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T-Spot TB gains FDA premarket approval

This article was originally published in Clinica

Executive Summary

The US FDA has granted premarket approval (PMA) for UK firm Oxford Immunotec's T-Spot TB test. The Mycobacterium tuberculosis diagnostic is a laboratory-based cellular blood test that the firm claims is more accurate than the current tuberculin skin test. T-Spot TB has demonstrated both sensitivity and specificity exceeding 95% when tested in patient groups indicated for TB screening. The test is approved for sale in Europe, Canada and over 40 other countries, Oxford Immunotec said. The World Health Organization (WHO) estimates that there were 8.8 million new cases of tuberculosis and 1.6 million deaths from the disease worldwide in 2007, a market opportunity exceeding $1bn. In the US there are an estimated 10-15 million people infected with latent TB.

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