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April 1, 2015

Oxford Immunotec launches T cell test

Oxford Immunotec of Marlborough has developed a laboratory test that measures a patient’s immunity to cytomegalovirus (CMV), a herpes virus.

The medical diagnostics company —which has dual headquarters in Marlborough and England — said in a statement that its T-SPOT.CMV test is available in the U.S. sooner than expected, although approvals are pending in California, Florida and New York. It’s a laboratory developed test (LDT), which means it’s designed, manufactured and used within a single laboratory.

The test evaluates T cell response to CMV-specific antigens, and will be performed at Oxford Diagnostic Laboratories in Memphis.

The T-SPOT.CMV test leverages Oxford Immunotec's proprietary T-SPOT technology platform, Tuesday’s statement said. The test “is the first in a series of planned new products intended to help transplant patients and physicians manage immune regulated conditions,” the statement said.

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 statement said.

Full commercial launch is expected in the second half of 2016. CEO Peter Wrighton-Smith said in the statement that the company is taking a measured approach to market introduction as it awaits results of clinical trials.

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