T-Spot Cytomegalovirus Test Receives CE Marking Approval

By LabMedica International staff writers
Posted on 23 Jun 2015

Cytomegalovirus is an important and common cause of morbidity and mortality in solid organ and hematopoietic stem cell transplant recipients.

T-cell immunity against Cytomegalovirus (CMV) is a factor in controlling viral latency and susceptibility to CMV disease and CMV can affect individuals with weaknesses in their T- cell response.

Image: Cytomegalovirus infection with basophilic nuclear inclusions with perinuclear halo and granular basophilic cytoplasmic inclusions (Photo courtesy of Dr. Yale Rosen, MD).

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 antiviral prophylaxis and evaluating patients at risk from CMV disease. The test has recently gained Conformité Européenne (CE) marking and is pending approval in California, New York and Florida.

The T-SPOT.CMV test (Oxford Immunotec Global PLC, Oxford, UK) leverages the company’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 the UK Oxford Diagnostic Laboratory (ODL). T-SPOT.CMV is also available in the USA as a Laboratory Developed Test from the Company’s Clinical Laboratory Improvement Amendments (CLIA)-certified and College of American Pathologists (CAP) accredited ODL service laboratory.

Peter Wrighton-Smith, PhD, Chief Executive Officer of Oxford Immunotec, said, “We are pleased our T-SPOT.CMV test gained CE Mark approval earlier than our expectations. 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.”

A study 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 was presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) meeting held April 25–28, 2015, in Copenhagen (Denmark).

Related Links:
Oxford Immunotec Global PLC