Oxford Immunotec Announces Availability of the T-SPOT.CMV Test in the United States
OXFORD, UK and MARLBOROUGH, MA, March 31, 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 the availability in the United States of a new test that measures the strength of a patient’s cellular immune response to cytomegalovirus (CMV). This T-SPOT®.CMV test is available as a Laboratory Developed Test from the Company’s CLIA-certified and CAP accredited service laboratory.
“We are pleased to provide physicians the T-SPOT.CMV test earlier than our previously announced timeline,” 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.CMV test 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 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.
The T-SPOT.CMV test leverages Oxford Immunotec’s proprietary T-SPOT technology platform. The new test will be performed at Oxford Diagnostic Laboratories in Memphis, TN, where validation was performed. The test results will be available to customers within two days of receipt of a whole blood sample. The T-SPOT.CMV test builds on Oxford Immunotec’s capabilities in T cell measurement technology, and is the first in a series of planned new products intended to help transplant patients and physicians manage immune regulated conditions.
The T-SPOT.CMV test is pending approval in California, New York and Florida.
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 of three products we intend to launch 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.
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