Oxford Immunotec Announces New Data on the Utility of T-SPOT®.CMV in Kidney and Stem Cell Transplant
OXFORD, United Kingdom and MARLBOROUGH, Mass., February 20, 2020 (GLOBE NEWSWIRE) — Oxford Immunotec Global PLC (Nasdaq:OXFD) (the “Company”), a global, high-growth diagnostics company, today announces two ground-breaking publications in Clinical Infectious Diseases(CID) on the performance of T-SPOT.CMV; a test for measuring the strength of a patient’s cellular immune response to Cytomegalovirus (CMV) in kidney and stem cell transplant. Increased response in the T-SPOT.CMV test is associated with protection against CMV infection. Application of the test raises the prospect of improved, individualized management of CMV infection risk in transplant recipients.
The key findings from the RESPECT(1) study in kidney transplant recipients are:
T-SPOT.CMV provides clear stratification of patients for probability of CMV infection
Pre-transplant testing with T-SPOT.CMV identifies kidney transplants at high risk of developing CMV infection
Application of the test soon after transplant further refines CMV infection risk
The key findings from the REACT(2) study in stem cell transplant recipients are:
Patients with a low response in the T-SPOT.CMV test were at increased risk for clinically significant CMV infection
The T-SPOT.CMV test result was a significant and independent predictor of clinically significant CMV infection
Patients with low response in the T-SPOT.CMV test and clinically significant CMV had the highest all-cause mortality
Dr. Oriol Bestard, Head of Kidney Transplant Unit, Bellvitge University Hospital of Barcelona, Spain and lead author on the study explained, “The RESPECT study evidence demonstrates that T-SPOT.CMV accurately predicts the risk of CMV infection. The results of this study provide an opportunity for implementing personalized medicine to manage CMV infection in kidney transplantation.”
Additionally, Dr. Roy F Chemaly, Director of the clinical virology research program, UT MD Anderson Cancer Center of Houston, TX and lead author on the REACT study commented, “This is the largest report to establish clinical performance characteristics for T-SPOT.CMV in stem cell transplant patients. T-SPOT.CMV, as part of a surveillance strategy, could help identify patients at risk of CMV infection.”
“We’re pleased with the results from the RESPECT study which validate the clinical utility of T-SPOT.CMV in kidney transplant. This test addresses an unmet need and brings clinical and economic value to the transplant setting,” said Dr. Peter Wrighton-Smith, Chief Executive Officer of Oxford Immunotec. “Additionally, the data generated from the REACT study also shows that the T-SPOT.CMV test accurately predicts CMV infection in stem cell transplant patients. We’re excited to begin the process of bringing the benefits of this test to the kidney and stem cell transplant setting.”
About the T-SPOT.CMV test
The T-SPOT.CMV test leverages Oxford Immunotec’s proprietary T-SPOT technology platform to measure the strength of a patient’s cellular immune response to antigens specific to CMV. 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 has the potential to assist clinicians with monitoring anti-viral prophylaxis and evaluating patients at risk from CMV infection. T cell immunity against CMV is a factor in controlling viral latency and susceptibility to CMV infection, a common and serious complication in both solid organ and stem cell transplantation.
About Oxford Immunotec
Oxford Immunotec Global PLC is a global, high-growth diagnostics company focused on developing and commercializing proprietary assays for immunology and infectious disease. The Company’s 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 Ltd.
This release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this release are forward-looking statements. This includes statements about Oxford Immunotec’s anticipated plans and objectives, future performance and revenues, financial condition, prospects for sales of its products, growth, strategies, expectations and objectives of management. Forward-looking statements can be identified by the fact that they do not relate strictly to historical or current facts. Forward-looking statements contained in this release reflect Oxford Immunotec’s current expectations and are subject to risks and uncertainties. Actual results may differ materially from those projected or implied by forward-looking statements. Other factors that could adversely affect Oxford Immunotec’s business and prospects are described under the “Risk Factors” section in its filings with the Securities and Exchange Commission (“SEC”). Oxford Immunotec’s SEC filings are available for free by visiting the investor section of its website, www.oxfordimmunotec.com, or the SEC’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.
(1) Bestard O et al. Cellular Immunity to Predict the Risk of Cytomegalovirus Infection in Kidney Transplantation: A Prospective, Interventional, Multicenter Clinical Trial. Clinical Infectious Diseases, ciz1209
(2) Chemaly R et al. CMV Cell-Mediated Immunity and CMV Infection After Allogeneic Hematopoietic Cell Transplantation: The REACT Study. Clinical Infectious Diseases, ciz1210
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