and evaluating patients at risk from CMV disease.
“Measuring T Cell Mediated CMV / TB Response with ELISPOT Technology” is the subject of an integrated symposium that will be held tomorrow, April 28, at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) meeting in Copenhagen, Denmark. Investigators Dr. Roy Chemaly and Dr. Oriol Bestard Matamoros will be presenting their experience using the T-SPOT technology for immune monitoring and T cell response to CMV in hematopoietic stem cell transplant patients and solid organ transplant patients.
The T-SPOT.CMV test leverages Oxford Immunotec’s proprietary T-SPOT technology platform, and is the first in a series of planned new products intended to help transplant patients and physicians manage immune regulated conditions. The test is available now as a CE-marked kit in the EU, and will soon be available in the UK as a testing service from our UK ODL laboratory. T-SPOT.CMV is also available in the US as a Laboratory Developed Test from the Company’s CLIA-certified and CAP accredited ODL service laboratory1.
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.TB test, which is used to test for tuberculosis 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 T-SPOT.CMV test is the Company’s second product and the first in a series of products intended for the transplantation market. Overall, the Company has six active development programs, each of which leverages our T cell and innate immune measuring technology. The Company is headquartered near Oxford, UK 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 Ltd.
1. The T-SPOT.CMV test is pending approval in California, New York and Florida
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