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Oxford Immunotec announces US FDA
approval of PMA supplement for the use of the T-Cell Xtend® reagent
Oxford, UK [Marlborough, MA]; 11 August 2010 – Oxford Immunotec Ltd, the
T-cell measurement company, today announces that it has received
approval of a PMA supplement for the use of the T-Cell Xtend reagent.
Use of this product enables customers to store whole blood overnight
prior to processing in the T-SPOT®.TB assay.
Interferon Gamma Release Assays (IGRA) performance (such as the
T-SPOT.TB test) is affected by blood storage time and, therefore, the
tests have been limited by the need to process the blood sample on the
same day as phlebotomy (typically 8 – 16 hours with current commercial
tests). The T-Cell Xtend reagent removes this time constraint by
allowing blood to be drawn and shipped to any local or centralized
laboratory overnight with no impact on the performance of blood in the
T-SPOT.TB assay. The T-Cell Xtend reagent works by reversing the
degradation that the sample would otherwise suffer during storage.
Commenting on the approval, Dr Peter Wrighton-Smith, Chief Executive
Officer of Oxford Immunotec, said, "This is our fourth PMA supplement to
be approved by the FDA in the last 12 months and represents another
significant milestone for Oxford Immunotec. The use of T-Cell Xtend
reagent allows much greater flexibility to
T-SPOT.TB test customers in processing samples as they can be shipped to
the laboratory overnight rather than having to be processed on the same
day as collection". |