NEW YORK — Oxford Immunotec said on Tuesday that it has received clearance from the US Food and Drug Administration to amend the pediatric age limitation for its T-Spot.TB tuberculosis (TB) test to include individuals two years of age and older.
T-Spot.TB is a single-visit blood test for TB screening and one of two recommended alternatives to the traditional tuberculin skin test, Oxford Immunotec said. It uses a standardize sample to normalize for cell number variation and other factors that may affect performance, does not cross-react with the BCG tuberculosis vaccine, and has demonstrated a sensitivity of 95.6 percent and a specificity greater than 97 percent.
"This clearance fills an unmet need, as many pediatric patients are still TB screened using the antiquated tuberculin skin test," Oxford Immunotec CEO Peter Wrighton-Smith said in a statement.
T-Spot.TB is available in the US through Quest Diagnostics under a long-term supply agreement, as well as through regional laboratory partners.
In July, Oxford, UK-based Oxford Immunotec signed an agreement to supply the test and associated accessories to the Stop TB Partnership — Global Drug Facility.