Oxford, UK [Marlborough, MA]; 01 August 2008 – Oxford Immunotec, the global T-cell diagnostic
company, today announced that the U.S. Food and Drug Administration (FDA) has approved a
premarket approval application (PMA) for the T-SPOT.TB test. The T-SPOT.TB test is a laboratorybased
cellular blood test that is intended for use as an aid in the diagnosis of Mycobacterium
tuberculosis infection and disease. T-SPOT.TB improves accuracy and eliminates the logistical
challenges found with the current tuberculin skin test.
The T-SPOT.TB test has been tested in patient groups indicated for screening for TB infection
according to current American Thoracic Society and Center for Disease Control Guidance; such as,
human immunodeficiency virus (HIV) positive persons, recent contacts of TB case patients, patients
with chronic renal failure, children, and immunosuppressed patients¹. T-SPOT.TB is the only blood
test that has demonstrated in a pivotal clinical study both sensitivity and specificity exceeding ninetyfive
percent and reliability in all targeted patient groups.
“This approval represents a significant milestone for the company”, said Peter Wrighton-Smith, CEO
of Oxford Immunotec Ltd. “We have been pleased by the success of T-SPOT.TB in Europe and look
forward to achieving continued success in the United States.”
Jeff Schroeder, President of North America commented that “Healthcare providers have told us that
TB is a serious disease that requires a more accurate diagnostic test like T-SPOT.TB. We are looking
forward to working with clinicians and laboratories so that they may offer their patients and employees
the unique benefits of the T-SPOT.TB test.”
According to the World Health Organization (WHO) there were an estimated 8.8 million new cases of
tuberculosis and 1.6 million deaths attributed to the disease worldwide in 2007. In the United States
there is an estimated 10-15 million individuals infected with latent TB.